VADo DLLACPG092817

VA/DoD CLINICAL PRACTICE GUIDELINE FOR
REHABILITATION OF INDIVIDUALS WITH

LOWER LIMB AMPUTATION
Department of Veterans Affairs
Department of Defense
QUALIFYING STATEMENTS
The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best
information available at the time of publication. They are designed to provide information and assist
decision making. They are not intended to define a standard of care and should not be construed as one.
Neither should they be interpreted as prescribing an exclusive course of management.
This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological
evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical
relationships between various care options and health outcomes while rating both the quality of the
evidence and the strength of the recommendation.
Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of
individual patients, available resources, and limitations unique to an institution or type of practice. Every
healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of
applying them in the setting of any particular clinical situation.
These guidelines are not intended to represent Department of Veterans Affairs or TRICARE policy.
Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these
guidelines does not guarantee coverage of civilian sector care. Additional information on current
TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed
Care Support Contractor.
Version 2.0 – 2017

Prepared by:
The Rehabilitation of Individuals with Lower Limb Amputation

Work Group
With support from:
The Office of Quality, Safety and Value, VA, Washington, DC

&
Office of Evidence Based Practice, U.S. Army Medical Command
Version 2.0 – 2017
Based on evidence reviewed through July 2016
September 2017 Page 2 of 123

VA/DoD Clinical Practice Guideline for Rehabilitation of Individuals with Lower Limb Amputation
Table of Contents
I. Introduction..................................................................................................................................... 5
II. Recommendations ........................................................................................................................... 6
III. Background...................................................................................................................................... 8
A. Description of Lower Limb Amputation .............................................................................................. 8
B. Epidemiology and Impact .................................................................................................................... 9
C. Lower Limb Amputation in the Department of Veterans Affairs and the Department of
Defense .............................................................................................................................................. 10
D. Factors Affecting Rehabilitation of Lower Limb Amputation........................................................... 10
IV. About this Clinical Practice Guideline ............................................................................................. 11

A. Methods ............................................................................................................................................. 11
B. Summary of Patient Focus Group Methods and Findings................................................................ 15
C. Conflict of Interest ............................................................................................................................. 16
D. Scope of this Clinical Practice Guideline ........................................................................................... 16
E. Highlighted Features of this Clinical Practice Guideline ................................................................... 17
F. Patient-centered Care ....................................................................................................................... 18
G. Shared Decision Making .................................................................................................................... 18
H. Implementation ................................................................................................................................. 18
V. Guideline Work Group ................................................................................................................... 20
VI. Algorithm ...................................................................................................................................... 21

Module A: Transdisciplinary Amputation Care Team Approach (TACT) .................................................. 22
Module B: Primary Care Follow-up and Lifelong Care.............................................................................. 23
VII. Discussion of Recommendations .................................................................................................... 24

A. All Phases of Amputation Rehabilitation .......................................................................................... 24
B. Perioperative Phase ........................................................................................................................... 31
C. Pre-Prosthetic Phase.......................................................................................................................... 39
D. Prosthetic Training Phase .................................................................................................................. 40
VIII. Knowledge Gaps and Recommended Research .............................................................................. 46

A. Training programs.............................................................................................................................. 46
B. Rehabilitation dosing ......................................................................................................................... 47
C. Patient factors and considerations ................................................................................................... 47
D. Cognitive assessment ........................................................................................................................ 47
E. Perioperative LLA interventions ........................................................................................................ 47

F. Prosthetic interventions .................................................................................................................... 47
Appendix A: Evidence Review Methodology....................................................................................... 48

A. Developing the Scope and Key Questions ........................................................................................ 48
B. Conducting the Systematic Review ................................................................................................... 52
C. Convening the Face-to-face Meeting................................................................................................ 56
D. Grading Recommendations............................................................................................................... 57
E. Recommendation Categorization ..................................................................................................... 60
F. Drafting and Submitting the Final Clinical Practice Guideline.......................................................... 62
Appendix B: Evidence Table ............................................................................................................... 64
Appendix C: 2007 Recommendation Categorization Table.................................................................. 68
Appendix D: Participant List................................................................................................................ 99
Appendix E: Patient Focus Group Methods and Findings .................................................................. 101

A. Methods ........................................................................................................................................... 101
B. Patient Focus Group Findings.......................................................................................................... 101
Appendix F: Literature Review Search Terms and Strategy ............................................................... 104

A. Topic-specific Search Terms ............................................................................................................ 104
B. Search Strategies ............................................................................................................................. 110
Appendix G: Abbreviation List........................................................................................................... 115
References .......................................................................................................................................... 117

I. Introduction
The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice
Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health
Executive Council on the use of clinical and epidemiological evidence to improve the health of the
population across the Veterans Health Administration and Military Health System,” by facilitating the
development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] This CPG is
intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the
individual needs and preferences of patients with lower limb amputation (LLA), thereby leading to
improved clinical outcomes.
In 2007, the VA and DoD published a CPG for the Rehabilitation of Lower Limb Amputation (2007 LLA CPG),
which was based on evidence reviewed through December 2006. Since the release of that guideline, a
growing body of research has expanded the general knowledge and understanding of LLA. Improved
recognition of the complex nature of this condition has led to the adoption of new strategies for
rehabilitation of LLA.
Consequently, a recommendation to update the 2007 LLA CPG was initiated in 2016. The updated CPG
includes objective, evidence-based information on the rehabilitation of LLA. It is intended to provide
guidance to assist healthcare providers in perioperative, pre-prosthetic training, and prosthetic training
phases of patient care. The system-wide goal of evidence-based guidelines is to improve the patient’s
health and well-being by guiding healthcare providers who are assisting patients in rehabilitation after LLA
along the management pathways that are supported by evidence. The expected outcome of successful
implementation of this guideline is to:
• Assess the patient’s condition and in collaboration with the patient, determine the most
appropriate rehabilitation plan
• Optimize each individual’s functional independence, health outcomes, and quality of life
• Minimize preventable complications and morbidity
• Emphasize the use of patient-centered care

II. Recommendations
# Recommendation Strength* Category†
A. All Phases of Amputation Rehabilitation
1. We suggest that patient education be provided by the rehabilitation care team Weak for Reviewed,
throughout all phases of amputation rehabilitation. Amended
2. We suggest an assessment of behavioral health and psychosocial functioning at Weak for Reviewed,
every phase of amputation management and rehabilitation. Amended
3. When assessing pain, we suggest that measurement of the intensity of pain and Weak for Reviewed,
interference with function should be separately assessed for each pain type and Amended
location using standardized tools.
4. We suggest offering a multi-modal, transdisciplinary individualized approach to Weak for Reviewed,
pain management including transition to a non-narcotic pharmacological regimen New-replaced
combined with physical, psychological, and mechanical modalities throughout
the rehabilitation process (For the treatment of chronic pain, the 2017 VA/DoD
CPG for the Management of Opioid Therapy for Chronic Pain recommends
alternatives to opioid therapy such as self-management strategies, other non-
pharmacological treatments, and non-opioids over opioids [see the 2017 VA/DoD
OT CPG 1]).
5. We recommend providers consider the patient’s birth sex and self-identified Strong for Reviewed,
gender identity in developing individualized treatment plans. New-added
6. We suggest offering peer support interventions, including visitation by a certified Weak for Reviewed,
peer visitor, as early as feasible and throughout the rehabilitation process. Amended
B. Perioperative Phase
7. Prior to surgery, we suggest that rehabilitation goals, outcomes, and other Weak for Reviewed,
implications be included in shared decision making about residual limb length Amended
and amputation level.
8. There is insufficient evidence to recommend one surgical amputation procedure Not Reviewed,
over another. applicable New-added
9. We suggest the use of a rigid or semi-rigid dressing to promote healing and early Weak for Reviewed,
prosthetic use as soon as feasible post-amputation in transtibial amputation. Amended
Rigid post-operative dressings are preferred in situations where limb protection is
a priority.
10. We suggest performing cognitive screening prior to establishing rehabilitation Weak for Reviewed,
goals, to assess the patient’s ability and suitability for appropriate prosthetic New-replaced
technology.
11. We suggest that in the perioperative phase following amputation, patients Weak for Reviewed,
receive physical rehabilitation and appropriate durable medical New-replaced
equipment/assistive technology.
12. We suggest, when applicable, treatment in an acute inpatient rehabilitation Weak for Reviewed,
program over a skilled nursing facility. New-replaced
13. We suggest the initiation of mobility training as soon as feasible post-amputation. Weak for Reviewed,
In appropriate patients, this may include ipsilateral side weight-bearing New-replaced
ambulation with a pylon to improve physical function and gait parameters.
1 See the VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. Available at:
http://www.healthquality.va.gov/guidelines/Pain/cot/

# Recommendation Strength* Category†

14. We recommend instituting rehabilitation training interventions, using both open Strong for Reviewed,
and closed chain exercises and progressive resistance to improve gait, mobility, New-replaced
strength, cardiovascular fitness and activities of daily living performance in order
to maximize function.
C. Pre-Prosthetic Phase
15. We suggest offering microprocessor knee units over non-microprocessor knee units Weak for Reviewed,
for ambulation to reduce risk of falls and maximize patient satisfaction. There is New-added
insufficient evidence to recommend for or against any particular socket design,
prosthetic foot categories, and suspensions and interfaces.
D. Prosthetic Training Phase
16. We recommend the use of valid, reliable, and responsive functional outcome Strong for Reviewed,
measures, including, but not limited to, the Comprehensive High-level Activity New-replaced
Mobility Predictor, Amputee Mobility Predictor, 10-meter walk test, and
6-minute walk test.
17. We suggest the use of a combination of measures with acceptable psychometric Weak for Reviewed,
properties to assess functional outcomes. New-replaced
18. We recommend an assessment of factors that are associated with poorer Strong for Reviewed,
outcomes following acquired limb loss, such as smoking, comorbid injuries or Amended
illnesses, psychosocial functioning, and pain.
*For additional information, please refer to Grading Recommendations.
†For additional information, please refer to Recommendation Categorization and Appendix C.

III. Background
A. Description of Lower Limb Amputation
a. Dysvascular Amputation
In civilian and elderly VA populations, the most common cause of LLA is dysvascular complications from
diabetes, arteriosclerosis, smoking, or a combination of these. In these patients, amputation may occur
when medical or revascularization options do not exist or have failed, when significant tissue loss has
occurred, or when infectious complications can only be managed by surgical interventions.[2] In diabetic
patients, protective and prophylactic foot care and early detection of any deformity or skin breakdown
may prevent the development of ulcers and reduce the risk of amputation (see the VA/DoD CPG for the
Management of Diabetes Mellitus in Primary Care).2 Smoking cessation and control of cardiovascular risk
factors, including glycemic control in diabetics, are additional approaches to the prevention of LLA.
Due to the systemic nature of arteriosclerosis and diabetes, patients with these conditions are at high risk
for further complications to their amputated residual limb and/or amputation of the contralateral limb. In
addition, they are at higher risk for other health problems such as cardiovascular disease, cerebrovascular
accident, renal disease, peripheral neuropathy, etc. While this guideline focuses on rehabilitation of
patients with LLA, preservation of the residual and contralateral limb, as well as the patients’ general
health, wellness, and functional independence remain integral parts of ongoing care.[3]
b. Traumatic Amputation
Trauma is another major cause of LLA, though not as common as dysvascular amputations.[4] Traumatic
amputation may occur from a variety of causes, including motor vehicle and industrial accidents, electrical,
chemical and thermal burns, and injuries associated with power tool or heavy machinery use.[5] Of
particular concern to military and Veteran populations are amputations associated with combat-related
injuries, such as those occurring from explosions, penetrating, or crush injuries. These injuries are also
typically complicated by a multitude of other comorbid conditions (e.g., traumatic brain injury, post-
traumatic stress, other soft tissue injuries).[4]
c. Other Causes of Amputation

Other less prevalent causes of amputation include malignant musculoskeletal tumors, infection, iatrogenic
complications of vascular access procedures for other medical problems, and congenital limb development
deficiency. The goal in treating musculoskeletal tumors with the lowest risk of recurrence is to remove the
tumor and salvage the limb, while for tumors with high risk of local recurrence or metastasis, amputation
is often indicated. Treatment of infection may require amputation when the initial treatment leads to
vessel occlusion and extremity necrosis.[5] Chronic or recurring infection after total knee arthroplasty may
also lead to transfemoral amputation.[6] Congenital limb deficiencies account for a small percentage of
lower limb loss. Depending on the location of the deficiency, definitive amputation is performed at a time
that considers skeletal growth, while also supporting physical, behavioral, and psychological
development.[4]
2 See the VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus in Primary Care. Available at:
http://www.healthquality.va.gov/guidelines/CD/diabetes/

d. Limb Salvage and Delayed Amputation

For severe limb injury, patients and surgeons are often faced with the decision between amputation
versus limb reconstruction and salvage. While limb salvage may initially be the therapeutic option of
choice, complications such as infection, chronic pain, or persistent dysfunction may result in delayed
amputation. In some cases, the decision to attempt limb salvage may result in increased complication
rates, increased pain, and more procedures than if a primary amputation had been performed.[5] To
mitigate these risks, several scoring systems have been developed to assist with the decision to amputate
or salvage the limb. Unfortunately, these systems may not accurately predict functional recovery and,
therefore, should be used in combination with other criteria, including patient preferences.[7]
Unsuccessful attempts at limb salvage may result in increased morbidity and mortality. One study showed
that there were a greater number of hospitalization days (49.8 days versus 24.3 days) and more operative
procedures (6.7 procedures versus 1.6 procedures) for individuals who underwent delayed versus primary
amputation surgery.[8] Additionally, a retrospective cohort study of 324 Service Members with combat-
related amputations secondary to injuries sustained in Afghanistan or Iraq demonstrated better functional
outcomes compared to those with limb salvage.[9]
B. Epidemiology and Impact

Each day, more than 500 individuals in the United States (U.S.) undergo amputation, and there are more
than two million people in the U.S. living with upper or lower limb loss.[10] It is projected that there will be
3.6 million people living with upper or lower limb loss in the U.S. by 2050.[11]
e. Epidemiology of Non-Traumatic Amputation

Non-traumatic amputations due to diabetes mellitus and other disease processes have been increasing in
the U.S. in recent decades. The Centers for Disease Control and Prevention (CDC) reported that the
number of LLAs among diabetic patients increased from 55,000 in 1988 to 83,000 in 1997, then started to
decrease again to 68,000 in 2009.[12]
An analysis of Medicare data from 2000 through 2008 showed that mortality rates were nearly twice as
high for those with peripheral artery disease who had major LLA compared to similar patients that did not
have LLA at 30 days (13.5% versus 6.9%), one year (48.3% versus 24.2%), and three years (70.9% versus
43.2%).[13] Age, history of heart failure, renal disease, cancer, and chronic obstructive pulmonary diseases
were all independently associated with death after major LLA. Evidence also suggests that individuals with
more proximal limb loss (transfemoral) have a higher risk of death compared to those with more distal
locations.[13] In addition to diabetes and peripheral artery disease, it is estimated that cancers causing
non-traumatic amputation account for less than 1% of amputations in the U.S.[11]
f. Epidemiology of Traumatic Amputation

There are approximately 30,000-40,000 injury-related amputations performed in the U.S. annually.[11] An
analysis of the National Trauma Databank of civilian amputations indicated that in the U.S. from 2000-
2004, traumatic LLAs were more common than upper limb amputation (59% versus 41%). Most
amputations were caused by blunt injury (83%); 51% of those cases were caused by motor vehicle
accidents and 19.4% caused by machinery accidents. Motorcyclists and pedestrians were more likely to

sustain LLA, while those involved with motor vehicle collisions were more likely to sustain upper limb
amputation.[14]
C. Lower Limb Amputation in the Department of Veterans Affairs and the

Department of Defense
a. Department of Veterans Affairs
Similar to civilian populations, the number of individuals with amputation(s) cared for in the VA and DoD
medical systems has been increasing. Within five years of military separation, 99% of Service Members
with combat-related amputations had transitioned their care to the VA.[15] The total number of Veterans
with amputations being seen at VA facilities increased from 25,000 in fiscal year (FY) 2000 to almost 90,000
in FY 2016.[16] Annually, the number of patients undergoing an amputation procedure (of all levels,
including digit amputations of both upper and lower extremities) increased from 5,270 in FY 2001 to 6,386
in FY 2015. Although some of this growth can be attributed to an increased number of combat injuries, the
majority resulted from vascular disease; in FY 2015, 80% of patients undergoing amputation had diabetes
compared to 75% in FY 2001. Many patients required multiple procedures; during the years 2010-2015, an
average of 6,262 patients underwent an average of 9,205 amputation procedures.[17] To expand the care
and treatment of Veteran patients at risk of primary or secondary limb loss, the Prevention of Amputation
for Veterans Everywhere program was designed to help prevent or delay limb loss.3
b. Department of Defense
The Extremity Trauma and Amputation Center of Excellence database provided data on all conflict-related
amputations (excluding fingers, thumbs, or toes) sustained by U.S. Service Members between January 1,
2001 and December 31, 2016. During this period, 1,710 patients (including 28 women) sustained at least
one amputation. The majority of these amputations (73%) were a result of an improvised explosive device
blast injury. Among the 1,710 patients who underwent an amputation, 84% involved the lower limb (76%
one lower limb, 8% both lower limbs). Among the 1,574 lower limb amputation performed in these 1,439
patients, 56% were transtibal and 38% were transfemoral.[18]
Of the 1,710 Service Members who sustained a combat-related limb amputation from 2001 through 2016,
31% sustained amputations of more than one major limb.[18] While previous reports indicate the unique
challenges associated with the rehabilitation of individuals with multiple limb loss, limited published
reports exist to inform evidence-based decisions; therefore this CPG does not specifically address the care
of individuals with multiple limb loss. The reader is referred to the textbook, “Care of the Combat
Amputee,” for more information about rehabilitation for patients with multiple limb loss.[19]
D. Factors Affecting Rehabilitation of Lower Limb Amputation

The successful rehabilitation of patients with LLA is influenced by a variety of factors that include, but are
not limited to, level of amputation, cognitive impairment, physical conditioning, social support,
comorbidities, and psychological factors.[20] Amputations caused by vascular disease generally occur in
aging populations with numerous other comorbidities such as cardiovascular disease, hypertension, renal
3 See Veterans Health Administration Directive 1410, Prevention of Amputation in Veterans Everywhere. Available at:
https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364

disease, and arthritis.[13] To maximize functional outcomes and help patients reach their goals, these
factors must be considered when developing individualized rehabilitation plans for Veterans or Service
Members with LLA.
While the pathophysiology of traumatic amputations may be different than non-traumatic amputations,
rehabilitation strategies and prosthetic component prescriptions for both should be focused on realistic
patient goals with concentrated efforts directed to maximize functional recovery. The overall goals of
rehabilitation after amputation are to optimize the patient’s health status, functional independence, and
quality of life.[21,22] Ongoing assessments and therapeutic interventions to address medical, psychosocial,
physical, and functional limitations are necessary to achieve these desired outcomes.
IV. About this Clinical Practice Guideline

This guideline is intended to help improve the rehabilitative care of individuals with LLA in the VA and DoD
systems. It is intended for VA and DoD healthcare practitioners including physicians (e.g., physiatrists,
surgeons, primary care, podiatrists), prosthetists, physical therapists, occupational therapists, nurse
practitioners, physician assistants, psychologists, social workers, nurses, and others involved in the care of
Service Members or Veterans with LLA.
As with other CPGs, challenges remain with guideline development and the implementation and
assessment of the eventual impact the guidelines will have on clinical outcomes. Principal limitations in
forming comprehensive CPGs include existing gaps in clinical evidenced-based research that demonstrate
sufficient efficacy of interventions. As elaborated in the qualifying statement on page one, this CPG is not
intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data
available for an individual patient and are subject to change as scientific knowledge and technology
advance and patterns evolve. This CPG is based on evidence available through July 2016 and is intended to
provide a general guide to best practices. The guideline can assist care providers, but the use of a CPG
must always be considered as a recommendation, within the context of a provider’s clinical judgment and
patient values and preferences, for the care of an individual patient.
A. Methods
The current document is an update to the 2007 VA/DoD LLA CPG. The methodology used in developing the
2017 CPG follows the Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The
Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This
document provides information regarding the process of developing guidelines, including the identification
and assembly of the Guideline Champions (Champions) and other subject matter experts from within the
VA and DoD, known as the Work Group, and ultimately, the development and submission of an updated
LLA CPG.
The Champions and Work Group for this CPG were charged with developing evidence-based clinical
practice recommendations and writing and publishing a guideline document to be used by providers
within the VA/DoD healthcare systems. Specifically, the Champions and Work Group members for this
guideline were responsible for identifying the key questions (KQs) of the most clinical relevance,
importance, and interest for the rehabilitation of LLA. The Champions and the Work Group also provided

direction on inclusion and exclusion criteria for the evidence review and assessed the level and quality of
the evidence. The amount of new scientific evidence that had accumulated since the previous version of
the CPG was also taken into consideration in the identification of the KQs. In addition, the Champions
assisted in:
• Identifying appropriate disciplines of individuals to be included as part of the Work Group
• Directing and coordinating the Work Group
• Participating throughout the guideline development and review processes
The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S.
Army Medical Command, the proponent for CPGs for the DoD, identified five clinical leaders, Billie
Randolph, PhD, PT, and Joseph Webster, MD from the VA and Andrea Crunkhorn, DPT, LTC Keith Myers,
MD, and Paul Pasquina, MD from the DoD, as Champions for the 2017 CPG.
The Lewin Team, including The Lewin Group, Duty First Consulting, ECRI Institute, and Sigma Health
Consulting, LLC, was contracted by the VA and DoD to support the development of this CPG and conduct
the evidence review. The first conference call was held in March 2016, with participation from the
contracting officer’s representative, leaders from the VA Office of Quality, Safety and Value and the DoD
Office of Evidence Based Practice, and the Champions. During this call, participants discussed the scope
of the guideline initiative, the roles and responsibilities of the Champions, the project timeline, and the
approach for developing and prioritizing specific research questions on which to base a systematic
review (SR) about the rehabilitation of LLA. The group also identified a list of clinical specialties and
areas of expertise that are important and relevant to rehabilitation of individuals with LLA, from which
Work Group members were recruited. The specialties and clinical areas of interest included: physical
therapy, occupational therapy, physical medicine and rehabilitation, nursing, pain medicine, psychology,
and prosthetics.
The guideline development process for the 2017 CPG update consisted of the following steps:
1. Formulating and prioritizing evidence questions (KQs)
2. Conducting the SR
3. Convening a face-to-face meeting with the CPG Champions and Work Group members
4. Drafting and submitting a final CPG to the VA/DoD EBPWG
Appendix A provides a detailed description of each of these tasks.
a. Grading Recommendations
The Champions and Work Group used the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) system to assess the quality of the evidence base and assign a grade for the strength
for each recommendation. The GRADE system uses the following four domains to assess the strength of
each recommendation:[23]
• Balance of desirable and undesirable outcomes
• Confidence in the quality of the evidence

• Patient or provider values and preferences

• Other implications, as appropriate, e.g.,:
 Resource use
 Equity
 Acceptability
 Feasibility
 Subgroup considerations
Using this system, the Champions and Work Group determined the relative strength of each
recommendation (Strong or Weak). A strong recommendation indicates that the Work Group is highly
confident that desirable outcomes outweigh undesirable outcomes. If the Work Group is less confident of
the balance between desirable and undesirable outcomes, they give a weak recommendation.
They also determined the direction of each recommendation (For or Against). Similarly, a recommendation
for a therapy or preventive measure indicates that the desirable consequences outweigh the undesirable
consequences. A recommendation against a therapy or preventive measure indicates that the undesirable
consequences outweigh the desirable consequences.
Using these elements, the grade of each recommendation is presented as part of a continuum:
• Strong For (or “We recommend offering this option …”)
• Weak For (or “We suggest offering this option …”)
• Weak Against (or “We suggest not offering this option …”)
• Strong Against (or “We recommend against offering this option …”)
The grade of each recommendation made in the 2017 CPG can be found in the section on
Recommendations. Additional information regarding the use of the GRADE system can be found in
Appendix A.
b. Reconciling 2007 Clinical Practice Guideline Recommendations

Evidence-based CPGs should be current, which typically requires revisions of previous guidelines based
on new evidence, or as scheduled, subject to time-based expirations.[24] For example, the U.S.
Preventive Services Task Force (USPSTF) has a process for refining or otherwise updating its
recommendations pertaining to preventive services.[25] Further, the inclusion criteria for the National
Guideline Clearinghouse specify that a guideline must have been developed, reviewed, or revised within
the past five years.
The LLA Guideline Work Group focused largely on developing new and updated recommendations based
on the evidence review conducted for the priority areas addressed by the KQs. In addition to those new
and updated recommendations, the CPG Work Group considered, without complete review of the relevant
evidence, the current applicability of other recommendations that were included in the previous 2007 LLA
CPG, subject to evolving practice in today’s environment.

A set of recommendation categories was adapted from those used by the National Institute for Health
and Care Excellence (NICE).[26,27] These categories, along with their corresponding definitions, were
used to account for the various ways in which older recommendations could have been updated. In
brief, the categories took into account whether or not the evidence that related to a recommendation
was systematically reviewed, the degree to which the recommendation was modified, and the degree to
which a recommendation is relevant in the current patient care environment and inside the scope of the
CPG. Additional information regarding these categories and their definitions can be found in Appendix A.
The categories for the recommendations included in the 2017 version of the guideline can be found in
the section on Recommendations. The categories for the recommendations from the 2007 LLA CPG are
noted in Appendix C.
The CPG Work Group recognized the need to accommodate the transition in evidence rating systems from
the 2007 LLA CPG to the current CPG. In order to report the strength of all recommendations using a
consistent format (i.e., the GRADE system) the CPG Work Group converted the USPSTF strengths of the
recommendation accompanying the carryover recommendations from the 2007 guideline to the GRADE
system. As such, the CPG Work Group considered the strength of the evidence cited for each
recommendation in the 2007 LLA CPG as well as harms and benefits, values and preferences, and other
implications, where possible. The CPG Work Group referred to the available evidence as summarized in
the body of the 2007 LLA CPG and did not re-assess the evidence systematically. In some instances, peer-
reviewed literature published since the 2007 LLA CPG was considered along with the evidence base used
for that CPG. Where such newer literature was considered when converting the strength of the
recommendation from the USPSTF to the GRADE system, it is referenced in the discussion that follows the
corresponding recommendation, as well as in Appendix B.
The CPG Work Group recognizes that, while there are practical reasons for incorporating findings from a
previous evidence review, previous recommendations,[28] or recent peer-reviewed publications into an
updated CPG, doing so does not involve an original, comprehensive SR and, therefore, may introduce bias.
It is important to note that the 2007 LLA CPG based many recommendations on expert opinion alone and
were therefore not considered to be evidence-based. While the USPSTF grading system allows for
recommendations to be based on expert opinion alone, the GRADE system does not. Therefore, while the
2017 CPG Work Group recognized that many of the 2007 recommendations based on expert opinion alone
contained valuable clinical concepts, these 2007 recommendations were not carried forward to this
guideline update. However, some of these clinical concepts are discussed in the guideline narrative.
c. Peer Review Process

The CPG was developed through an iterative process in which the Work Group produced multiple drafts of
the CPG. The process for developing the initial draft is described in more detail in Drafting and Submitting
the Final Clinical Practice Guideline.
Once a near-final draft of the guideline was agreed upon by the Champions and Work Group members, the
draft was sent out for peer review and comment. The draft was posted on a wiki website for a period of 14
business days. The peer reviewers comprised individuals working within the VA and DoD health systems as

well as experts from relevant outside organizations designated by the Work Group members. External
organizations who participated in the peer review included the following:
• Amputee Coalition
• Human Engineering Research Laboratories, University of Pittsburgh
• National Center for Medical Rehabilitation Research, National Institutes of Health
The VA and DoD Leadership reached out to both the internal and external peer reviewers to solicit their
feedback on the CPG. Reviewers were provided a hyperlink to the wiki website where the draft CPG was
posted. For transparency, all reviewer feedback was posted in tabular form on the wiki site, along with
the name of the reviewer. All feedback from the peer reviewers was discussed and considered by the
Work Group. Modifications made throughout the CPG development process were made in accordance
with the evidence.
B. Summary of Patient Focus Group Methods and Findings

When forming guideline recommendations, consideration should also be given to the values of the
patients, who will likely be most affected by the recommendations. Patients bring perspectives, values,
and preferences into their healthcare experience, which may vary from those of clinicians. These
differences can affect decision making in various situations, and should thus be highlighted and made
explicit due to their potential to influence a recommendation’s implementation.[29,30] Focus groups
can be used as an efficient method to explore ideas and perspectives of a group of individuals with an a
priori set of assumptions or hypotheses and collect qualitative data on a thoughtfully predetermined set
of questions.
Therefore, as part of the effort to update this CPG, VA and DoD Leadership, along with the LLA CPG Work
Group, held a patient focus group prior to finalizing the KQs for the evidence review. The group met on
May 24, 2016, at Walter Reed National Military Medical Center in Bethesda, Maryland. The aim of the
focus group was to further the understanding of the perspectives of patients with LLA undergoing
rehabilitation within the VA and/or DoD healthcare systems. The focus group explored a set of topics
related to rehabilitation after LLA including knowledge of rehabilitation options, delivery of care, and the
impact of and challenges related to LLA.
It is important to note the focus group was a convenience sample and the Working Group recognizes the
limitations inherent in the small sample size. Less than 10 people were included in the focus group
consistent with the requirements of the federal Paperwork Reduction Act, 1980. The Work Group
acknowledges that the sample of patients included in this focus group may not be representative of all VA
and DoD patients undergoing rehabilitation for LLA. The patient perspective and input provided, while
invaluable, is not generalizable given the broad characteristics of various key demographic groups of
persons with LLA. Further, time limitations for the focus group prevented exhaustive exploration of all
topics related to rehabilitation and the patients’ broader experiences with their care. Thus, the Work
Group made decisions regarding the priority of topics to discuss at the focus group. These limitations, as
well as others, were considered throughout the use of the information collected from the discussion for
guideline development.

Recruitment for participation in the focus group was managed by the Champions and VA and DoD
Leadership, with assistance from coordinators at the facility where the focus group took place.
The following concepts are ideas and suggestions about aspects of care that are important to patients and
family caregivers that emerged from the discussion. These concepts were needed and important parts of
the participants’ care and added to the Work Group’s understanding of patient values and perspectives.
The Work Group considered the focus group feedback while assessing the strength of each
recommendation and continued to consider the feedback throughout the LLA CPG development process.
Additional details regarding the patient focus group methods and findings can be found in Appendix E.
LLA CPG Patient Focus Group Concepts

A. Recognize the importance of a transdisciplinary amputation care team and the necessity for patients to have a
trusting relationship with their prosthetist.
B. Consider patient-specific goals, values, and preferences and use shared decision making to develop a
rehabilitation plan.
C. Address strategies for pain and medication management across all phases of the rehabilitation process.
D. Involve family caregivers and leverage peer networks to create support and motivation for patients with lower
limb amputations.
E. Consider unique challenges faced by different patient populations (e.g., females) during rehabilitation.
F. Work with providers to ensure continuity of care and ease of access to preferred providers and prescriptions.
C. Conflict of Interest
At the start of this guideline development process and at other key points throughout, the project team
was required to submit disclosure statements to reveal any areas of potential conflict of interest (COI) in
the past 24 months. Verbal affirmations of no COI were used as necessary during meetings throughout the
guideline development process. The project team was also subject to random web-based surveillance (e.g.,
ProPublica).
If a project team member reported a COI (actual or potential), then it was reported to the Office of
Evidence Based Practice. It was also discussed with the LLA CPG Work Group in tandem with their review
of the evidence and development of recommendations. The Office of Evidence Based Practice and the LLA
CPG Work Group determined whether or not action, such as restricting participation and/or voting on
sections related to the conflict or removal from the Work Group, was necessary. If it was deemed
necessary, action was taken by the co-chairs and Office of Evidence Based Practice, based on the level and
extent of involvement. No conflicts of interest were identified for the LLA CPG Work Group members or
Champions. Disclosure forms are on file with the Department of Veterans Affairs Evidence Based Practice
Program office and available upon request.
D. Scope of this Clinical Practice Guideline

Regardless of setting, any patient in the healthcare system should be offered access to the interventions
that are recommended in this guideline after taking into consideration the patient’s specific circumstances.
Guideline recommendations are intended to be patient centered. Thus, treatment and care should take
into account a patient’s needs and preferences. Good communication between healthcare professionals
and the patient is essential and should be supported by evidence-based information tailored to the

patient’s needs. Use of an empathetic and non-judgmental approach facilitates discussions sensitive to
gender, culture, and ethnic differences. The information that patients are given about treatment and care
should be culturally appropriate and also available to people with limited literacy skills. It should also be
accessible to people with additional needs such as physical, sensory, or learning disabilities. Family
involvement should be considered, if appropriate.
This CPG is designed to assist providers in managing or co-managing patients in rehabilitation for LLA.
Moreover, the patient population of interest for this CPG is adults who are eligible for care within the VA
and DoD healthcare delivery systems. It includes Veterans as well as deployed and non-deployed Active
Duty Service Members and their adult beneficiaries. This CPG does not provide recommendations for
rehabilitation of children or adolescents with LLA.
The literature review encompassed interventional studies (primarily randomized controlled trials [RCTs])
as well as observational studies, and diagnostic tests studies published between January 2007 and June
2016, and targeted 10 KQs focusing on the means by which the delivery of healthcare could be
optimized for patients during rehabilitation of LLA. The selected KQs (see Table A-4) were prioritized by
the Work Group from many possible KQs based on consensus as to their level of importance. Due to
resource constraints, an extensive review of the evidence in all important aspects of care was not
feasible for the update to this CPG.
E. Highlighted Features of this Clinical Practice Guideline

This 2017 edition of the VA/DoD LLA CPG is the first update to the original CPG. It provides practice
recommendations for the care of populations undergoing rehabilitation for individuals with LLA. A
particular strength of this CPG is the transdisciplinary stakeholder involvement from its inception, ensuring
representation from the broad spectrum of clinicians engaged in rehabilitation of patients with LLA.
The framework for recommendations in this CPG considered factors beyond the strength of the evidence,
including balancing desired outcomes with potential harms of treatment, equity of resource availability,
and the potential for variation in patient values and preferences. Applicability of the evidence to VA/DoD
populations was also taken into consideration. A structured algorithm accompanies the guideline to
provide an overview of the recommendations in the context of the flow of patient care and clinician
decision making and to assist with training providers. The algorithm may be used to help facilitate
translation of guideline recommendations into effective practice.

This guideline is designed to address the key principles of rehabilitation and clinical care for patients with
LLA. This CPG highlights the following goals to ensure quality care:
• Promote a patient-centered transdisciplinary team approach
• Address key aspects of the rehabilitation process that is focused on maximizing the patient’s
functional independence and quality of life, including: prosthetic selection and fitting, activities
of daily living (ADL) and instrumental ADL training with and without a prosthesis, promoting
physical conditioning, and optimizing pain and medication management
• Develop recommendations that are consistent with current evidence-based rehabilitation
methods
• Provide rehabilitation care providers with an algorithm of appropriate rehabilitation
interventions to improve the patient outcomes and reduce practice variation
• Provide primary care providers an algorithm to assist with the referral process
• Establish priorities for future research that will generate evidence for practice improvement
F. Patient-centered Care
VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is individualized based on
patient capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all
patients in the healthcare system should be offered access to evidence-based interventions appropriate to
that patient. When properly executed, patient-centered care (PCC) may decrease patient anxiety, increase
trust in clinicians,[31] and improve treatment adherence.[32] Improved patient-clinician communication
through PCC can be used to convey openness to discuss any future concerns.
As part of the PCC approach, clinicians should review the outcomes of past rehabilitation experiences and
outcomes of possible future treatments with the patient. Additionally, they should involve the patient in
prioritizing rehabilitation goals and setting specific goals regardless of the selected setting or level of care.
G. Shared Decision Making

Throughout this VA/DoD CPG, the authors encourage clinicians to focus on shared decision making (SDM).
The SDM model was introduced in 2001 Crossing the Quality Chasm, a National Academy of Medicine
(formerly the Institute of Medicine) report.[33] It is readily apparent that patients with LLA, together with
their clinicians, make decisions regarding the level of rehabilitation they choose to engage in; however,
these patients require sufficient information to be able to make informed decisions. Clinicians must be
adept at presenting information to their patients regarding individual rehabilitation plans and appropriate
locations of care.
H. Implementation
This CPG and algorithm are designed to be adapted by individual healthcare providers with consideration
of local needs and resources. The algorithm serves as a tool to prompt providers to consider key decision
points in the course of an episode of care.
Although this CPG represents the recommended practice on the date of its publication, medical practice is
evolving and this evolution requires continuous updating based on published information. New technology

and more research will improve patient care in the future. The CPG can assist in identifying priority areas
for research and to inform optimal allocation of resources. Future studies examining the results of CPG
implementation may lead to the development of new evidence particularly relevant to clinical practice.

V. Guideline Work Group

Guideline Work Group*
Department of Veterans Affairs Department of Defense
Billie Randolph, PT, PhD (Champion) Andrea Crunkhorn, DPT (Champion)
Joseph Webster, MD (Champion) LTC Keith P. Myers, MD (Champion)
M. Jason Highsmith, PT, DPT, PhD, CP, FAAOP Paul Pasquina, MD (Champion)
Martin McDowell, L/CPO, LPO Lisa D. Jones, RN, BSN, MHA, CPHQ
Leif Nelson, PT, DPT, ATP, CSCS Louise Hassinger, CP
Aaron Turner, PhD MAJ John P. McCallin, MD, FAAPMR
Deb Velez, RN, MN, GNP-BC Kelly McGaughey, PT, DPT
Patty Young, MSPT, CP Joseph A. Miller, PhD, MS, CP
LCDR Lynita Mullins, DO
Annemarie Orr, OTD, OTR/L
LTC Benjamin K. Potter, MD
Alison Pruziner, PT, DPT, ATC
Office of Quality, Safety and Value Office of Evidence Based Practice
Veterans Health Administration U.S. Army Medical Command
Eric Rodgers, PhD, FNP, BC
Corinne K. B. Devlin, MSN, RN, FNP-BC
James Sall, PhD, FNP-BC
Lisa D. Jones, RN, BSN, MHA, CPHQ
Rene Sutton, BS, HCA
Lewin Group ECRI Institute
Clifford Goodman, PhD James Reston, MPH, PhD
Christine Jones, MS, MPH, PMP Jeff Oristaglio, PhD
Jacqlyn Witmer Riposo, MBA Amy Tsou, MD
Nicolas Stettler-Davis, MD, MSCE Marna Johnston, MLIS
Sigma Health Consulting, LLC DutyFirst Consulting
Anita Ramanathan, BA
Frances Murphy, MD, MPH
Megan McGovern, BA
*Additional contributor contact information is available in Appendix D.

VI. Algorithm
This CPG includes an algorithm which is designed to facilitate understanding of the clinical pathway and
decision-making process used in rehabilitation of patients with LLA. The use of the algorithm format as a
way to represent patient management was chosen based on the understanding that such a format may
promote more efficient diagnostic and therapeutic decision making and has the potential to change
patterns of resource use. Recognizing that some clinical care processes are non-linear, the algorithm
format allows the provider to follow a simplified linear approach in assessing the critical information
needed at the major decision points in the clinical process, and includes:
• An ordered sequence of steps of care
• Recommended observations and examinations
• Decisions to be considered
• Actions to be taken
A clinical algorithm diagrams a guideline into a step-by-step decision tree. Standardized symbols are used
to display each step in the algorithm, and arrows connect the numbered boxes indicating the order in
which the steps should be followed.[34]

Module A: Transdisciplinary Amputation Care Team Approach (TACT)

Module B: Primary Care Follow-up and Lifelong Care

VII. Discussion of Recommendations

A. All Phases of Amputation Rehabilitation
Recommendation
1. We suggest that patient education be provided by the rehabilitation care team throughout all
phases of amputation rehabilitation.
(Weak for | Reviewed, Amended)
Discussion
It is difficult to assess the relative effectiveness of different educational strategies, because multiple
strategies are often “packaged” as one intervention and outcome measures may lack the sensitivity or
specificity to detect the outcome of interest. Confidence in the quality of evidence from the 2007 LLA
CPG is moderate to low in support of patient education pre- or post-amputation surgery.[35,36] Despite
the moderate to low quality of the evidence, the benefits of providing patient education throughout all
phases of amputation rehabilitation greatly outweigh the potential harms to the patient. Education is
also valuable to patients, who generally prefer that providers use an SDM approach to develop their
rehabilitation plan. Indeed, patient focus group members stressed the need for using an SDM model to
develop a rehabilitation plan.
Care and education for the patient with amputation (traumatic and non-traumatic) is complex and
requires multiple medical, surgical, and rehabilitation specialties. A transdisciplinary approach that creates
a holistic technique, utilizing concepts or methods of multiple disciplines, is vital to LLA rehabilitation. In
addition to the patient, members of the medical rehabilitation team may include the patient’s support
system, surgeon, physiatrist, physical therapist, occupational therapist, recreational therapist, prosthetist,
nurse, social worker, behavioral health specialist, peer support visitors, and case manager. Topics on which
clinicians should provide clear advice and information include but are not limited to: surgical interventions,
residual limb length, amputation level, rehabilitation programs, prosthetic options, and possible outcomes
with realistic rehabilitation goals in order for patients to make informed decisions regarding their
care.[21,22]
The Joint Commission (JC) recognizes the importance of patient education in influencing the patient’s
outcome and in promoting healthy behaviors. The JC requires that the patient’s learning needs be
assessed by all disciplines involved in the care of the patient and that coordinated education and training
be provided to the patient based upon those needs.[37] Table 1 provides some of the JC’s patient
education performance elements for patient education. The Commission on the Accreditation of
Rehabilitation Facilities (CARF) also specifies patient educational requirements for Amputation Specialty
Care Programs.[38] The concept of patient self-management may also require the assistance and support
of external resources such as the Amputee Coalition.[39] Information on these resources should be made
available to patients.
Once the patient’s educational needs and preferred delivery method are identified, a plan should be
implemented using appropriate verbal, written, and hands-on learning methods. All aspects of the
patient education process should be documented in the patient’s medical record throughout the
continuum of care.

Table 1. Joint Commission’s Performance Elements for Patient Education[37]

Patient Education Regarding Rehabilitation Techniques
Based on the patient’s condition and assessed needs, the education and training provided to the patient
by the organization include the following:
 An explanation of the plan for care, treatment, or services
 Basic health practices and safety including information on the safe and effective use of medications,
nutrition interventions, and modified diets
 Discussion of pain, the risk for pain, the importance of effective pain management, the pain
assessment process, and methods for pain management
 Information on the safe and effective use of medical equipment or supplies
 Habilitation or rehabilitation techniques to help the patient reach maximum independence
Recommendation
2. We suggest an assessment of behavioral health and psychosocial functioning at every phase of
amputation management and rehabilitation.
Discussion
The LLA Work Group advocates for assessment of behavioral health and psychosocial functioning
throughout rehabilitation based on the original evidence referenced in the 2007 CPG,[40-43] the support
of two additional studies, including one RCT,[44,45] and the consideration that the potential benefit to the
patient far outweighs potential harm. Additionally, patient focus group participants expressed a desire to
have individualized mental health care treatment throughout their rehabilitation.
Behavioral health includes mental health diagnoses commonly occurring in individuals with limb loss,
including depression, anxiety, and posttraumatic stress disorder (PTSD). Psychosocial functioning refers to
the patient’s ability to manage the psychological and social factors which influence his/her interpersonal
relationships, and personally meaningful activities such as work and school. In the case of a patient with
LLA, this also refers to how well the patient is able to participate in these activities despite his or her
physical impairment. Evidence from the 2007 LLA CPG identified depression, anxiety, and posttraumatic
stress as common behavioral health symptoms in individuals with limb loss, and also that psychosocial
functioning was frequently correlated with aspects of limb loss (e.g., etiology, time since amputation).[40-
43]
Subsequently, one large multi-site RCT examining an intervention to improve self-management following
limb loss (including sessions devoted to developing coping strategies for mood, positive health behavior,
enlisting social support, and engaging with community resources) found that self-management training
improved behavioral health symptoms (depression) as well as functional limitations.[44] An additional
cross-sectional quantitative study of 106 patients with LLA in 2015 found that problem-focused coping
strategies and avoidance of emotion-focused coping strategies were significant correlates of posttraumatic
growth following an amputation.[45] The problem-focused strategies noted were religious belief,
acceptance, positive reframing, planning, and active coping.
Periodic assessments of the patient should include inquiries into behavioral health status and psychosocial
functioning (including spiritual beliefs and coping mechanisms). These assessments should be repeated at

each phase of care, and should be part of long-term management. For patients at risk for suicide, 4 major
depressive disorder, 5 PTSD and acute stress reaction, 6 or substance use disorder, 7 see the relevant
VA/DoD CPGs.
Recommendation
3. When assessing pain, we suggest that measurement of the intensity of pain and interference with
function should be separately assessed for each pain type and location using standardized tools.
Discussion
Pain management post-amputation is of utmost importance in promoting enhanced recovery, higher
patient satisfaction, and lower cost of care. While pain is a subjective and individual experience, it should
be assessed with standardized and validated tools when possible. Moderate confidence in the quality of
evidence referenced in the 2007 LLA CPG exists to support continuous assessment of pain throughout the
perioperative and rehabilitation period in individuals with LLA and that this assessment should include
characteristics such as location, intensity, character, duration, timing, and aggravating factors or
triggers.[46] These pain types include but are not limited to: residual limb pain, including neuropathic pain,
phantom limb pain (PLP), other visceral or musculoskeletal pains, as well as pre-existing pain syndromes or
comorbidities. Both pharmacological and non-pharmacological interventions should be considered and
monitored for their effectiveness and/or side effects.
Though there was limited evidence on which to assess the strength of the recommendation, the Work
Group determined that the benefits of assessing pain using standardized tools far outweigh any potential
harms to the patient, as even small improvements in pain and function can improve an individual’s quality
of life. Patient focus group participants also expressed the desire to manage their pain after surgery and
throughout all stages of rehabilitation and for providers to use an SDM approach when developing the
treatment plan.
Equally important to measuring the intensity of pain is to consider the effects of pain on a patient’s
function. Little to no improvement in the intensity of pain may be seen, but a significant improvement in
the patient’s function may be considered a successful intervention. The Defense and Veterans Pain Rating
Scale, when used with the supplemental questions that specifically measure the interference of pain on
function, uniquely provides the ability to measure both the pain intensity as well as pain’s interference on
function.
4 See the VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide. Available at:
http://www.healthquality.va.gov/guidelines/MH/srb/
5 See the VA/DoD Clinical Practice Guideline for the Management of Major Depressive Disorder (MDD CPG). Available at:
http://www.healthquality.va.gov/guidelines/MH/mdd/
6 See the VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Reaction (PTSD
CPG). Available at: http://www.healthquality.va.gov/guidelines/MH/ptsd/

7 See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorder (SUD CPG). Available at:
http://www.healthquality.va.gov/guidelines/MH/sud/

Examples of standardized tools include:

• Visual Analogue Scale[47]
• Short Form McGill Pain Questionnaire[48]
• Pain Interference Scale[49]
• Defense and Veterans Pain Rating Scale 8
Recommendation
4. We suggest offering a multi-modal, transdisciplinary individualized approach to pain management
including transition to a non-narcotic pharmacological regimen combined with physical,
psychological, and mechanical modalities throughout the rehabilitation process (For the treatment
of chronic pain, the 2017 VA/DoD CPG for the Management of Opioid Therapy for Chronic Pain
recommends alternatives to opioid therapy such as self-management strategies, other non-
pharmacological treatments, and non-opioids over opioids [see the 2017 VA/DoD OT CPG9]).
(Weak for | Reviewed, New-replaced)
Discussion
There are multiple pharmacological and non-pharmacological options for treating pain, and although the
evidence is limited, the LLA Work Group suggests that a multi-modal, individualized approach to pain
management be pursued for each patient due to the benefits for the patient.[50] Given the heterogeneity
of patient characteristics, there is likely to be variation in patient preference and response to treatments.
Frequent adjustments to interventions should be considered on an individual basis.
Pain is an individual experience that can vary based on multiple factors, including the patient’s past
medical history and experiences. All patients with LLA will likely experience some form of pain during the
course of treatment and rehabilitation. The forms of pain that may be experienced include pre- and post-
surgical pain, residual limb pain, neuropathic pain to include PLP, and other musculoskeletal pains. While
PLP and phantom limb sensation (PLS) are common after limb loss (occurring in >80% of patients), these
sensations generally improve over time and treatment should be reserved for pain that is disruptive of
function.[51]
With the exception of some evidence to support the use of perineural catheters, there is limited evidence
to support other specific pain interventions in the perioperative period.[52] Other pharmacological and
non-pharmacological interventions that have been used, but for which there is insufficient supporting
evidence, include: anticonvulsants, tricyclic antidepressants, serotonin and norepinephrine reuptake
inhibitors, nonsteroidal anti-inflammatory drugs, transcutaneous electrical nerve stimulation,
desensitization, scar mobilization, relaxation, hypnosis and biofeedback, mirror therapy, and interventional
techniques such as neuraxial and regional analgesia as well as neuromodulation to include spinal cord
stimulation. Recent evidence also suggests a potential benefit of repetitive transcranial magnetic
8 See the Defense & Veterans Pain Rating Scale. Available at: http://www.dvcipm.org/site/assets/files/1084/dvprs-front-vector.pdf

stimulation for the treatment of PLP.[53] Continued research is needed to discover and support more
effective pain management strategies, which minimize potential side effects.
There has been a recent shift in clinical practice away from long-term opioid use for chronic pain. For the
treatment of chronic pain, the 2017 VA/DoD Opioid Therapy for Chronic Pain CPG (2017 VA/DoD OT
CPG) 10 recommends alternatives to opioid therapy such as self-management strategies, other non-
pharmacological treatments, and non-opioids over opioids (see the 2017 VA/DoD OT CPG
Recommendation 1 in Table 2). It also recommends tapering to reduced dose or to discontinuation of long-
term opioid therapy when risks of long-term opioid therapy outweigh benefits, and individualizing tapering
based on risk assessment and patient needs and characteristics (see the 2017 VA/DoD OT CPG
Recommendations 14-15 in Table 2). For the acute phase, the 2017 VA/DoD OT CPG recommends
alternatives for mild-to-moderate pain, and if opioids are prescribed, it recommends “immediate-release
opioids at the lowest effective dose with reassessment no later than 3-5 days to determine if adjustments
or continuation of OT is indicated” (see 2017 VA/DoD OT CPG Recommendation 18 in Table 2). Patient
education about opioid risks and alternatives to opioid therapy should be offered. In addition to the
standard long-term effects from chronic opioid therapy, individuals with LLA may have several adverse
effects to consider. Sedation and balance issues from opioids may impede the rehabilitation progress.
Table 2: Relevant 2017 VA/DoD OT CPG Recommendations10

2017 VA/DoD
Strength of
OT CPG Recommendation
Recommendation
Recommendation #
a) We recommend against initiation of long-term opioid a) Strong against
therapy for chronic pain.
b) We recommend alternatives to opioid therapy such as b) Strong for
1 self-management strategies and other non-
pharmacological treatments.
c) When pharmacologic therapies are used, we c) Strong for
recommend non-opioids over opioids.
We recommend tapering to reduced dose or to Strong for
discontinuation of long-term opioid therapy when risks of
14 long-term opioid therapy outweigh benefits.
Note: Abrupt discontinuation should be avoided unless

required for immediate safety concerns.
We recommend individualizing opioid tapering based on Strong for
risk assessment and patient needs and characteristics.
15
Note: There is insufficient evidence to recommend for or
against specific tapering strategies and schedules.

2017 VA/DoD
Strength of
OT CPG Recommendation
Recommendation
Recommendation #
a) We recommend alternatives to opioids for mild-to- a) Strong for
moderate acute pain.
b) We suggest use of multimodal pain care including non- b) Weak for
opioid medications as indicated when opioids are used
for acute pain.
c) If take-home opioids are prescribed, we recommend c) Strong for
18 that immediate-release opioids are used at the lowest
effective dose with opioid therapy reassessment no
later than 3-5 days to determine if adjustments or
continuing opioid therapy is indicated.
Note: Patient education about opioid risks and alternatives

to opioid therapy should be offered.
Recommendation
5. We recommend providers consider the patient’s birth sex and self-identified gender identity in
developing individualized treatment plans.
(Strong for | Reviewed, New-added)
Discussion
Research supports that there are significant differences between male and female birth sex patients in
areas such as successful prosthesis fitting, time in rehabilitation, use of coping self-statements, and pain
catastrophizing.[54-56] In two studies, evidence suggests more successful prosthetic fitting for patients
with a male birth sex compared to female birth sex.[54,55] The patient focus group participants indicated
that prosthetic satisfaction depended on multiple factors, including socket comfort, function, and ability
for prosthesis to accommodate clothes and shoes, which is particularly challenging for women. Published
evidence implicates multiple factors that influence prosthetic fit, including birth sex and gender, age,
diagnosis of diabetes, and mean length of rehabilitation.[54,55] Women spent significantly more time in
rehabilitation after successful fit of a prosthetic leg than men.[55] Another study reported significantly
greater use of coping self-statements with women compared to men.[56] Although there was no
significant difference between groups reporting residual limb pain or PLP, women were significantly more
likely than men to endorse beliefs related to personal control over pain, appropriateness of solicitous
responses from others, and higher pain catastrophizing. While men and women with limb loss did not
significantly differ in their disability-specific pain, sex/gender differences in their experience of pain were
significant and worthy of future clinical attention.
Additional evidence reported that women are significantly more likely to have transfemoral amputations
compared to men.[57] The study found that women with peripheral arterial disease are at greater risk for
compromise in daily functioning, have poorer quality of life, and more often present with critical limb
ischemia and higher levels of arterial lesions, resulting in more proximal level amputation. Given that
higher levels of amputation are associated with higher metabolic costs during ambulation and greater
difficulty with socket fit, importance should be given to early and repeated screening of women with
vascular disease.

Each of these studies looked at different aspects of care and all found differences between men and
women. It is important that these issues and concerns are acknowledged and addressed as part of the
comprehensive care of each patient. It is not known if these differences are attributable to birth sex
differences or to gender-based cultural factors, thus the treatment of transgender Veterans and Service
Members should attend to risk and resilience factors associated with both their birth sex and current
gender identity.
There was moderate confidence in the evidence to support this recommendation. Confidence was
supported by multiple studies drawing similar conclusions on differences between men and women across
many areas of functioning. In this case, despite a lack of research, the benefits of addressing sex and
gender-specific needs greatly outweigh the potential harms to the patient. Evidence was supported by
other considerations, such as the patient focus group, which emphasized the importance of recognizing
patient differences and designing treatment plans according to each patient’s unique needs. The patient
focus group participants also expressed concerns regarding the need for more female-specific prosthetic
components. The size and weight of many prosthetic options that might be ideal for a man may be too
heavy or oversized for some women.
Although the majority of individuals with amputation in the U.S. are men, it is estimated that women make
up to 35% of this population.[11] As research continues to show differences among the groups, it is worth
addressing the influence of birth sex and self-identified gender identity more extensively in future
research. Many published studies have a limited number of female birth sex or transgender individuals
included in their cohorts, which limits the ability to generalize results within these populations. There is a
need to establish normative values and screening tools for these populations.
Recommendation
6. We suggest offering peer support interventions, including visitation by a certified peer visitor, as
early as feasible and throughout the rehabilitation process.
Discussion
The quality of evidence for peer support interventions is low; however, it suggests that involvement in
some type of support program can be beneficial for both the patient and the family/caregiver.[58] The
early involvement of family members and contact with other patients with amputations is important for
the patient’s psychological adjustment.[59] The CARF Amputation Specialty Program requirements are
consistent with literature suggesting that peer visits work best when the age, gender, and amputation level
are considered and matched.[38,58] Patient focus group participants reported that peer support programs
are often helpful following amputation as they provide opportunities for patients with amputation to
relate to one another as well as share experiences and coping strategies. These factors indicate that the
benefits of offering this component of care greatly outweigh the potential harms to the patient.
While initial introductory visits between a new patient and the peer visitor are best done in person, follow-
up visits can be done more easily and frequently using phone, e-mail, or text messaging. For patients who
are not a reasonable distance from a peer center, or live in an area with low population density, a clinical
video telehealth visit (real-time video conference) may also be used to broaden the patient’s access to a
certified peer visitor or support group.

While peer and other support strategies should be considered prior to and immediately following
amputation, when anxiety and adjustment problems may be more pronounced, more research is needed
to determine the optimal timing, frequency, duration, and number of peer visits needed prior to or
following amputation for positive outcomes.
B. Perioperative Phase
Recommendation
7. Prior to surgery, we suggest that rehabilitation goals, outcomes, and other implications be
included in shared decision making about residual limb length and amputation level.
Discussion
Immediate health concerns for the patient are often at the forefront of decision-making discussions prior
to amputation surgery, but long-term implications, specifically rehabilitation goals, need to be
incorporated into the discussion due to the impact amputation level and residual limb length can have on
these outcomes. Understanding the long-term implications of these decisions and working with the
rehabilitation team to establish a plan of care following amputation surgery can maximize the functional
outcomes for the patient upon discharge from care. This understanding and team decision making needs
to be initiated prior to the amputation surgery, when feasible, and should weigh factors surrounding the
decision to amputate as well as implications related to residual limb length and amputation level. Although
the body of evidence supporting this recommendation is limited, there are great benefits to the patient
and no known harms of this approach.
Long-term functional outcomes, including improved walking ability, favor more distal amputation levels.
Patients with limb loss levels distal to the ankle were more likely to be able to walk one kilometer within
one year of surgery compared to those with limb loss proximal to the ankle.[60] Similarly, patients with
more distal levels of limb loss (transmetatarsal and toe limb loss) demonstrated an increased ability to
complete ADLs relative to patients with more proximal amputation levels (transtibial or transfemoral limb
loss).[61,62] Increased mobility and decreased wheelchair use have also been demonstrated for those with
transtibial limb loss compared to transfemoral limb loss.[60] These factors can have a dramatic impact on
quality of life.[63] Improvements in quality of life and mobility were also noted for patients with knee
disarticulation as compared to transfemoral limb loss.[63] The potential advantages of more distal
amputation should be weighed against the possible increased risks of undergoing revision surgery.
Preservation of longer residual limb lengths helps to optimize a patient’s ability to ambulate. For patients
with transtibial limb loss, a longer residual limb has been noted to improve walking distance.[60] A similar
benefit was observed in patients with transfemoral limb loss who also demonstrated increased walking
speeds with greater residual limb lengths.[64] While considerations should be made to ensure available
clearance for desired componentry and the availability of adequate soft tissue for bone coverage and
closure, preserving maximum residual limb length will likely lead to improved rehabilitation outcomes for
most patients.
Including rehabilitation goals and outcomes in SDM may increase the time required to discuss implications
of the surgical decisions with the patient and rehabilitation team. This burden, however, is outweighed by

the long-term benefit of determining the most appropriate procedures that will maximize the well-being
and functional outcome of the patient. When setting goals and expectations, factors such as age, etiology
of amputation, comorbidities, and preoperative condition should be included, as they may influence the
level of achievable outcomes for the patient. More research is needed to determine the influence of these
factors, and other potential confounders, as well as provide more clarity between functional benefits for or
against joint disarticulations relative to a more proximal level of limb loss (e.g., ankle disarticulation versus
transtibial limb loss).
Recommendation
8. There is insufficient evidence to recommend one surgical amputation procedure over another.
(Not applicable | Reviewed, New-added)
Discussion
The end goal of any LLA surgical procedure is a well-healed and well-shaped residual limb that is free from
pain or other complications with excellent soft tissue characteristics. While the surgical procedure chosen
is most often related to the surgeon’s preference and experience, or determined after a conversation
between the surgeon and the patient, involving other members of the rehabilitation care team can better
align expected surgical outcomes with expected rehabilitation outcomes. If there is uncertainty of the
optimal length of the residual limb, pre-operative consultation with an experienced physiatrist or
prosthetist should be considered.
Of the various surgical procedures currently in use, only a few (e.g., Burgess versus Ertl, Gritti-Stokes
versus traditional transfemoral) have been directly compared in non-randomized observational studies.
[65-70] No one procedure has been shown to be clearly superior to another, or to lead to a clear
advantage in prosthesis use. Each procedure has its own advantages and disadvantages. More research is
needed in this area to further outline the strengths and weaknesses of the available procedures beyond
expert opinion.
Recommendation
9. We suggest the use of a rigid or semi-rigid dressing to promote healing and early prosthetic use as
soon as feasible post-amputation in transtibial amputation. Rigid post-operative dressings are
preferred in situations where limb protection is a priority.
Discussion
Residual limb management is an important determinant of successful recovery from amputation.[71]
Although the Work Group considered post-surgical dressing care an essential aspect of amputation care,
the evidence review did not identify any literature on post-surgical dressing options following transfemoral
amputation that met inclusion criteria.
Low quality evidence supports rigid removable (RRD) or semi-rigid (SRRD) dressings following transtibial
amputation to promote healing and early prosthetic use.[71,72] A fair quality SR and meta-analysis found
sufficient evidence to produce four empirical evidence statements.[72] Providers may consider these
statements in clinical decision making for postoperative care in transtibial amputation and as the basis for
future research on post-surgical care for transfemoral amputation:

1. In persons with acute transtibial amputation (TTA) from vascular disease, vacuum-formed
dressings are comparably effective at preparing the limb for prosthetic use and ambulation as
measured by the number of days from amputation to prosthetic fitting, wound healing rate, and
mobility compared with conventional Plaster of Paris dressings.
2. Following TTA, RRDs and SRRDs, with or without combined elastic compression, are more
effective at reducing acute post-amputation edema volume compared with conventional elastic
compression alone.
3. In persons with acute TTA, RRDs, compared with soft elastic dressings and bandaging, accelerate
residual limb healing time and reduce hospitalization time and are comparably effective at
reducing wound infection rate and time to prosthetic fitting.
4. In persons with acute TTA, articulated and non-articulated early walking aids are comparably
effective at improving 10 meter walking velocity and quality of life.
In addition, a 2003 review found that “The literature supports that rigid plaster cast dressings result in
significantly accelerated rehabilitation times and significantly less edema compared to soft gauze
dressings, and prefabricated pneumatic prostheses were found to have significantly fewer post-surgical
complications and required fewer higher-level revisions compared to soft gauze dressings.”[71] This
evidence was included in the 2007 LLA CPG.
Effective post-operative dressing management should maintain the integrity of the residual limb and
should:[71]
• Protect the residual limb
• Control and reduce edema
• Facilitate primary wound closure
• Maintain extension range of motion
• Facilitate advancement to prosthetic fitting
Rigid or semi-rigid protective devices that cross the knee joint can consistently accomplish the
aforementioned goals, when properly applied.[71] The decision making for the dressing begins pre-
operatively; however, the course of surgery intraoperatively may affect the final choice of dressings,
particularly if heavy contamination leads to the decision to perform an open amputation.
A 1971 study found that 6% of thigh-level rigid cast procedures required higher-level revisions, compared
with 22% of soft gauze dressings; however, due to small study sample sizes (n=182 total; n=45 soft
dressing, n=74 thigh-level rigid), there was insufficient statistical power to attain statistically significant
differences.[73] Therefore, the generalizability of the results is unclear. The age of the study also demands
that current research examine whether the findings could be replicated today.
Soft Dressings
A soft dressing is the least expensive and least time-consuming strategy, but may not be the optimal
strategy to maintain residual limb integrity. Soft dressings may result in complications, including high local

or proximal pressures that impair healing, a tendency to loosen and fall off, and an increased likelihood of
a knee flexion contracture.[71]
A very low quality RCT compared patient satisfaction between use of elastic bandage or custom-fit
compressive sock.[74] Either can reduce edema, although there was no statistically significant difference
between groups for patient satisfaction. Without a comparison to RRD or SRRD, this study serves to
highlight the variability in residual limb management and the lack of research on this subject, and raises
the question on how much of a role provider training impacts study outcomes.
Rigid or Semi-Rigid Dressings

No studies found any negative wound healing effects as a result of the application of rigid dressings. An SR
stated that following transtibial amputation, primarily in dysvascular patients, RRDs and SRRDs were found
to reduce acute post-amputation edema, healing time, hospitalization time, wound infection rate, and
time to prosthetic fitting compared with elastic (i.e., soft) dressings.[72]
Rigid or semi-rigid dressings include:

• Short removable rigid casts
• Thigh-level, non-removable rigid casts
• Thigh-level, non-removable rigid casts with removable immediate post-operative prosthesis
• Prefabricated pneumatic immediate post-operative prosthesis
Selection of soft, rigid, or semi-rigid dressings should consider trade-offs for individual patients (e.g.,
protection of the limb, risk of infection, need to inspect the incision site and skin, other factors).
Based on the low quality evidence for transtibial amputation, the lack of evidence for post-surgical care of
transfemoral amputation, and the difficulty with standardizing post-operative rigid dressings, this is a
priority area for future research, education, and clinical training.
Recommendation
10. We suggest performing cognitive screening prior to establishing rehabilitation goals, to assess the
patient’s ability and suitability for appropriate prosthetic technology.
Discussion
Performing cognitive screening prior to rehabilitation may assist in development of appropriate goals and
tailoring of the rehabilitation care plan. An SR reported that cognitive function has associations with
aspects of amputation rehabilitation and subsequent functioning.[75] Associations exist between
decreased cognitive function and failure of an individual with limb loss to be successfully fitted with a
prosthetic device. Poor cognitive function is also related to overall decreased prosthetic device use,
decreased mobility, loss of independence, and increased incidence of falls.[75] Additionally, cognitive
impairment is associated with a higher mortality rate and an undesirable variation in adherence to medical
regimens for individuals with LLA.[75]

The impaired cognitive domains of memory and executive function relate to the reduction of prosthetic
device use and decreased functional outcomes. Verbal fluency, a measure of executive function, has
been found to be predictive of prosthetic device use.[75] Cognitive status, particularly for individuals
without comorbidities, can be predictive of long-term mobility. Memory in the acute phase following
amputation is a predictor of long-term perceived health status and activity restriction. Visual memory is
a predictor of mobility and locomotion. Dementia prior to amputation is predictive of increased
mortality following amputation.[75]
This evidence supports assessing cognitive function, specifically memory and/or executive function, in
patients immediately after LLA.[75] While adequate cognitive assessment is time-consuming for the
clinician, valuable information can be gathered to help establish goals and determine prognosis. This
testing should always be coupled with continual reassessment of function and goals to assure the patient
will reach their full functional potential. Future research is needed to identify which specific cognitive tests
provide predictive value while being practical for clinical use with this patient population. Timing of the
screening should take into consideration potentially confounding comorbid conditions. Initial cognitive
screening by the rehabilitation team may indicate the need for referral to the appropriate specialist for
further cognitive testing. Continued reassessment may be indicated as appropriate.
Recommendation
11. We suggest that in the perioperative phase following amputation, patients receive physical
rehabilitation and appropriate durable medical equipment/assistive technology.
Discussion
Confidence in the quality of evidence is very low in support of patient participation in physical
rehabilitation following amputation to include the use of appropriate durable medical equipment (DME)
and assistive technology (AT); however, the benefits of implementing physical rehabilitation and the use of
DME and AT following amputation greatly outweigh the potential harms to the patient. Types of DME and
AT that are particularly relevant in the care of individuals with LLA include items such as wheelchairs,
walkers, canes, residual limb supports, bedside commode, and tub transfer bench. An SR found that
frequency of participation in occupational therapy sessions was significantly related to use of a prosthetic
device.[76] A second study demonstrated the importance of physical rehabilitation for improved
functional performance following LLA.[77] This study evaluated the efficacy of short intensive physical
therapy versus usual care (i.e., supervised walking). The study found that intensive physical rehabilitation
resulted in significant improvement in walking speed and weight tolerance on a prosthetic foot. While the
identified studies were graded as very low quality, they demonstrate the positive benefits and functional
outcomes for participation in physical rehabilitation following LLA, to include physical and occupational
therapy interventions.[76,77]
Research also supports the use of DME and AT in the perioperative phase following amputation. An SR
found that use of residual limb supports made wheelchairs more comfortable, helped protect the residual
limb, and increased overall acceptance of the amputation.[76] Included in the SR was an article in which
patients were educated in the use of residual limb supports for contracture prevention, edema control,
and protection of the residual limb.[78] This study described prescription of appropriate DME and AT

following amputation as being a key intervention for promoting functional independence and safety during
ADLs and mobility. The available evidence suggests the use of residual limb supports in the perioperative
phase of rehabilitation, but it is insufficient in providing recommendations for specific types of DME or AT.
The research currently available to support perioperative rehabilitation interventions following

amputation is limited. More research is needed to explore the pre-operative interventions and their effect
on functional outcomes following LLA.
Recommendation
12. We suggest, when applicable, treatment in an acute inpatient rehabilitation program over a skilled
nursing facility.
Discussion
A prospective cohort study of 297 patients supports that rehabilitation in an inpatient rehabilitation
facility (IRF) has distinct advantages compared to a skilled nursing facility (SNF).[79] This study found
that patients who received care in an IRF displayed improved quality of life, better ambulation and
confidence in gait, increased prosthetic device use, improved success with mobility overall, and fewer
complaints of pain with prosthetic device use compared to patients that received care in a SNF. These
findings are supported by other research that demonstrated improved 36-item Short-Form Health
Survey subscales for those in IRFs compared to those in SNFs.[80,81] Safety is often a concern with
these patients, however, current evidence does not support making a recommendation for an acute
inpatient rehabilitation setting rather than a SNF based upon safety alone.
Patients from the focus group acknowledged a preference for rehabilitation in a setting where treatment
was specialized to their needs. Resource use, feasibility, and subgroup considerations are also important
factors to consider when discussing rehabilitation settings with patients, as IRFs may not be easily
accessible to all patients.
When determining this to be a “Weak for” Recommendation, the Work Group had low confidence in the
quality of evidence. They also considered that benefits to the patients outweigh any potential harms.
Patients from the focus group acknowledged a preference for rehabilitation in a setting where treatment
was specialized to their needs. Resource use, feasibility, and subgroup considerations are also important
factors to consider when discussing rehabilitation settings with patients, as IRFs may not be easily
accessible to all patients.

Recommendation
13. We suggest the initiation of mobility training as soon as feasible post-amputation. In appropriate
patients, this may include ipsilateral side weight-bearing ambulation with a pylon to improve
physical function and gait parameters.
Discussion
While there is limited evidence to support out-of-bed activities and mobility training in the early post-
amputation period, these are generally well-accepted rehabilitation practices.[77,82] During the early
post-operative period, the clinician must consider several factors that may influence the timing, frequency,
and intensity of mobility training. These factors include overall medical stability, hemodynamic stability,
residual limb healing status, pain management, mental status, and fall risk. These variables and potential
risks need to be weighed against the benefits of early mobilization, which include improvements in
strength, cardiovascular fitness, bone health, and functional independence.
One consideration in the early mobilization after LLA is whether or not to utilize a weight-bearing
prosthetic device in the early post-amputation phase before the residual limb is healed. In addition to
the general benefits of early mobilization noted above, the potential advantages of using an early
weight-bearing prosthetic device include facilitating early mobilization, gait re-education, accelerated
stump healing, reduced complications, and facilitation of early definitive prosthetic fitting. The potential
disadvantages of this intervention include the risk of skin breakdown of the residual limb, increased
residual limb pain, and increased risk of falls. For some patients, there may be a psychological benefit
from early prosthetic device fitting.[83] When the decision is made to utilize an early weight-bearing
prosthetic device for a person with a transtibial level amputation, there are options for use of an
articulated prosthetic device that includes a thigh cuff and knee joints or a non-articulated device that
does not cross the knee. These devices can be initiated within the first week following amputation and
may include simple pylon and foot structures with adjustable sockets or sockets that include pneumatic
bladders for adjustability over time.[83]
While confidence in the quality of evidence examining the differences between articulated and non-
articulated early weight-bearing prosthetic devices is very low, the evidence supports improved outcomes
with the use of these systems.[83] In a controlled study, 29 subjects were randomized to receive either an
articulated or pneumatic, non-articulated early weight-bearing prosthetic device. Subjects were included in
the study if they were determined to tolerate an early walk aid and were expected to receive a functional
prosthetic device in the long term. Subjects were excluded if they were non-ambulatory prior to the
amputation surgery. The study noted improvements in both groups, but no statistically significant
differences between the groups with regard to long-term walking ability up to four years after surgery.
Limitations of this single study include a lack of outcome assessment blinding and an unclear
randomization process.[83]
Access to early weight-bearing prosthetic devices has expanded through the introduction of several
different prefabricated systems that are commercially available. Additional research is required to
further delineate the risks and benefits associated with this intervention as well as to further determine
the differences between articulated and non-articulated devices. Despite the need for additional

research, evidence suggests that mobility training should begin as soon as possible in the post-
amputation phase of rehabilitation.
Recommendation
14. We recommend instituting rehabilitation training interventions, using both open and closed chain
exercises and progressive resistance to improve gait, mobility, strength, cardiovascular fitness and
activities of daily living performance in order to maximize function.
(Strong for | Reviewed, New-replaced)
Discussion
One SR and two RCTs provide evidence in support of this recommendation. The SR evaluated the effect of
exercise programs on gait in patients with LLA, demonstrating that more intensive exercise-based
interventions (part-to-whole resisted gait training and functional gait training) improved self-selected
walking speed.[84] One RCT had mixed results examining the feasibility of a walking training program,
using an interactive gaming platform, in improving walking in older adults with LLA.[85] There were no
statistically significant differences for any result, although direction of effect favored active intervention
versus cognitive training as measured by the 2-minute walk test, a step activity monitor, and the walking
while talking test. One RCT examined the efficacy of proprioceptive neuromuscular facilitation techniques
compared to traditional prosthetic training in improving ambulatory function in patients with transtibial
amputation. The results favored intervention in regard to stride width and higher scores on the locomotor
capabilities index.[86] The intensity of the rehabilitation training intervention should be individualized in
order to maximize the benefit, as well as minimize potential complications that could occur when the
intensity level is inappropriate for the individual.
Despite the lack of strong evidence to support this recommendation, the potential harm from these
interventions is far less than the potential harm from immobility. There is some evidence, not included in
the evidence review, to support early mobilization in the intensive care unit and throughout the inpatient
stay.[87-92] Patient focus group feedback suggests that patients are shifting their expectations to demand
more robust rehabilitation following amputation with higher expectations for reintegration into the
community. A higher level of reintegration requires strength, endurance, and skill.
One of the main messages from the patient focus group was for rehabilitation providers to use real-world
training and outcome metrics tied to patients’ preinjury level of function and evolving personal goals.
Training models that mimic real-world situations in anticipation of community reintegration are already a
part of the rehabilitation process, although complex situations as noted by the patient focus group (e.g.,
walking through a crowded airport with luggage as others stop unexpectedly in the path, children running
across the individual’s path) may reflect a higher level of complexity than end points achieved in
rehabilitation settings. Of note, fluctuations in weight was a consensus area of concern among the focus
group participants as it directly impacts prosthetic device fit. Higher intensity exercise may play a lead role
in maintaining basal metabolic rate and baseline calorie burn, and thus may be a useful tool across
amputation-etiology patient populations.
Based on this patient input, functional ADLs should include transfers, practiced with and without a
prosthesis, including sit to stand, bed to chair, chair to toilet and tub, into and out of a vehicle, and on and
off the floor. Self-care training should include dressing, feeding, grooming, bathing, and toileting, with and

without a prosthesis. Rehabilitation providers should ensure that patients have the opportunity to discuss
all aspects of functional ADLs, including challenges with being intimate with a significant other. Consistent
with input from the patient focus group, adding more challenging real-world scenarios to the functional
ADL training is essential to patient confidence and reintegration to community living.
C. Pre-Prosthetic Phase
Recommendation
15. We suggest offering microprocessor knee units over non-microprocessor knee units for
ambulation to reduce risk of falls and maximize patient satisfaction. There is insufficient evidence
to recommend for or against any particular socket design, prosthetic foot categories, and
suspensions and interfaces.
(Weak for | Reviewed, New-added)
Discussion
According to two fair quality SRs, microprocessor knees may reduce risk of falls and maximize patient
satisfaction in limited and unlimited community ambulators.[93,94] Both reviews reported a decrease in
stumble and fall frequency with accommodation and use of a microprocessor knee system relative to a
non-microprocessor knee system.[93,94] The studies further support the prescription of microprocessor
knees over non-microprocessor knees to improve an individual’s ability to walk faster on level ground,
uneven surfaces, and downhill, thus providing the user with an improved sense of security and improved
overall satisfaction.[93,94] The Work Group considered that the benefits to the patients, particularly
decreasing risk of falling, far outweigh potential harms. The patient focus group participants also expressed
a desire to have access to prosthetic devices that fit well and maximize their safety and function, so patient
values and preferences were another important consideration when assessing the strength of the
recommendation.
Falling is a major issue in patients with transfemoral amputations. Increased number of falls, fear of falling,
as well as deterioration in balance, coordination, and endurance, resulting in activity avoidance, decreased
independence and mobility have all been reported in this population.[93] Therefore, the prescription of
microprocessor knees is supported for ambulatory individuals with complex medical conditions affecting
balance, as well as for the geriatric population. These populations benefit from microprocessor knees,
which have been demonstrated to decrease stumbles and prevent falls by an SR included in our evidence
review[93] and two SRs that were excluded because they were superseded by a more recent and
comprehensive SR.[95,96]
There is insufficient evidence to support using one type of microprocessor knee over another, but the
provider should consider the many characteristics of each type of knee when making a selection. Most
importantly, the potential impact on the patient’s functional level should be considered as there are a
variety of microprocessor knee options available. Some knees may be best suited for the limited
community ambulator[93] while others are more appropriate for the highly active patient.[72,97,98]
Another consideration when choosing the right microprocessor knee for an individual is the mechanism
of charging the knee; some have removable batteries, others have a port for a plug, while others have
inductive charging systems. Still another consideration would be the default mode of the device when
the power source is depleted. Some knees default to a locked knee while others default to free swing.

Finally, for the active user, additional options include activity modes and waterproof/water resistance
features, if appropriate. More research is needed to understand which patient subgroups benefit most
from access to microprocessor knee units.
There are inconclusive studies regarding differences in socket design, prosthetic foot categories, as well as
advantages and disadvantages of various types of suspensions and interfaces. Each component of a
prosthetic prescription should be carefully selected based on the capabilities and anticipated compliance
of the user as well as the integrity and shape of the residual limb. Patient desired outcomes, patient goals,
and the compatibility of the entire prosthetic system should also be a consideration when prescribing
prosthetic components.
D. Prosthetic Training Phase

Recommendation
16. We recommend the use of valid, reliable, and responsive functional outcome measures, including,
but not limited to, the Comprehensive High-level Activity Mobility Predictor, Amputee Mobility
Predictor, 10-meter walk test, and 6-minute walk test.
(Strong for | Reviewed, New-replaced)
Discussion
The use of outcome measures for periodic patient assessment at designated time points is an increasingly
important element of evidence-based practice.[99,100] Using validated objective outcome measures
throughout the rehabilitation process provides direct feedback to providers and patients regarding the
efficacy of therapeutic interventions and progress towards established functional goals. The use of
common data elements across healthcare institutions helps to standardize practice and improve the
overall quality of healthcare delivery.
When choosing from the numerous outcome measures available, it is important to first select a measure
that evaluates the construct of interest.[99,100] Other issues to consider include the administration
burden to patient and provider. Administration burden includes the time to administer, associated costs,
post-administration patient discomfort, and clinical logistics including the need for specialized equipment
in order to perform the measure. There are multiple other factors to consider in this selection process
including the level of measurement (e.g., nominal, ordinal, ratio), availability of reference or normative
values, and cutoff scores. However, while all of these are important to consider, among the most
important factors are whether or not the measure is valid, reliable, and responsive.
Outcome measures that are valid are identified as measuring the construct they are intended to measure.
Reliability is a psychometric property that indicates that the test will consistently provide the same
measure if no change has occurred. There are several forms of reliability that must be considered,
including test-retest, interrater and intrarater reliability, and internal consistency. Finally, it is imperative to
select measures that are sensitive or responsive to change. That is, the measure will reflect a clearly
different value when true patient change has occurred.
Outcome measures may be population specific [101,102] or they may have more general utility. The
Amputee Mobility Predictor (AMP) is a physical performance measure of functional mobility that takes

approximately 15 minutes to administer. It provides ordinal scale data and some studies, not included in
the evidence review, suggest that the AMP has validity, reliability, and responsiveness.[103,104]
Further, reference values are available so the rater may understand a patient’s score relative to others
of comparable etiology and functional level. A clinician, however, may require a more direct assessment
of walking ability and may have less than five minutes available to conduct an assessment. In this case,
some studies, not included in the evidence review, suggest that several outcome measures with validity,
reliability, and responsiveness may be more appropriate, including the 10-meter walk test, the 2- or 6-
minute walk test, or others.[103-107] The latter tests are not population specific and also have some
reference data available from patients with amputations as well as from other diagnostic groups.[103-
107] Refer to Table 3 for more information on physical performance measures with evidence of validity,
reliability, and/or responsiveness.
This recommendation was supported by moderate confidence in the quality of evidence and the
consideration that the benefits to patients of using valid, reliable, and responsive outcome measures
would outweigh any potential risks or harms. More research is needed to validate wheeled and other
mobility outcome measures.
Recommendation
17. We suggest the use of a combination of measures with acceptable psychometric properties to
assess functional outcomes.
Discussion
Because rehabilitative care requires assessment of multiple domains including walking ability, balance,
adjustment to prosthetic device use, quality of life, and others, it is suggested that multiple measures be
used to assess outcomes following LLA. Further, it has been established that patient preference is a key
component in fully assessing function in the patient with LLA.[72,98] In addition to selecting outcome
measures that are valid, reliable, and responsive, it is important to include comparably robust measures
from the patient’s perspective. Some examples are the Locomotor Capabilities Index [108] and the
Prosthesis Evaluation Questionnaire-Mobility Subscale,[109] both of which assess the patient’s
perception of his/her mobility capabilities. It may also be important to include an assessment of the
patient’s perceptions regarding his/her confidence with balance, in which case the Activities-specific
Balance Confidence Scale will be useful.[110] See Table 4 for a list of patient-reported outcome
measures which should be considered to complement the outcome measures of physical functional
performance in Table 3.
In addition to the measures in Table 3 and Table 4, it is worth noting that other domains may require
assessment. For example, it is often important to assess the location, severity, and type of pain (e.g., low
back, joint, phantom limb). Other phenomena that may require assessment include a specific recall of the
number of stumbles, semi-controlled falls, or uncontrolled falls, which may be included as part of a specific
instrument or can be asked separately.[95,97,98]
In summary, it is important to utilize measures that assess performance and outcomes in multiple
domains. Further, selected instruments should have strong psychometric properties including evidence of
validity, reliability, and responsiveness to change. Finally, multiple outcome measures may be necessary to

thoroughly assess the patient and track progress. However, multiple factors have to be considered when
choosing tests to assure minimal burden to the patient, the clinic and providers, and others.

Table 3. Measures of physical functional performance* [72,97,101-104,106,111-125]

Berg
Balance
TUG L-Test AMPnoPRO AMPPRO 4SST Test 10MWT 2MWT 6MWT HAI SAI CHAMP
Multi-
Walking
directional Walking
Functional Functional Functional Functional Walking Walking Walking ability ability on High level
Construct stepping & Balance ability on
mobility mobility mobility mobility ability ability & endurance hills & mobility
dynamic stairs
ramps
balance
Data Level Ratio Ratio Ordinal Ordinal Ratio Ordinal Ratio Ratio Ratio Ordinal Ordinal Ordinal
Admin.
≤5 min ≤5 min ≈15 min ≈15 min ≤5 min ≈15 min ≤5 min ≤5 min ≤10 min ≤5 min ≤5 min ≈15 min
Time
Evidence of
Yes Yes Yes Yes Yes No Yes Yes Yes Yes No Yes
Sensitivity?
Limb-trauma/
LLA: 33±15; salvage:
TTA: 30±13; TTA (K2, 361±29;
TFA: 42±17; LLA SACH foot): TTA (post-limb
LLA (K0/K1): (K0/K1): 51±8; TFA
Trauma: salvage): TFA Male
10±10; TFA (K3/K4): (K3/K4):
26±8; 25±7; TTA (K2, 391±57; (K3/K4): 11; Service
11-12±3; LLA: 11;
LLA LLA (K2): multi-axial TTA: 545±65; TTA (K2, Members
Normative/ PVD: 42±18; LLA (K2): dysvascular Limb IQR: 27; TTA (K2,
IQR: 9; 25±7; 35±7; foot): 55±3; salvage: SACH foot): with limb
Reference No WA: TTA (fallers): Mn: 53; TTA: 570±80; SACH foot):
Mn: 25; LLA (K3): TTA (K3/K4): 7; loss:
Data 26±6; LLA (K3): 33±10; 8.9; Md: 48; LLA (K0/K1): 11; Mn±SD:
Md: 23; 31±7; 41±4; 49±6 (39-56); TTA (K2,
Population WA: 43±18; dysvascular TTA: 9.6 Rng: 26- 50±30; TTA (K2,
Rng: 16-41 LLA (K4): LLA (varied multi-axial 22±8;
and Values WA <55 yo: LLA (K4): TTA (non- (sec) 141 LLA (K2): multi-axial
(sec) 39±3 level & foot): 7 Rng: 1-35
25±7 45±2 fallers): 18±8 (m) 190±111; foot): 12
(score out of etiology): (score out (score out
no WA ≥55 (score out (sec) LLA (K3): (score out of 40)
43) 51±5 (32-56) of 11);
yo: of 47) 299±102; of 13);
(score out of
40±17 56) LLA (K4):
(sec) 419±86
(m)
*All included outcomes have evidence of reliability and validity.
Abbreviations: 2MWT: 2-minute walk test; 4SST: four square step test; 6MWT: 6-minute walk test; 10MWT: 10-meter walk test; AMP: Amputee mobility predictor; CHAMP: Comprehensive High-level
Activity Mobility Predictor; HAI: Hill Assessment Index; IQR: interquartile range; K(0-4): Medicare functional levels; LLA: lower limb amputation; m: meter(s); Md: median; min: minutes; Mn: mean;
noPRO: without a prosthesis; PRO: with a prosthesis; PVD: peripheral vascular disease; Rng: range; SACH: Solid-ankle cushioned-heel; SAI: Stair assessment index; SD: standard deviation; sec: second(s);
TFA: transfemoral amputation; TTA: transtibial amputation; TUG: timed up and go; WA: walk aide; yo: years old

Table 4. Patient reported outcome measures* [97,104,108-110,115,117,126-128]

ABC PEQ-MS OPUS LCI-5 TAPES
ICF Domain Activities Activities Activities, Participation Activities Activities
Data Level Ordinal Ordinal Ordinal Ordinal Ordinal
Admin Time 5 min 5 min 6-30 min 10 min 5-10 min
Adjusting to amputation
Patient confidence in Perceived potential for Perceived function & Perceived potential for
Construct & demands of wearing a
balance mobility satisfaction with devices mobility
prosthesis
Items 16 12 87 or 88 14 34
Average all items Total score in each
Scoring Average all items (0-4) Sum of scores Not applicable
(0%-100%) section
Evidence of
Yes Not applicable Yes Yes Not applicable
Responsiveness
PVD LLA 54%; non-PVD
75%; w/mobility device TFA PVD 2.2 [97]; TTA
Quality of Life 40±10(0-
45%; no mobility device PVD 2.5; TFA Trauma TTA (K2, SACH foot)
Normative or Reference 62); Lower Limb
78%; total LLA 64%. TFA 2.8; TTA Trauma 3.1 45±18; TTA (K2, multi- Not applicable
Values Function 46±11(0-61);
PVD 2.0 [97]; TTA PVD 2.3; [115]: MFCL K2 1.4; K3 axial foot) 49±16
Satisfaction 46±11(0-63)
TFA Trauma 2.7; TTA 2.6; K4 3.2
Trauma 3.0
Elderly fall risk 67% [117];
Low Mobility <50%;
Cutoff Scores Moderate Mobility 50-80%; Not applicable Not applicable Not applicable Not applicable
Physically Active >80%
[128]
*All included outcomes have evidence of reliability and validity.
Abbreviations: ABC: Activities-Specific Balance Confidence Scale; ICF: International Classification of Functioning, Disability and Health; K(0-4): Medicare functional levels; LCI-5:
Locomotor Capabilities Index-5: LLA: lower limb amputation; MFCL: Medicare Functional Classification Level; min(s): minute(s); OPUS: Orthotic Prosthetic User Survey; PEQ-MS:
Prosthesis Evaluation Questionnaire-Mobility Subscale; PVD: peripheral vascular disease; SACH: solid-ankle cushioned-heel; TAPES: Trinity Amputation and Prosthesis Experience
Scales; TFA: transfemoral amputation; TTA: transtibial amputation

Recommendation
18. We recommend an assessment of factors that are associated with poorer outcomes following
acquired limb loss, such as smoking, comorbid injuries or illnesses, psychosocial functioning, and
pain.
(Strong for | Reviewed, Amended)
Discussion
Studies have shown that several patient-related factors, including comorbid trauma and/or illnesses, are
associated with poorer outcomes following an amputation.[129,130] When determining this to be a
“Strong for” recommendation, the Work Group had moderate confidence in the quality of evidence, and
several other key domains also supported this to be a “Strong for” recommendation. While many of these
comorbid conditions are common for individuals with acquired amputation, their potential impact on the
overall health and quality of life of the individual make them essential for assessment when designing
individualized rehabilitation plans. Thus, the benefits of addressing these factors greatly outweigh any
potential harm. Resource use and feasibility considerations also support a “Strong for” recommendation,
as the recommended assessments are feasible to perform in the clinical setting and do not require
significant resources.
Further evaluations and interventions that address a patient’s comorbidities improve the patient’s
overall health, and studies have shown that it also improves patient functional outcomes after an
amputation. A retrospective cohort study including 4,250 patients demonstrated that the premorbid
factors of chronic obstructive pulmonary disease (see the VA/DoD Chronic Obstructive Pulmonary
Disease CPG), 11 congestive heart failure, myocardial infarction within the previous six months, renal
disease on dialysis (see the VA/DoD Chronic Kidney Disease CPG), 12 a positive “do not resuscitate”
status, and a generally low premorbid functional status were all associated with an increased mortality
rate after amputation surgery.[129] A cross-sectional study of 368 patients also showed an association
between the presence of comorbidities and functional outcomes after amputation. This study used the
Trinity Amputation and Prosthetic Experience Scales (TAPES) to measure these outcomes. This includes
subscales for prosthetic satisfaction, psychosocial adjustment, and activity restriction.[130] Additionally,
the evidence showed an association between smoking and increased wound recurrence. In contrast,
another retrospective cohort study did not find an association between comorbidities and functional
outcome after amputation surgery; however, this study only included 256 patients.[131]
Vascular disease and smoking as well as overall health status can cause skin issues and impede post-
operative wound healing and also lead to recurrence of wounds following surgery (see the VA/DoD
Diabetes CPG). 13 This can delay the fitting of a prosthetic device and the ability of the person to function
11 See the VA/DoD Clinical Practice Guideline for the Management of Chronic Obstructive Pulmonary Disease. Available at:
https://www.healthquality.va.gov/guidelines/cd/copd/
12 See the VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease in Primary Care. Available at:
https://www.healthquality.va.gov/guidelines/CD/CKD/
13 See the VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus in Primary Care. Available at:
http://www.healthquality.va.gov/guidelines/CD/diabetes/

with that device. It can also affect the patient’s gait and pain levels. All of this leads to a decreased
functional status and decreased patient satisfaction.
Obesity is another problem that should be closely monitored as it significantly contributes to many of the
comorbid conditions already mentioned. Fluctuations in a patient’s weight can also affect the proper
fitting of the patient’s prosthetic socket and produce problems with the residual limb (see the VA/DoD
Management of Overweight and Obesity CPG). 14
Although the evidence review did not identify publications related to perioperative assessments, clinicians
should consider conducting a thorough medical assessment pre-operatively to evaluate the patient’s
physical condition, nutrition, infection risk, neuropsychiatric impairment (see the VA/DoD Major
Depressive Disorder CPG and the VA/DoD Posttraumatic Stress Disorder CPG),15,16 drug or alcohol use (see
the VA/DoD Substance Use Disorder CPG),17 and bowel and bladder function, as well as a review of
systems (cardiovascular, respiratory, endocrine, skin, neurological, and musculoskeletal). Chronic low back
pain is an issue that is often experienced after LLA, and should be monitored (see the VA/DoD Low Back
Pain CPG). 18 General supportive counseling (e.g., eliciting and validating the patient’s anxieties, fears, and
concerns) may also be helpful.
VIII. Knowledge Gaps and Recommended Research

There are a number of areas which require focused research, from stronger evidence to support current
recommendations to initial evidence to mature specificity of rehabilitation programs. In summary, the
Work Group recommends research on rehabilitation dosing and timing; association of rehabilitation
strategies with healthcare costs; and prescription parameters for technology, equipment, driver’s training,
home evaluation, home exercise program, and community integration by subgroups, including age,
etiology, gender, or other defining population characteristics.
A. Training programs
To further guide training programs for rehabilitation of LLA, well-designed, clinically relevant studies
examining balance interventions, outcomes, dosing, and treatment schedules are needed. More research
is also needed to understand the effect of high-intensity training programs on comorbidities such as low
back pain.
14 See the VA/DoD Clinical Practice Guideline for the Management of Obesity and Overweight. Available at:
https://www.healthquality.va.gov/guidelines/cd/obesity/
15 See the VA/DoD Clinical Practice Guideline for the Management of Major Depressive Disorder. Available at:
https://www.healthquality.va.gov/guidelines/MH/mdd/
16 See the VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Reaction.
Available at: https://www.healthquality.va.gov/guidelines/MH/ptsd/

17 See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorder. Available at:
http://www.healthquality.va.gov/guidelines/mh/sud/
18 See the VA/DoD Clinical Practice Guideline for the Diagnosis and Treatment of Low Back Pain. Available at:
http://www.healthquality.va.gov/guidelines/Pain/lbp/

B. Rehabilitation dosing
Further research is needed on high-dose versus low-dose rehabilitation, as well as dose timing. This should
also examine subgroup considerations (e.g., age, etiology, gender, other population characteristics).
C. Patient factors and considerations

When setting goals and expectations, considerations between differences in age, etiology, gender, and
comorbidities should be included, as they may influence the level of achievable outcomes for the patient.
More research is needed to determine the influence of these factors, and other potential confounders.
Clarity is needed between functional benefits for or against joint disarticulations relative to a more
proximal level of limb loss (e.g., ankle disarticulation versus transtibial limb loss). Evidence is needed to
better inform patients about amputation levels and the effect of level on key outcome variables. In
addition, many areas of clinical decision making use patient decision aids to enhance SDM, and
development of a tool for individuals with LLA may be useful.
D. Cognitive assessment
Continual reassessment of function and goals will reduce risk of setting a plan of care that will not allow
the patient to reach their full functional potential. Future research is needed to specifically identify which
cognitive tests provide predictive value while being practical for use in the clinic.
E. Perioperative LLA interventions

The research currently available to support perioperative rehabilitation interventions following
amputation is limited. More research is needed to explore the pre-operative interventions and their effect
on functional outcomes following LLA.
F. Prosthetic interventions
Access to early weight-bearing prostheses has expanded through the introduction of several different
prefabricated systems that are commercially available. More research is required to further delineate
the risks and benefits associated with this intervention as well as to further determine the differences
between articulated and non-articulated devices.
There are inconclusive studies regarding differences in socket design, prosthetic foot categories as well
as advantages and disadvantages of various types of suspensions and interfaces. A research goal should
be to optimize mobility and function through the most effective combination of wheeled and artificial
limb technologies.

Appendix A: Evidence Review Methodology

A. Developing the Scope and Key Questions
The CPG Champions, along with the Work Group, were tasked with identifying KQs to guide the evidence
review of the literature on LLA. These questions, which were developed in consultation with the Lewin
team, addressed clinical topics of the highest priority for the VA and DoD populations. The KQs follow the
population, intervention, comparison, outcome, timing and setting (PICOTS) framework for evidence
questions, as established by the Agency for Healthcare Research and Quality (AHRQ). Table A‐1 provides a
brief overview of the PICOTS typology.
Table A-1. PICOTS [132]

Patients, A description of the patients of interest. It includes the condition(s), populations or sub-
P Population, or populations, disease severity or stage, co-occurring conditions, and other patient
Problem characteristics or demographics.
Intervention or Refers to the specific treatments or approaches used with the patient or population. It
I Exposure includes doses, frequency, methods of administering treatments, etc.
Describes the interventions or care that is being compared with the intervention(s) of
C Comparison interest described above. It includes alternatives such as placebo, drugs, surgery, lifestyle
changes, standard of care, etc.
Describes the specific results of interest. Outcomes can include short, intermediate, and
O Outcome long-term outcomes, or specific results such as quality of life, complications, mortality,
morbidity, etc.
Timing, if Describes the duration of time that is of interest for the particular patient intervention and
(T) applicable outcome, benefit, or harm to occur (or not occur).
Setting, if Describes the setting or context of interest. Setting can be a location (such as primary,
(S) applicable specialty, or inpatient care).
The Champions, Work Group, and evidence review team carried out several iterations of this process, each
time narrowing the scope of the CPG and the literature review by prioritizing the topics of interest. Due to
resource constraints, all developed KQs were not able to be included in the systematic evidence review.
Thus, the Champions and Work Group determined which questions were of highest priority, and those
were included in the review. Table A-4 contains the final set of KQs used to guide the systematic evidence
review for this CPG.
a. Population(s)
Adults 18 years or older with lower extremity amputation treated in any VA/DoD clinical setting were
covered in this evidence review.
b. Interventions
Table A-2 below lists the interventions that were covered in this evidence review. The interventions are
listed according to the KQs they address.

Table A-2. Key Question Specific Interventions

Question Interventions
Prosthetic interventions
 Socket/interface (stump socket, below knee socket, above knee socket, through knee socket,
hydrostatic design [HSD socket], patella tendon bearing design, patella tendon bearing socket,
patellar tendon bearing [PTB] socket, total surface bearing [TSB] socket, ischial containment [IC]
socket, ischial ramus containment [IRC] socket, knee disarticulation socket, hip disarticulation
socket, vacuum-assisted socket system [VASS], total contact socket)
 Suspension system (elevated vacuum, vacuum assisted suspension, anatomic fit, osseointegration,
suspension sleeve, supracondylar, corset, pin suspension, locking mechanism, lanyard, thigh cuff,
belt)
1  Knee (microprocessor, non-microprocessor, hydromechanical, polycentric, single axis, Mauch SNS,
swing and stance, weight activated stance breaking, weight activated stance break (WASB), manual
locking knee, C-Leg, Power Knee, hydracadence, Rheo knee)
 Foot, ankle prosthetic components (energy storing and release [ES, ESR, ESAR], energy storing,
dynamic response, solid ankle cushioned heel [SACH], flexible keel, flex foot, PROPRIO foot, Biom
foot, single axis foot, multi-axial foot, running foot, cheetah)
 Socket/ interface (stump socket, below knee socket, above knee socket, through knee socket,
hydrostatic design, HSD socket, patella tendon bearing design, patella tendon bearing socket, PTB
socket, TSB socket, ischial containment socket, IC socket, IRC socket, knee disarticulation socket,
hip disarticulation socket, VASS, total contact socket)
Pre-operative rehabilitation interventions, including:
 patient education,
 core and hip strengthening,
 equipment ordering;
Interventions or combination of interventions in the immediate post-operative period, including:
 dressing (soft dressing, rigid dressing, rigid dressing with weight bearing, removable dressing),
 mental health screening/care,
 strengthening,
2  flexibility training,
 peer support,
 protection of contralateral limb,
 skin care,
 pain management,
 edema control,
 fall prevention,
 contracture prevention
Exposure
 demographic factors (such as age, sex, race, education, marital status, social support),
 comorbidities (such as diabetes, impaired cognition, posttraumatic stress disorder [PTSD],
3 neurological complications),
 characteristic of the amputation (such as traumatic vs. vascular, amputation level, local healing),
 pre-amputation functional status/mobility (K-level),
 pain level
Different approaches to gait and mobility training (treadmill, over ground, manual) including different
4
timing of intervention

Question Interventions
Tests being evaluated to predict outcomes
 6-minute walk test,
 step activity monitoring,
 amputee mobility predictor,
 cut points,
5
 timed up and go [TUG],
 threshold values,
 normative values,
 minimal change,
 psychometric
Exposure
 Age group,
 post-amputation period,
 gender,
 etiology,
6  pre-operative walking ability,
 employment status
 pre-operative morbidity,
 obesity,
 smoking history,
 exposure to peer visitation
Surgical interventions
 bone bridging,
7  targeted muscle reinnervation,
 myodesis,
 osseointegration
 any others
8 Different levels of amputation and different lengths within the level
9 One tapering strategy or schedule
10 Issues unique to female gender, populations with varying gender identification
c. Comparators
Table A-3 below lists the comparators of interest to this evidence review. The comparators are listed by
the KQ they address.

Table A-3. Key Question Specific Comparators

Question Comparators
1 Different types of prosthetic components compared to other types of components
2 Different rehabilitation interventions compared with each other, no pre-operative rehabilitation, no
rehabilitation
3 Patients lacking factors associated with better outcomes
4 Other approaches, different approaches compared to each other
5 Each test compared to another test
6 Subgroups with differences in exposures of interest (e.g., older versus younger patients, smokers
versus non-smokers, etc.)
7 Standard surgical intervention or different advanced surgical intervention
8 Comparisons between different levels, between lengths within a level
9 Other approaches to prevent amputation in the contralateral non-amputation limb
10 Male gender
d. Outcomes
For all KQs, the following outcomes were of interest in the evidence review:
• changes in functional status
• walking ability
• quality of life
• patient satisfaction
• strength
• pain
• morbidity
• safety (falls)
• complications
For KQ 9, the following outcomes were of interest in the evidence review:

• amputation
• gangrene
• ischemia
• infection of the contralateral limb
e. Timing
The timing considered in the evidence review was pre-operative or post-operative periods as specified
in each key question. There was no minimum follow-up.
f. Setting
Any setting was of interest in the evidence review.

B. Conducting the Systematic Review

Extensive literature searches identified 3,685 citations published from January 2007 through July 2016
potentially addressing the KQs of interest to this evidence review. Of those, 2,058 were excluded upon
title review for clearly not meeting inclusion criteria (e.g., not pertinent to the topic, not published in
English, published prior to study inclusion publication date, or not a full-length article). Overall, 1,627
abstracts were reviewed with 1,230 of those being excluded for the following reasons: not an SR or
clinical study, did not address a KQ of interest to this review, did not enroll a population of interest, or
published prior to January 2007. A total of 397 full-length articles were reviewed. Of those, 206 were
excluded at a first pass review for the following: not addressing a KQ of interest, not enrolling the
population of interest, not meeting inclusion criteria for clinical study or SR, not meeting inclusion
criteria for any KQ, or being a duplicate. A total of 191 full-length articles were thought to address one
or more KQs and were further reviewed. Of these, 114 were ultimately excluded. Reasons for their
exclusion are presented in Figure A-1 below.
Overall, 74 studies (in 77 publications) addressed one or more of the KQs and were considered as evidence
in this review. Table A-4 indicates the number of studies that addressed each of the KQs.

Figure A-1. Study Flow Diagram
2,058 Citations Excluded at the Title Level

3,685 Citations Identified by Searches Citations excluded at this level were off-topic, not
published in English, or published prior to
inclusion date
1,230 Citations Excluded at the Abstract Level

Citations excluded at this level were not SR or CS,
1,627 Abstracts
clearly did not address a KQ, did not report on an
Reviewed
outcome of interest, or were outside cutoff
publication dates
206 Citations Excluded at 1st Pass Full Article Level

Articles excluded at this level did not: address a key
question of interest, enroll the population of interest,
397 Full-length Articles Reviewed meet inclusion criteria for clinical study or systematic
review, meet inclusion criteria for any key question,
or were a duplicate.
114 Citations Excluded at 2nd Pass Full Article Level

30 Study did not meet minimum sample size
27 No multivariate analysis (KQ 3)
191 Articles 25 No outcome of interest or does not address a KQ
Reviewed 17 Did not meet study design criteria
15 Other
74 Included Studies (in 77 publications)
Abbreviations: CS: comparative study; KQ: key question; SR: systematic review

Table A-4. Evidence Base for Key Questions

Question Number of Studies
Number Question and Type of Studies
In patients with lower extremity amputations, which prosthetic (socket/ 5 SRs, 2 RCTs, and
interface, suspension system, knee, foot, ankle) optimizes patient function, 4 randomized
1 safety, and quality of life for the following? a. Hip disarticulation; b. Knee crossover trials
disarticulation; c. Ankle disarticulation; d. Transtibial amputation; e.
Transfemoral amputation; f. Partial foot amputation
In patients with scheduled or post lower limb amputation, what is the 2 SRs, 7 RCTs
2
effectiveness of rehabilitation interventions to improve outcomes?
For patients being considered for prosthesis, what factors (demographic, 4 SRs, 1 RCT, 7 cohort
3 clinical, biologic, environment, socioeconomic) are associated with better studies, 5 cross-
outcomes? sectional studies
In patients with lower limb amputation, what are the most effective gait 1 SR, 2 RCTs
4
training and mobility training interventions and timing?
What are the most sensitive, reliable and validated outcome measures when 1 randomized
assessing the outcomes of individuals with lower limb amputation? crossover study and 12
5
observational studies
(in 16 publications)
In patients with lower limb amputation, do the optimal approaches to No studies identified
rehabilitation differ by patient subgroup/risk category (e.g., different age
6 groups, gender, etiology, different post-amputation periods, premorbid
conditions and other risk factors such as obesity, smoking history, and
exposure to peer visitation)?
In patients with lower limb amputation, what are the benefits, risks, and 1 SR, 6 retrospective
7 outcomes associated with surgical interventions such as bone bridging, cohort studies
targeted muscle reinnervation, myodesis, or osseointegration?
In patients scheduled for lower limb amputation, what are the benefits, risks, 2 SRs, 10 cohort
and outcomes associated with the level of amputation and length within the studies, 1 cross-
8
level such as partial foot amputation compared to amputation at or below sectional study
knee level?
In patients with lower limb amputation, what is the comparative effectiveness 1 retrospective cohort
9 of various approaches to prevent amputation of the second limb or further study
amputation/progression of the first limb?
What are the unique issues that need to be addressed specifically for female, 2 cohort studies,
10 transgender, and other gender identification living with limb loss? What 1 cross-sectional
gender/sex health related issues influence the rehabilitation process? survey
74 studies
Total Evidence Base
(in 77 publications)
Abbreviations: RCT: randomized controlled trial; SR: systematic review
a. Criteria for Study Inclusion/Exclusion

i. General Criteria
• Clinical studies or SRs published on or after January 1, 2007 through July 31, 2016. If multiple
SRs addressed a key question, the most recent and/or comprehensive review was selected. SRs
were supplemented with clinical studies published subsequent to the SR.
• Studies must have been published in English.

• Publication must have been a full clinical study or SR; abstracts alone were not included.
Similarly, letters, editorials, and other publications that were not full-length clinical studies were
not accepted as evidence.
• Study must have enrolled at least 20 patients (10 per study group) unless otherwise noted (see
Key Question Specific Criteria below).
• Study must have reported on an outcome of interest.
• Study must have enrolled a patient population in which at least 80% of patients had lower limb
(rather than upper limb) amputation and were age 18 years or older. If the percentage was less
than 80%, then data must have been reported separately for this patient subgroup.
ii. Key Question Specific Criteria

• For KQs 1, 2, and 4, acceptable study designs included SRs and individual RCTs not evaluated in
SRs. If no relevant studies with these designs were found for a given KQ or sub-question,
prospective nonrandomized comparative studies were evaluated for inclusion.
• For KQ 3, acceptable study designs included SRs or RCTs that statistically compared outcomes
for patients with LLA and various risk factors to outcomes in patients without these risk factors.
Observational studies were acceptable if they performed multivariate statistical analyses of the
effect of co-occurring conditions on patient outcomes; the minimum patient enrollments were
100 for prospective studies and 200 for retrospective studies.
• For KQ 5, acceptable study designs included SRs, RCTs, or prospective cohort studies that
compare the accuracy of different measures of function levels and their ability to predict
prosthetic and rehabilitation outcomes
• For KQ 6, acceptable study designs included SRs, RCTs, or observational comparative studies
that compare different rehabilitation strategies and assessed differential treatment effects in
various subgroups of patients.
• For KQ 7, 8, and 9, acceptable study designs included SRs, RCTs, or any prospective or
retrospective comparative study that addressed the question.
• For KQ 10, any study that identified issues unique to females or individuals with varying gender
identification compared to males were included.
b. Literature Search Strategy

Information regarding the bibliographic databases, date limits, and platform/provider can be found in
Table A-5, below. Additional information on the search strategies, including topic-specific search terms
and search strategies can be found in Appendix F.

Table A-5. Bibliographic Database Information

Name Date Limits Platform/Provider
Bibliographic Databases
The Cochrane Database of Systematic Reviews (Cochrane Reviews) 2007 to June 13, 2016 Wiley
CINAHL 2007 to July 6, 2016 Wiley
EMBASE (Excerpta Medica) 2007 to July 6, 2016 Elsevier
Health Technology Assessment Database (HTA) 2007 to June 13, 2016 Wiley
MEDLINE/PreMEDLINE 2007 to July 6, 2016 Elsevier
PsycINFO 2007 to July 6, 2016 OVIDSP
PubMed (In-process and Publisher records) 2007 to July 6, 2016 NLM
Gray Literature Resources
AHRQ 2007 to July 7, 2016 AHRQ
C. Convening the Face-to-face Meeting

In consultation with the contracting officer’s representative, the Champions, and the Work Group, the
Lewin Team convened a three and a half day face-to-face meeting of the CPG Champions and Work Group
members on September 20-23, 2016. These experts were gathered to develop and draft the clinical
recommendations for an update to the 2007 LLA CPG. Lewin presented findings from the evidence review
of KQs 1-10 in order to facilitate and inform the process.
Under the direction of the Champions, the Work Group members were charged with interpreting the
results of the evidence review, and asked to categorize and carry forward recommendations from the
2007 LLA CPG, modifying the recommendations as necessary. The members also developed new clinical
practice recommendations not presented in the 2007 LLA CPG, based on the 2016 evidence review. The
subject matter experts were divided into two smaller subgroups at this meeting.
As the Work Group members drafted clinical practice recommendations, they also assigned a grade for
each recommendation based on a modified GRADE and USPSTF methodology. Each recommendation was
graded by assessing the quality of the overall evidence base, the associated benefits and harms, the
variation in values and preferences, and other implications of the recommendation.
In addition to developing recommendations during the face-to-face meeting, the Work Group members
also revised the 2007 LLA CPG algorithms to reflect the new and amended recommendations. They
discussed the available evidence as well as changes in clinical practice since 2007, as necessary, to update
the algorithms.

D. Grading Recommendations
This CPG uses the GRADE methodology to assess the quality of the evidence base and assign a grade for
the strength for each recommendation. The GRADE system uses the following four domains to assess the
strength of each recommendation:[23]
• Balance of desirable and undesirable outcomes
• Confidence in the quality of the evidence
• Values and preferences
• Other implications, as appropriate, e.g.,:
 Resource use
 Equity
 Acceptability
 Feasibility
 Subgroup considerations
The following sections further describe each domain.
Balance of desirable and undesirable outcomes refers to the size of anticipated benefits (e.g., increased
longevity, reduction in morbid event, resolution of symptoms, improved quality of life, decreased
resource use) and harms (e.g., decreased longevity, immediate serious complications, adverse event,
impaired quality of life, increased resource use, inconvenience/hassle) relative to each other. This
domain is based on the understanding that the majority of clinicians will offer patients therapeutic or
preventive measures as long as the advantages of the intervention exceed the risks and adverse effects.
The certainty or uncertainty of the clinician about the risk-benefit balance will greatly influence the
strength of the recommendation.
Some of the discussion questions that fall under this domain include:
• Given the best estimate of typical values and preferences, are you confident that the benefits
outweigh the harms and burden or vice versa?
• Are the desirable anticipated effects large?
• Are the undesirable anticipated effects small?
• Are the desirable effects large relative to undesirable effects?
Confidence in the quality of the evidence reflects the quality of the evidence base and the certainty in
that evidence. This second domain reflects the methodological quality of the studies for each outcome
variable. In general, the strength of recommendation follows the level of evidence, but not always, as
other domains may increase or decrease the strength. The evidence review used for the development of
recommendations for LLA, conducted by ECRI, assessed the confidence in the quality of the evidence base
and assigned a rate of “High,” “Moderate,” “Low,” or “Very Low.”

The elements that go into the confidence in the quality of the evidence include:
• Is there high or moderate quality evidence that answers this question?
• What is the overall certainty of this evidence?
Values and preferences is an overarching term that includes patients’ perspectives, beliefs, expectations,
and goals for health and life. More precisely, it refers to the processes that individuals use in considering
the potential benefits, harms, costs, limitations, and inconvenience of the therapeutic or preventive
measures in relation to one another. For some, the term “values” has the closest connotation to these
processes. For others, the connotation of “preferences” best captures the notion of choice. In general,
values and preferences increase the strength of the recommendation when there is high concordance and
decrease it when there is great variability. In a situation in which the balance of benefits and risks are
uncertain, eliciting the values and preferences of patients and empowering them and their surrogates to
make decisions consistent with their goals of care becomes even more important. A recommendation can
be described as having “similar values,” “some variation,” or “large variation” in typical values and
preferences between patients and the larger populations of interest.
Some of the discussion questions that fall under the purview of values and preferences include:
• Are you confident about the typical values and preferences and are they similar across the
target population?
• What are the patient’s values and preferences?
• Are the assumed or identified relative values similar across the target population?
Other implications consider the practicality of the recommendation, including resources use, equity,
acceptability, feasibility and subgroup considerations. Resource use is related to the uncertainty around
the cost-effectiveness of a therapeutic or preventive measure. For example statin use in the frail elderly
and others with multiple co-occurring conditions may not be effective and depending on the societal
benchmark for willingness to pay, may not be a good use of resources. Equity, acceptability, feasibility, and
subgroup considerations require similar judgments around the practically of the recommendation.
The framework below (Table A-6) was used by the Work Group to guide discussions on each domain.

Table A-6. Evidence to Recommendation Framework

Decision Domain Judgment
Balance of desirable and undesirable outcomes
 Given the best estimate of typical values and preferences, are you Benefits outweigh harms/burden
confident that the benefits outweigh the harms and burden or vice
versa? Benefits slightly outweigh harms/burden
 Are the desirable anticipated effects large? Benefits and harms/burden are balanced
 Are the undesirable anticipated effects small? Harms/burden slightly outweigh benefits
 Are the desirable effects large relative to undesirable effects? Harms/burden outweigh benefits
Confidence in the quality of the evidence

High
 Is there high or moderate quality evidence that answers this
Moderate
question?
Low
 What is the overall certainty of this evidence?
Very low
Values and preferences
 Are you confident about the typical values and preferences and are
they similar across the target population? Similar values
 What are the patient’s values and preferences? Some variation
 Are the assumed or identified relative values similar across the target Large variation
population?
Other implications (e.g., resource use, equity, acceptability, feasibility, subgroup considerations)
 Are the resources worth the expected net benefit from the
recommendation?
 What are the costs per resource unit?
 Is this intervention generally available? Various considerations
 Is this intervention and its effects worth withdrawing or not allocating
resources from other interventions?
 Is there lots of variability in resource requirements across settings?
The strength of a recommendation is defined as the extent to which one can be confident that the
desirable effects of an intervention outweigh its undesirable effects and is based on the framework above,
which combines the four domains.[23] GRADE methodology does not allow for recommendations to be
made based on expert opinion alone. While strong recommendations are usually based on high or
moderate confidence in the estimates of effect (quality of the evidence) there may be instances where
strong recommendations are warranted even when the quality of evidence is low.[133] In these types of
instances where the balance of desirable and undesirable outcomes and values and preferences played
large roles in determining the strength of a recommendation, this is explained in the discussion section for
the recommendation.
The GRADE of a recommendation is based on the following elements:

• Four decision domains used to determine the strength and direction (described above)
• Relative strength (Strong or Weak)
• Direction (For or Against)

The relative strength of the recommendation is based on a binary scale, “Strong” or “Weak.” A strong
recommendation indicates that the Work Group is highly confident that desirable outcomes outweigh
undesirable outcomes. If the Work Group is less confident of the balance between desirable and
undesirable outcomes, they present a weak recommendation.
Similarly, a recommendation for a therapy or preventive measure indicates that the desirable
consequences outweigh the undesirable consequences. A recommendation against a therapy or
preventive measure indicates that the undesirable consequences outweigh the desirable consequences.
Using these elements, the grade of each recommendation is presented as part of a continuum:
• Strong For (or “We recommend offering this option …”)
• Weak For (or “We suggest offering this option …”)
• Weak Against (or “We suggest not offering this option …”)
• Strong Against (or “We recommend against offering this option …”)
Note that weak (For or Against) recommendations may also be termed “Conditional,” “Discretionary,” or
“Qualified.” Recommendations may be conditional based upon patient values and preferences, the
resources available, or the setting in which the intervention will be implemented. Recommendations may
be at the discretion of the patient and clinician or they may be qualified with an explanation about the
issues that would lead decisions to vary.
E. Recommendation Categorization
a. Recommendation Categories and Definitions
For use in the 2017 LLA CPG, a set of recommendation categories was adapted from those used by the
United Kingdom National Institute for Health and Clinical Excellence.[26,27] These categories, along with
their corresponding definitions, were used to account for the various ways in which recommendations
could have been updated from the 2007 LLA CPG. The categories and definitions can be found in Table A-
7.

Table A-7. Recommendation Categories and Definitions

Evidence Recommendation
Reviewed* Category* Definition*
New-added New recommendation following review of the evidence
Recommendation from previous CPG that has been carried over to the
New-replaced
updated CPG that has been changed following review of the evidence
Recommendation from previous CPG that has been carried forward to the
Not changed updated CPG where the evidence has been reviewed but the recommendation
Reviewed is not changed
Recommendation from the previous CPG that has been carried forward to the
Amended updated CPG where the evidence has been reviewed and a minor amendment
has been made
Recommendation from the previous CPG that has been removed based on
Deleted
review of the evidence
Recommendation from previous CPG that has been carried forward to the
Not changed
updated CPG, but for which the evidence has not been reviewed
Recommendation from the previous CPG that has been carried forward to the
Not reviewed Amended updated CPG where the evidence has not been reviewed and a minor
amendment has been made
Recommendation from the previous CPG that has been removed because it
Deleted
was deemed out of scope for the updated CPG
*Adapted from the NICE guideline manual (2012) [26] and Garcia, et al. (2014) [27]
Abbreviation: CPG: clinical practice guideline
b. Categorizing Recommendations with an Updated Review of the Evidence

Recommendations were first categorized by whether or not they were based on an updated review of the
evidence. If evidence had been reviewed, recommendations were categorized as “New-added,” “New-
replaced,” “Not changed,” “Amended,” or “Deleted.”
“Reviewed, New-added” recommendations were original, new recommendations that were not in the
2007 LLA CPG. “Reviewed, New-replaced” recommendations were in the previous version of the guideline,
but were modified to align with the updated review of the evidence. These recommendations could have
also included clinically significant changes to the previous version. Recommendations categorized as
“Reviewed, Not changed” were carried forward from the previous version of the CPG unchanged.
To maintain consistency between 2007 recommendations, which were developed using the USPSTF
methodology, and 2017 recommendations, which were developed using the GRADE methodology, it was
necessary to modify the 2007 recommendations to include verbiage to signify the strength of the
recommendation (e.g., “We recommend,” “We suggest”). Because the 2007 recommendations inherently
needed to be modified at least slightly to include this language, the “Not changed” category was not used.
For recommendations carried forward to the updated CPG with review of the evidence and slightly
modified wording, the “Reviewed, Amended” recommendation category was used. This allowed for the
wording of the recommendation to reflect GRADE methodology as well as for any other non-substantive
(i.e., not clinically meaningful) language changes deemed necessary. The evidence used to support these
recommendations was carried forward from the previous version of the CPG and/or was identified in the
evidence review for the update.

Recommendations could have also been designated “Reviewed, Deleted.” These were recommendations
from the previous version of the CPG that were not brought forward to the updated guideline after review
of the evidence. This occurred if the evidence supporting the recommendations was out of date, to the
extent that there was no longer any basis to recommend a particular course of care and/or new evidence
suggests a shift in care, rendering recommendations in the previous version of the guideline obsolete.
c. Categorizing Recommendations without an Updated Review of the Evidence

There were also cases in which it was necessary to carry forward recommendations from the previous
version of the CPG without an SR of the evidence. Due to time and budget constraints, the update of the
LLA CPG could not review all available evidence on rehabilitation of LLA, but instead focused its KQs on
areas of new or updated scientific research or areas that were not previously covered in the CPG.
For areas of research that have not changed, and for which recommendations made in the previous
version of the guideline were still relevant, recommendations could have been carried forward to the
updated guideline without an updated SR of the evidence. The support for these recommendations in the
updated CPG was thus also carried forward from the previous version of the CPG. These recommendations
were categorized as “Not reviewed.” If evidence had not been reviewed, recommendations could have
been categorized as “Not changed,” Amended,” or “Deleted.”
“Not reviewed, Not changed” recommendations refer to recommendations from the previous version of
the LLA CPG that were carried forward unchanged to the updated version. The category of “Not reviewed,
Amended” was used to designate recommendations which were modified from the 2007 CPG with the
updated GRADE language, as explained above.
Recommendations could also have been categorized as “Not reviewed, Deleted” if they were determined
to be out of scope. A recommendation was out of scope if it pertained to a topic (e.g., population, care
setting, treatment, condition) outside of the scope for the updated CPG as defined by the Work Group.
The categories for the recommendations included in the 2017 version of the guideline are noted in the
Recommendations. Recommendations 1, 2, 3, 6, 7, 8, 10, and 19 were carried forward from the 2007 LLA
CPG using this method. The categories for the recommendations from the 2007 LLA CPG are noted in
Appendix C.
F. Drafting and Submitting the Final Clinical Practice Guideline

Following the face-to-face meeting, the Champions and Work Group members were given writing
assignments to craft discussion sections to support each of the new recommendations and/or to update
discussion sections from the 2007 LLA CPG to support the amended “carried forward” recommendations.
The Work Group also considered tables, appendices, and other sections from the 2007 LLA CPG for
inclusion in the update. During this time, the Champions and Work Group also made additional revisions to
the algorithms, as necessary.
After developing the initial draft of the updated CPG, an iterative review process was used to solicit
feedback on and make revisions to the CPG. Once they were developed, the first two drafts of the CPG
were posted on a wiki website for a period of 14-20 business days for internal review and comment by the

Work Group. All feedback submitted during each review period was reviewed and discussed by the Work
Group and appropriate revisions were made to the CPG.
Draft 3 of the CPG was made available for peer review and comment. This process is described in Peer
Review Process. After revisions were made based on the feedback received during the peer review and
comment period, the Champions presented the CPG to the EBPWG for their approval. Changes were made
based on feedback from the EBPWG and the guideline was finalized.
The Work Group also produced a set of guideline toolkit materials which included a provider summary,
pocket card, and a patient summary. The final 2017 LLA CPG was submitted to the EBPWG in September,
2017.

Appendix B: Evidence Table

Strength of Recommendation
Recommendation 2007 Grade1 Evidence2 Recommendation 3 Category 4
1. We suggest that patient education be provided by the B [21,22,35,36] Weak for Reviewed, Amended
rehabilitation care team throughout all phases of C Additional References:
amputation rehabilitation. None [37-39]
2. We suggest an assessment of behavioral health and B [40-45] Weak for Reviewed, Amended
psychosocial functioning at every phase of amputation None
management and rehabilitation. None
None
None
3. When assessing pain, we suggest that measurement of Expert opinion [46] Weak for Reviewed, Amended
the intensity of pain and interference with function B Additional References:
should be separately assessed for each pain type and None [47-49]
location using standardized tools. None
1 The 2007 VA/DoD LLA CPG used the USPSTF evidence grading system (http://www.uspreventiveservicestaskforce.org). Inclusion of more than one 2007 Grade indicates that more
than one 2007 CPG recommendation is covered under the 2016 recommendation. The strength of recommendations were rated as follows: A- a strong recommendation that the
clinicians provide the intervention to eligible patients; B- a recommendation that clinicians provide (the service) to eligible patients; C- no recommendation for or against the
routine provision of the intervention is made; D- recommendation is made against routinely providing the intervention; I- the conclusion is that the evidence is insufficient to
recommend for or against routinely providing the intervention; Expert Opinion- the recommendation was developed using expert consensus regarding clinical standard of care,
but was not based on a review of the available evidence. None- indicates that the 2017 LLA CPG recommendation replaced or amended a 2007 LLA CPG recommendation for
which there was no grade. Not applicable- indicates that the 2017 LLA CPG recommendation was a new recommendation, and therefore does not have an associated 2007 grade.
2 The evidence column indicates studies that support each recommendation. For new recommendations, developed by the 2016 guideline Work Group, the literature cited
corresponds directly to the 2016 evidence review. For recommendations that have been carried over from the 2007 VA/DoD LLA CPG, slight modifications were made to the
language in order to better reflect the current evidence and/or the change in grading system used for assigning the strength of each recommendation (USPSTF to GRADE). For
these “modified” recommendations, the evidence column indicates “additional evidence,” which can refer to either 1) studies that support the recommendation and which were
identified through the 2016 evidence review, or 2) relevant studies that support the recommendation, but which were not systematically identified through a literature review.
3 Refer to the Grading Recommendations section for more information on how the strength of the recommendation was determined using GRADE methodology.
4 Refer to the Recommendation Categorization section for more information on the description of the categorization process and the definition of each category.

4. We suggest offering a multi-modal, transdisciplinary I [50,52,53] Weak for Reviewed, New-
individualized approach to pain management including B Additional Reference: replaced
transition to a non-narcotic pharmacological regimen I [51]
combined with physical, psychological, and mechanical Expert Opinion
modalities throughout the rehabilitation process (For C
the treatment of chronic pain, the 2017 VA/DoD CPG
I
for the Management of Opioid Therapy for Chronic Pain
recommends alternatives to opioid therapy such as
self-management strategies, other non-
pharmacological treatments, and non-opioids over
opioids [see the 2017 VA/DoD OT CPG 1]).
5. We recommend providers consider the patient’s birth Not applicable [54-57] Strong for Reviewed, New-added
sex and self-identified gender identity in developing Additional Reference:
individualized treatment plans. [11]
6. We suggest offering peer support interventions, C [58] Weak for Reviewed, Amended
including visitation by a certified peer visitor, as early as I Additional References:
feasible and throughout the rehabilitation process. [38,59]
7. Prior to surgery, we suggest that rehabilitation goals, None [60-64] Weak for Reviewed, Amended
outcomes, and other implications be included in shared None
decision making about residual limb length and
amputation level.
8. There is insufficient evidence to recommend one Not applicable [65-70] Not applicable Reviewed, New-added
surgical amputation procedure over another.
9. We suggest the use of a rigid or semi-rigid dressing to None [71-74] Weak for Reviewed, Amended
promote healing and early prosthetic use as soon as B
feasible post-amputation in transtibial amputation. B
Rigid post-operative dressings are preferred in None
situations where limb protection is a priority. None
None
1 See the VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. Available at: http://www.healthquality.va.gov/guidelines/Pain/cot/

10. We suggest performing cognitive screening prior to None [75] Weak for Reviewed, New-
establishing rehabilitation goals, to assess the patient’s None replaced
ability and suitability for appropriate prosthetic None
technology. None
11. We suggest that in the perioperative phase following None [76-78] Weak for Reviewed, New-
amputation, patients receive physical rehabilitation and None replaced
appropriate durable medical equipment/assistive None
technology. None
None
None
12. We suggest, when applicable, treatment in an acute None [79-81] Weak for Reviewed, New-
inpatient rehabilitation program over a skilled nursing None replaced
facility. None
13. We suggest the initiation of mobility training as soon as None [77,82,83] Weak for Reviewed, New-
feasible post-amputation. In appropriate patients, this replaced
may include ipsilateral side weight-bearing ambulation
with a pylon to improve physical function and gait
parameters.
14. We recommend instituting rehabilitation training None [84-86] Strong for Reviewed, New-
interventions, using both open and closed chain None Additional References: replaced
exercises and progressive resistance to improve gait, None [87-92]
mobility, strength, cardiovascular fitness and activities None
of daily living performance in order to maximize None
function.
None
None
None
15. We suggest offering microprocessor knee units over Not applicable [72,93-96] Weak for Reviewed, New-added
non-microprocessor knee units for ambulation to Additional References:
reduce risk of falls and maximize patient satisfaction. [97,98]
There is insufficient evidence to recommend for or
against any particular socket design, prosthetic foot
categories, and suspensions and interfaces.

16. We recommend the use of valid, reliable, and None [101,102] Strong for Reviewed, New-
responsive functional outcome measures, including, None Additional References: replaced
but not limited to, the Comprehensive High-level [99,100,103-107]
Activity Mobility Predictor, Amputee Mobility Predictor,
10-meter walk test, and 6-minute walk test.
17. We suggest the use of a combination of measures with None [72,115] Weak for Reviewed, New-
acceptable psychometric properties to assess None Additional References: replaced
functional outcomes. [95,97,98,108-110]
18. We recommend an assessment of factors that are None [129-131] Strong for Reviewed, Amended
associated with poorer outcomes following acquired None
limb loss, such as smoking, comorbid injuries or None
illnesses, psychosocial functioning, and pain. B
B
B
B
B
B
B
None
None
None
None
None
None

Appendix C: 2007 Recommendation Categorization Table

2007 Module 1
2007 Number
2007 Section
2007 Recommendation 2016

2007 Recommendation Text 2 Grade 3 Category 4 Recommendation 5
CORE 1 1 Key disciplines to be consulted during the preoperative (when possible) and postoperative None Not Reviewed,
phases of rehabilitation care include: physiatry, surgery, physical therapy, occupational Deleted
therapy, prosthetics, social work services, case management, mental health, nursing,
nutrition, and recreation therapy. In addition, the following specialties should be available
on a case-by-case basis: vascular surgery, plastic surgery, internal medicine, pain
management, vocational therapy, and spiritual advisors.
CORE 1 2 The patient and family members (or other caregivers) should be an integral part of the None Not Reviewed,
interdisciplinary rehabilitation team. Deleted
CORE 1 3 Interdisciplinary rehabilitation team meetings should be conducted on a regular basis within None Not Reviewed,
the institution to facilitate communication and integration of a comprehensive treatment Deleted
plan.
CORE 1 4 Outpatient amputation clinics should have interdisciplinary team participation for the None Not Reviewed,
periodic assessment of patients to ensure appropriate life-long care in order to preserve the Deleted
quality of life, achievement of maximum function, and reduction of secondary
complications.
CORE 2 1 Evaluations from all key team members should be included in the development of the None Not Reviewed,
treatment plan. Deleted
CORE 2 2 The treatment plan must address identified rehabilitation, medical, mental health, and None Not Reviewed,
surgical problems. Deleted
1 The first three columns indicate the location of each recommendation within the 2007 LLA CPG.
2 The 2007 Recommendation Text column contains the wording of each recommendation from the 2007 LLA CPG.
3 The 2007 VA/DoD LLA CPG used the U.S. Preventive Services Task Force (USPSTF) evidence grading system (http://www.uspreventiveservicestaskforce.org). The strength of
recommendations were rated as follows: A- a strong recommendation that the clinicians provide the intervention to eligible patients; B- a recommendation that clinicians provide
(the service) to eligible patients; C- no recommendation for or against the routine provision of the intervention is made; D- recommendation is made against routinely providing
the intervention; I- the conclusion is that the evidence is insufficient to recommend for or against routinely providing the intervention; Expert Opinion- the recommendation was
developed using expert consensus regarding clinical standard of care, but was not based on a review of the available evidence. None- indicates there was no grade assigned to
the recommendation in the 2007 LLA CPG.
4 The Recommendation Category column indicates the way in which each 2007 LLA CPG recommendation was updated.
5 For recommendations that were carried forward to the 2007 LLA CPG, this column indicates the new recommendation(s) to which they correspond.

2007 Module 1
2007 Number
2007 Section 2007 Recommendation 2016
CORE 2 3 The treatment plan should identify realistic treatment goals. None Not Reviewed,
Deleted
CORE 2 4 The treatment plan should identify and address plans for discharge at the initiation of the None Not Reviewed,
rehabilitation process. The discharge treatment plan should include needs for specialized Deleted
equipment, evaluation of and required modifications of the discharge environment, needs
for home assistance, and an evaluation of the patient’s ability to drive (see CORE-9: Social
Environment).
CORE 2 5 The initial treatment plan should be established early in the rehabilitation process and None Not Reviewed,
updated frequently based on patient progress, emerging needs, or problems. Deleted
CORE 2 6 The treatment plan should indicate the anticipated next phase of rehabilitation care. None Not Reviewed,
Deleted
CORE 3 1 Pain should be assessed at all phases of rehabilitation, preferably with a tool specific to pain Expert Reviewed, New- Recommendation 3
assessment in patients with lower limb amputations. [Expert Opinion] Opinion replaced
CORE 3 2 When assessing pain, standardized tools should be used. Examples include; Visual Analogue B Reviewed, Recommendation 3
Scale (VAS), Short Form McGill Pain Questionnaire (SF-MPQ), and Pain Interference Scale Amended
(PIS). [B]
CORE 3 3 When possible, a postoperative treatment plan for pain control should be developed before I Reviewed, New- Recommendation 4
surgery and be based on the preoperative pain assessment and treatment initiated. [I] replaced
CORE 3 4 Measurement of the intensity of pain should be separately assessed at each site (i.e., B Reviewed, Recommendation 4
phantom limb pain [PLP], residual limb pain [RLP], low back pain [LBP]) to achieve a Amended
thorough assessment of pain-related impairment. [B]
CORE 3 5 Prophylactic pain management should be considered prior to initiation of physical I Reviewed, New- Recommendation 4
rehabilitation intervention. [I] replaced
CORE 3 6 Narcotic analgesics should be considered in the immediate postoperative phase. [Expert Expert Reviewed, New- Recommendation 4
Opinion] Opinion replaced
CORE 3 7 Transition to a non-narcotic pharmacological regimen combined with physical, C Reviewed, New- Recommendation 4
psychological, and mechanical modalities should be considered throughout the replaced
rehabilitation process. Treatment should target pain related to the residual/phantom limb
and address pain in other body parts from a primary care approach. [C]

2007 Module 1
2007 Number
CORE 3 8 There is no consistent evidence to support or refute one specific type of pain control. I Reviewed, New- Recommendation 4
Available modalities include: [I] replaced
a. Pharmacological: anti-seizure medications (e.g., gabapentin), tricyclic antidepressants
(TCA), selective serotonin re-uptake inhibitors (SSRI), non-steroidal anti-inflammatory
drugs (NSAID), dextromethorathane, and long-acting narcotics
b. Epidural analgesia, use of patient controlled analgesia (PCA), or regional analgesia may
be considered, although the benefit is unproven
c. Non-pharmacological: transcutaneous electrical nerve stimulation (TENS),
desensitization, scar mobilization, relaxation, and biofeedback.
(See the VA/DoD Clinical Practice Guideline for the Management of Acute Postoperative
Pain.)
CORE 4 1 Medical status including laboratory studies should be assessed and monitored as indicated None Not reviewed,
to screen for infection, anemia, electrolyte imbalances, nutrition, and liver and kidney Deleted
diseases.
CORE 4 2 The comprehensive medical care throughout the phases of rehabilitation of patient with None Reviewed, New- Recommendation
amputation should address: replaced 18
a. Cardiac and pulmonary function
b. Assessment and monitoring for infection using laboratory and radiographic studies
c. Assessment and management of diabetes and its complications to improve outcome and
reduce the risk for complication and further amputation
d. Assessment and management of peripheral vascular diseases to improve outcome and
prevent complications such as claudication and residual limb ischemia
e. Prevention of secondary complications such as venous thrombosis, embolism,
heterotopic bone formation, contracture, and decubitus ulcers is necessary
f. Attention to bone health.
CORE 4 3 Modifiable health risk factors should be assessed and education and treatment strategies to None Reviewed, Recommendation
reduce their impact on morbidity and mortality should be implemented (e.g., smoking Amended 18
cessation, body weight management, diabetes management, hypertension control,
substance abuse).

2007 Module 1
2007 Number
CORE 4 4 In special populations, such as traumatic amputation, upper motor neuron lesions and None Not reviewed,
burns, the risk of heterotopic ossification (HO) should be recognized. Appropriate Deleted
intervention for prevention of HO includes radiation, nonsteroidal medications, and
bisphosphonate medications.
CORE 5 1 A cognitive battery of testing should include: None Reviewed, Deleted
a. Intellectual functioning and attention/concentration along with working memory and
speed of processing
b. Executive functioning
c. Learning and memory: short- and long-term, auditory and visual, recall, and recognition
d. Self (and possibly family) reported cognition and emotional functioning.
CORE 5 2 Testing should be conducted by appropriately trained and certified individuals. None Not reviewed,
Deleted
CORE 5 3 Evaluations should include standardized tests, self-reporting, behavioral descriptions and None Reviewed, Deleted
subjective estimations from family and others, careful history taking, recognition of other
possible comorbid factors (e.g., depression, dementia), and acknowledgment of the
limitations and sources of variability and error in measuring psychometric performance.
CORE 5 4 Neuropsychological referrals should be specific and guided by preliminary mental status None Reviewed, Deleted
assessment by the rehabilitation team. Neuropsychological assessments should focus on the
referring question and not provide specific medical advice.
CORE 6 1 Limb volume management is a critical issue throughout the lifespan of the individual. None Not reviewed,
a. Apply an external compressive device to optimize the limb volume (postoperative rigid Deleted
dressing, ACE wrap, shrinker, liner).
b. Optimize overall fluid management by controlling congestive heart failure, renal failure,
or dialysis treatments.
c. Encourage the patient to maintain a stable body weight.
d. Encourage the patient to wear an external compressive device when the prosthesis is
not worn, especially during the early postoperative and prosthetic phases.
e. Discourage dependent positioning of the residual limb in a wheelchair.

2007 Module 1
2007 Number
CORE 6 2 The patient should be educated about care and management of the residual limb including: None Reviewed, Deleted Recommendation 9
a. Proper application of external compressive devices (ACE wrap, shrinker)
b. Proper donning and doffing technique for the prosthesis
c. Adjustment of prosthetic sock ply for limb volume change, if appropriate
d. Proper hygiene of the residual limb and prosthesis
e. Daily inspection of the residual limb for signs of abnormal pressure distribution
f. Training with a long handled mirror to assist in the inspection of the residual limb.
CORE 6 3 Interventions to prevent contracture at both the hip and the knee should be considered on None Reviewed, New- Recommendations
an ongoing basis, especially in the early postoperative period and when the patient is an replaced 9, 13
intermittent or marginal ambulator.
a. Rigid dressing and knee immobilizers may be considered for the patient with a transtibial
amputation to prevent knee flexion contractures. A number of early postoperative
dressing strategies help to maintain range of motion of the knee.
b. Initiate exercise programs to strengthen the quadriceps and gluteal muscles, along with
active and passive range of motion exercises.
c. Initiate proper positioning and begin a prone lying program. Do not place pillows under
the knee to increase comfort as it increases the chance of contractures forming.
d. Encourage ambulation and weight bearing through the prosthesis.
CORE 6 4 Bony overgrowth may become painful at any stage of its growth and cause significant pain None Not reviewed,
and limitations in prosthetic fittings. Deleted
a. Use preventive measures where necessary in a high-risk population (radiation,
bisphosphanates, NSAIDs).
b. Due to reductions in soft tissue volume, the relative prominence of bony overgrowth
may increase, resulting in the need for prosthetic modifications or replacement.
c. Associated pain may be treated with prosthetic modifications and/or local injections.
d. Surgical excision and possible limb revision is a last resort.
CORE 6 5 Limb protection should be emphasized especially during the early phases when the risk of None Reviewed, New- Recommendation 9
falls is greater. replaced
a. The patient should be instructed to wear an external protective device on the residual
limb.
b. An external protective device may include a postoperative rigid dressing or a
prefabricated rigid dressing.

2007 Module 1
2007 Number
CORE 6 6 Skin and soft tissue should be monitored on a regular basis to detect any mechanical skin None Reviewed, Deleted
injury related to abnormal pressure distribution or signs and symptoms of infection.
a. Abnormal pressure distribution should be prevented by ensuring that the prosthesis is
properly aligned and the prosthetic socket fit is adequate and it should be modified as
needed.
b. Superficial infection (fungal, folliculitis, cellulites), or deep infection (osteomyelitis)
should be treated early and aggressively to prevent deterioration of the residual limb
condition that will have serious impact on the functional mobility of the patient.
CORE 6 7 Patients should be advised that a stable body weight is critical to long-term success. None Reviewed, New- Recommendation
replaced 18
CORE 7 1 Comprehensive assessment of the contralateral limb should include: None Not reviewed,
a. Evaluating for the presence and severity of a sensory deficit Deleted
b. Quantifying the presence and extent of a motor deficit
c. Determining the arterial perfusion status of the extremity
d. Evaluating the presence of deformity
e. Evaluating for signs of acute or chronic abnormal pressure loading, including tissue
redness, ulceration or callosity
f. Inspecting the patient’s footwear, including wear pattern.
CORE 7 2 The patient and/or caregiver should be educated about strategies to protect the skin None Not reviewed,
integrity of the foot (see Appendix D). Deleted
CORE 7 3 Appropriate foot care as indicated should provide: None Not reviewed,
a. Local foot care for callosities and nail care management by a health professional, Deleted
especially in the context of sensory impairment or poor vision
b. Footwear that can be adapted to meet a patient’s mobility needs, and that can
accommodate a foot deformity and/or an orthotic device
c. Orthoses to optimize the pressure distribution on the foot or to substitute for muscle
weakness or spasticity.
CORE 7 4 Regular follow-up to evaluate the adequacy of the footwear or orthosis should be None Not reviewed,
established. Deleted
CORE 7 5 Specialized foot protection devices and/or mattresses should be considered for patients that None Not reviewed,
are confined to bed or spend a considerable amount of time in the recumbent position. Deleted

2007 Module 1
2007 Number
CORE 8 1 Psychosocial functioning should be assessed at each phase of amputation management and B Reviewed, Recommendation 2
rehabilitation. Assessment should focus on current and past symptoms of psychopathology, Amended
particularly depression, anxiety, and post-traumatic stress symptoms. [B]
CORE 8 2 Interventions need to focus particularly on depressive, anxiety and post-traumatic stress B Reviewed, New- Recommendation
disorder (PTSD) symptoms, using empirically supported medical and psychotherapeutic replaced 18
treatments for depression and PTSD. [B] Refer to the VA/DoD Clinical Practice Guidelines on
Major Depressive Disorder in Adults and Post-Traumatic Stress Disorder for management of
these common problems.
CORE 8 3 Effective coping goals/strategies should be developed during psychotherapeutic or B Reviewed, New- Recommendation
counseling interventions. [B] replaced 18
CORE 8 4 During the assessment, examples of effective and ineffective coping strategies should be B Reviewed, New- Recommendation
discussed with the patient, such as enlisting sufficient social support versus social replaced 18
withdrawal and disengagement and problem solving difficulties versus helplessness and
passivity. [B]
CORE 8 5 Specific structured interventions for problems such as depression, anxiety, sexual B Reviewed, New- Recommendation
difficulties, substance abuse or drug overuse, and pain should be considered. [B] replaced 18
CORE 8 6 Interventions may operate through individual, couple, family, or group therapy modalities. B Reviewed, New- Recommendation
[B] replaced 18
CORE 8 7 Significant others should be included in psychotherapeutic and/or psychoeducational B Reviewed, New- Recommendation
interventions as needed. [B] replaced 18

2007 Module 1
2007 Number
CORE 8 8 The use of validated tools for assessment should be considered; some examples may None Reviewed, New- Recommendation
include: replaced 17
a. Prosthesis Evaluation Questionnaire (PEQ) for psychometric assessment is a self-report
questionnaire comprising 10 sub-scales: 4 prosthetic function scales, 2 mobility scales, 3
psychosocial scales, and 1 well-being scale.
b. Trinity Amputation and Prosthetic Experience Scales (TAPES) for psychosocial evaluation
is also a self-report quality of life questionnaire with nine sub-scales; 3 psychosocial
scales, 3 activity restriction scales, and 3 satisfaction subscales. TAPES has the advantage
of being able to predict residual limb pain, phantom limb pain, and the extent of
prosthetic use.
c. The Hospital Anxiety and Depression Scale (HAD) is a 14-item highly sensitive brief
screening for anxiety and depression, commonly used in hospital settings.
d. The SF-36 Health Survey measures the degree of burden or dysfunction a medical
condition has in a patient’s life.
CORE 8 9 Psychological components to multidisciplinary approaches to chronic pain management B Reviewed, New- Recommendation
should be included as needed. [B] replaced 18
CORE 9 1 A baseline assessment should be obtained and continuously updated throughout the None Reviewed, New- Recommendation 2
rehabilitation phases. The assessment should include information about the existing social replaced
environment and support system:
Interpersonal Social Environment
a. Family and extended family
b. Community - including workplace, employers/employees and co-workers
c. Spiritual, religious, and cultural support
d. Peer support system (see Core-10: Peer Support Interventions)
Physical Environment
a. Home environment – hazards and need for modification to address safety and
accessibility
b. Workplace
c. Community – geographical location, distance from resources and services, and access to
resources
Economic Environment
a. Sources of income and/or financial support.

2007 Module 1
2007 Number
CORE 10 1 Peer visitation strategies may be considered throughout the rehabilitation cycle, particularly C Reviewed, Recommendation 6
early when anxiety and adjustment problems may be most pronounced. [C] Amended
CORE 10 2 Peer support interventions may be a particularly useful aspect of pre-procedural patient C Not reviewed, Recommendation 6
education interventions. [C] Deleted
CORE 10 3 Peer visitation volunteers should receive structured training prior to performing peer C Reviewed, Deleted
visitation services. The Amputee Coalition of America (ACA) provides a reputable training
certification program. [C]
CORE 10 4 Patients should be referred to peer support groups or similar resources, if available. [I] I Reviewed, Recommendation 6
Amended
CORE 11 1 Pre-procedural educational interventions should be provided to the patient before B Reviewed, New- Recommendation 1
amputation, if possible, in order to decrease his/her fear, anxiety, and distress and to replaced
improve his/her post-procedural recovery. [B]
CORE 11 2 All members of the rehabilitation team should be involved in patient education as part of C Reviewed, Recommendation 1
their interaction with the patient. [C] Amended
CORE 11 3 Pre-procedural educational interventions should generally include information and a B Reviewed, Deleted Recommendation 1
description of the specific procedures and events the patient will experience at the various
phases of treatments, and continue throughout the continuum of care. [B]
CORE 11 4 Educational interventions should also include sensory information, that is a description of B Reviewed, Deleted
sensations and other feelings/symptoms the patient may experience at various stages
during and following the procedure. [B]
CORE 11 5 Educational interventions may also include coping skills training; cognitive behavioral coping B Reviewed, Deleted
strategies are likely to be the most effective strategies. [B]
CORE 11 6 General supportive counseling (e.g., eliciting and validating the patient’s anxieties, fears, and C Reviewed, Deleted
concerns) may also be helpful. Open-ended questioning, active listening techniques, eliciting
anticipation of future stressors, and eliciting and encouraging utilization of the patient’s
social support resources are important strategies irrespective of whether information-giving
or coping skills training interventions are being used. [C]
CORE 12 1 Prior to the learning assessment, the health professional should assess the patient with a None Reviewed, Deleted
lower limb amputation for core concerns, potential fears, support limitations, and cultural
history.

2007 Module 1
2007 Number
CORE 12 2 The best time to begin a learning assessment is determined on a case-by-case basis but None Reviewed, Deleted
often begins with the initial contact with the patient who has had a lower limb amputation
and their family.
CORE 12 3 The learning assessment should use open-ended questions to obtain the following and None Reviewed, Deleted
additional, information:
a. Patient/family’s ability to cope with the health status, plan of care, prognosis, and
outcome
b. Patient/family needs, concerns, roles, and responsibilities
c. Specific learning needs (knowledge, attitudes, skills) and educational level
d. Barriers to learning, including physical and/or cognitive limitations, language, emotional
or psychological, and financial difficulties
e. Readiness to learn
f. Patient preferences regarding learning methods.
CORE 13.1 1 The residual limb should always be properly positioned to avoid contractures that could None Reviewed, Deleted
interfere with future prosthetic fit and ambulation. In a transtibial amputation, the residual
limb should be placed in knee extension when in bed. For a transfemoral or transtibial
amputation, the residual limb should be kept in neutral alignment for adduction/abduction
and internal/external rotation. At no time should a pillow be placed under the residual limb.
CORE 13.1 2 A prone lying program should be initiated with all patients who have a lower extremity None Reviewed, Deleted
amputation to avoid hip flexion contractures. Progressively advance the length of time from
the patient’s tolerance to 30 minutes twice per day if possible. (See Table 2. Summary of
Interventions in Rehabilitation Phases for detailed interventions by phases of care.)
CORE 13.2 1 A strengthening program should be initiated for the major muscle groups of the upper None Reviewed, New- Recommendation
extremities, trunk, and the residual and contralateral limbs in order to maximize functional replaced 14
use of the prosthesis and prevent the development of comorbidities such as low back pain.
CORE 13.2 2 Both open and closed-chain exercises and isokinetic and progressive resistance exercises None Reviewed, New- Recommendation
should be included in the strengthening program. replaced 14
CORE 13.2 3 Specific muscle groups to strengthen include hip extensors, hip adductors, hip abductors, None Reviewed, Deleted
abdominal musculature, back musculature, knee extensors, rotator cuff, and elbow
extension.
CORE 13.2 4 A home exercise program should be designed and tailored to a patient’s individual needs for None Reviewed, Deleted
use on a long-term basis.

2007 Module 1
2007 Number
CORE 13.3 1 A tailored cardiovascular training program should be initiated as soon as possible in the None Reviewed, Deleted
postoperative phase and continue throughout the rehabilitation process.
CORE 13.3 2 The cardiovascular program should include upper body ergometry regardless of the ability None Reviewed, Deleted
to use a lower extremity prosthesis.
CORE 13.3 3 Gait training should progress from use of an appropriate assistive device and increase to None Reviewed, New- Recommendation
community distances as cardiovascular fitness improves. replaced 14
CORE 13.3 4 Consultation to a cardiac rehabilitation program should be considered, particularly in None Reviewed, Deleted
patients with known cardiopulmonary disease or dysvascular amputation.
CORE 13.3 5 Higher level sporting activities should be pursued to supplement routine cardiovascular None Reviewed, Deleted
fitness in younger individuals with traumatic amputation.
CORE 13.4 1 Sitting and standing balance should be assessed throughout the rehabilitation process using None Reviewed, New- Recommendation
standardized assessment tools such as the Berg or Tinetti Balance Assessment. replaced 17
CORE 13.4 2 Interventions should start with sitting balance and progress to sitting weight shifts, then sit None Reviewed, Deleted
to stand, supported standing, single-limb balance, and dynamic balance training.
CORE 13.4 3 Balance should be challenged with a variety of activities such as weight shifting on a soft None Reviewed, Deleted
surface, rocker board, ball rolling under the sound foot, and step-ups.
CORE 14.1 1 The self-care component of functional ADL should include dressing, feeding, grooming, None Reviewed, Deleted
bathing, and toileting, with and without a prosthesis.
CORE 14.1 2 The transfers component of functional ADL should include the following, with and without a None Reviewed, Deleted
prosthesis:
a. sit to stand
b. bed to chair
c. chair to toilet
d. chair to tub
e. vehicle transfers
f. floor transfers.
CORE 14.1 3 Patients should be educated in strategies to prevent falls and improve safety. None Reviewed, Deleted

2007 Module 1
2007 Number
CORE 14.2 1 Standardized measures of mobility can assist with outcome measurement and determine None Reviewed, New- Recommendation
additional social support and equipment needs. Consider utilizing one or more of the replaced 16
following measures, but note that they may not be helpful in the young active individual
with traumatic amputation (see Table 8. Advantages and Disadvantages of Recommended
Assessment Tools):
a. Amputee Mobility Predictor (AMP)
b. Functional Independence Measure (FIM)
c. Two-Minute Walk Test
d. Timed Up and Go Test (TUG)
e. Upper Extremity Ergometry.
CORE 14.2 2 The training program to improve mobility should include both the physical components of None Reviewed, New- Recommendation
strengthening and cardiovascular fitness and practicing the actual activity. replaced 14
CORE 14.2 3 Assistive devices (e.g., combination of canes, crutches, walkers, and manual and/or powered None Reviewed, New- Recommendation
mobility) that the patient has demonstrated to be able to use safely and which improve the replaced 11
ability to navigate different environments should be prescribed.
CORE 14.2 4 A wheelchair should be prescribed for individuals with amputations who may experience None Reviewed, New- Recommendation
times when they can not use their prosthesis(es) and/or assistive devices for mobility. replaced 11
CORE 14.2 5 Advanced wheelchair mobility skills should be taught to navigate such environments such as None Reviewed, New- Recommendation
stairs, escalators, curbs, uneven terrain, and soft surfaces (grass, sand, gravel). replaced 11
CORE 14.2 6 Vehicle modifications should be prescribed for those who can not safely drive a vehicle due None Not reviewed,
to right lower limb amputation, or left lower limb amputation with comorbidities to the right Deleted
lower limb, or any individual with bilateral lower extremity amputations.
CORE 14.3 1 Training in the use of public transportation, with and without a prosthesis, should be None Reviewed, Deleted
provided, if appropriate.
CORE 14.3 2 Endurance should be increased with ambulation to community distances if appropriate. None Reviewed, Deleted
CORE 14.3 3 Information on organizations with opportunities for adaptive recreational activities should None Not reviewed,
be provided. Deleted
CORE 14.3 4 Driver’s training and vehicle modifications should be pursued, if not already done. Any None Reviewed, Deleted
patient with a right lower extremity amputation should be evaluated and trained on a left
foot accelerator. A patient with bilateral lower extremities amputation should be evaluated
and trained in hand controls.

2007 Module 1
2007 Number
CORE 14.3 5 The patient’s home should be evaluated for accessibility and information on home None Not reviewed,
modifications should be provided. Deleted
CORE 14.3 6 Patient’s worksite should be evaluated for the potential need for accommodations to None Not reviewed,
facilitate return to the work setting. Deleted
CORE 14.3 7 Patients should be provided with a list of resources for information regarding amputations, None Reviewed, Deleted
support groups, and accessibility for people with disabilities.
A 1 1 Amputation should only be considered if the limb is non-viable (gangrenous or grossly None Not reviewed,
ischemic), dangerous (malignancy or infection), or non-functional. Deleted
A 2 1 Consider urgent surgery in severe life-threatening situations including infection and trauma. None Not reviewed,
Deleted
A 3 1 A thorough medical assessment should be completed preoperatively to evaluate the None Not reviewed,
patient’s physical condition, nutrition, infection, neuropsychiatric impairment, and bowel Deleted
and bladder function as well as a review of systems (cardiovascular, respiratory, endocrine,
skin, neurological, and musculoskeletal).
A 3 2 Condition and function of the contralateral limb should be assessed including (see CORE-7: None Not reviewed,
Contralateral Limb): Deleted
a. Quantify the severity of the sensory deficit
b. Observe for the presence of deformity
c. Observe for signs of abnormal soft tissue loading
d. Limb perfusion
e. Education, specialized heel protectors, or specialized mattresses should be used to
assure that the patient does not develop ulceration on the remaining limb.
A 3 3 Baseline function should be evaluated prior to amputation surgery (see CORE-13: Physical None Not reviewed,
Rehabilitation and CORE-14: Functional Rehabilitation): Deleted
a. Range of motion (ROM)
b. Strength
c. Exercise endurance
d. Balance
e. Mobility
f. Activities of daily living (ADL).

2007 Module 1
2007 Number
A 3 4 Pain control measures should be initiated in the preoperative period to optimize the None Reviewed, New- Recommendation 3
postoperative rehabilitation (see CORE-3: Pain Management). replaced
A 3 5 A psychological assessment and preparation strategies should be completed in the None Reviewed, New- Recommendation 2
preoperative phase whenever possible (see CORE-8: Behavioral Health Assessment and replaced
Treatment).
A 3 6 A preoperative cognitive assessment should be conducted to assist in the process of None Reviewed, New- Recommendation
determining the patient’s ability to learn, adapt to, and utilize a prosthesis following surgery replaced 10
as well as the ability to participate in rehabilitation and to maximize functional
independence and community reintegration (see CORE-5: Cognitive Assessment).
A 3 7 Patient’s goals and priorities should be assessed prior to amputation surgery. None Reviewed, New- Recommendation
replaced 10
A 3 8 Assess patient’s social environment, home and community environments, and support None Reviewed, New- Recommendation 2
system (see CORE-9: Social Environment). replaced
A 4 1 A unified, cohesive, and comprehensive treatment plan should be developed prior to None Not reviewed,
surgery that includes specific interventions for treatment by the interdisciplinary Deleted
rehabilitation team members and updated throughout the full continuum of care. (see CORE
2: Rehabilitation Treatment Plan).
A 5 1 When possible, every effort should be made to correct controllable factors prior to None Not reviewed,
undertaking surgical amputation, including (see CORE-4: Medical Care): Deleted
a. Cardiovascular
b. Pulmonary
c. Metabolic
d. Nutrition
e. Psychiatric illness
f. Risk factor reduction (including cardiovascular risk and diabetes mellitus risk reduction)
A 6 1 Initiate appropriate rehabilitation interventions while the patient is awaiting amputation None Reviewed, Deleted
surgery, to maintain current function and prevent secondary complications (see CORE-13:
Physical Rehabilitation; CORE-14: Functional Rehabilitation).

2007 Module 1
2007 Number
A 7 1 A discharge plan should be initiated early in the pre-operative period and updated None Not reviewed,
throughout the rehabilitation process to address: Deleted
a. Location of rehabilitation
b. Social support/financial resources
c. Home environment assessment
d. Transportation
e. Vocational considerations
f. Durable medical equipment (DME).
A 8 1 A learning assessment and identification of barriers to learning or communication should be None Reviewed, New- Recommendation
performed preoperatively. replaced 10
A 8 2 Patients scheduled for amputation should receive education regarding the procedure and None Reviewed, New- Recommendation 1
the various components of postoperative care and rehabilitation activities, including (see replaced
CORE-11: Patient Education):
a. Pain control
b. Patient safety/fall precautions
c. Prevention of complications
d. Procedural/recovery issues:
• Level of amputation
• Prosthetic options
• Postoperative dressing
• Sequence of amputation care
• Equipment
e. Expectation for functional outcome
f. Potential psychosocial issues
g. Role of the rehabilitation team members.
A 9 1 Based on a clinical evaluation by the treating surgeon with input from the interdisciplinary None Reviewed, Recommendation 7
rehabilitation team, the patient (or person giving consent) should be presented with all Amended
viable treatment options and the risks and benefits for the following:
a. Level of amputation
b. Management of postoperative wound
c. Type of postoperative prosthesis.

2007 Module 1
2007 Number
A 9 2 The patient (or person giving consent) should be encouraged to ask questions. The surgeon None Reviewed, Deleted
should make every effort to answer those questions to the patient’s satisfaction. The patient
(or person giving consent) should be able to verbalize a good understanding of their
treatment options at the end of the process.
A 9 3 Involvement of the patient’s family and/or significant others should be encouraged. None Not reviewed,
Deleted
A 9 4 The patient (or person giving consent) must agree to the surgical and immediate post- None Not reviewed,
surgical treatment plan. Deleted
A 9 5 The informed consent process should be in compliance with institutional policy (satisfying None Not reviewed,
The Joint Commission’s requirements). Deleted
A 10.1 1 The choice of amputation level should take in consideration the risks and benefits. The None Reviewed, Recommendation 7
factors in the risk-benefit assessment include the patient’s goals and priorities, the patient’s Amended
general condition and risk of additional surgeries, the potential for healing of the limb, and
the predicted probable functional outcome.
A 10.1 2 Optimal residual limb length: None Reviewed, Deleted
a. Transtibial
• Optimum – length that allows space for the prosthetic foot and sufficient muscle
padding over the residual limb – typically mid-tibia
• Minimum – junction of middle third and proximal third of tibia just below the flair of
the tibial plateau to allow sufficient tibia for weight-bearing.
b. Transfemoral
• Optimum – length that allows space for an uncompromised knee system – typically
just above the condylar flair
• Minimum – junction of middle third and proximal third (below the level of the lesser
trochanter) to allow sufficient femur length/lever arm to operate the prosthesis.
c. If there is uncertainty of the optimal length of the residual limb, preoperative
consultation with an experienced physiatrist or prosthetist should be considered.

2007 Module 1
2007 Number
A 10.1 3 The potential for wound healing should be determined. The following may be considered: [I] I Reviewed,
a. Laboratory studies: Amended
• C-reactive protein to check for infection
• Hemoglobin to check for treatable anemia to ensure an appropriate oxygenation
level necessary for wound healing
• Absolute lymphocyte count to check for immune deficiency and/or infection
• Serum albumin/prealbumin level to check for malnutrition and diminished ability to
heal the wound.
b. Imaging studies:
• Anteroposterior and lateral radiography of the involved extremity
• CT scanning and MRI as necessary
• Doppler ultrasonography to measure arterial pressure.
c. Additional tests:
• Ischemic index (II) is the ratio of Doppler pressure at the level being tested to the
brachial systolic pressure – a II of 0.5 or greater at the surgical level is necessary to
support healing.
A
• Assess preoperative amputation TcPO2 levels – preoperative levels greater than
20mmHg are associated with successful healing after amputation. [A]
A 10.2 1 The appropriate postoperative dressing should be determined by the surgeon before I Reviewed, Deleted
surgery, recognizing that circumstances occurring during the surgery may necessitate
changes. [I]
A 10.2 2 Consider the use of a rigid or semi rigid dressing to shorten the time to healing and B Reviewed, Recommendation 9
readiness for prosthesis in dysvascular transtibial amputations. [B] Amended
A 10.2 3 There is inconclusive evidence to recommend for or against a specific kind of rigid I Reviewed, Deleted
dressing. [I]
A 10.2 4 Properly fitted shrinkers should be used as soon as possible, after amputation. [I] I Reviewed, Deleted
A 10.2 5 Patients with a bulbous transtibial limb are more likely to do better with a rigid dressing I Reviewed, Deleted
applied above the knee and changed every three to five days until they are able to tolerate a
shrinker. [I]
A 11.1 1 Perform the appropriate amputation at the selected level, adhering to good surgical and None Not reviewed,
amputation principles. Deleted

2007 Module 1
2007 Number
A 11.2 1 Appropriate postoperative dressing should be applied after amputation. None Not reviewed,
Deleted
A 11.2 2 The use of rigid postoperative dressings should be considered (which is preferred in B Reviewed, Recommendation 9
situations where limb protection is the priority). [B] Amended
B 2 1 The postoperative plan should include a care plan to address: None Not reviewed,
a. Medical requirements Deleted
b. Wound or surgical requirements
c. Rehabilitation requirements including:
• Prevent contractures
• Reduce postoperative edema through the use of compression therapies
• Protect the amputated limb from external trauma
• Ensure patient safety
B 3 1 For a closed amputation and primary closure, the following procedures should be None Not reviewed,
performed: Deleted
a. May apply sterile, non-adherent dressing secured with stockinet
b. Apply a compressive dressing to reduce edema and shape the residual limb
c. Monitor for infection
d. Remove the sutures or staples per the advice of the surgeon
B 3 2 For an open amputation, the following procedures should be considered: None Not reviewed,
a. Staged closure at a later date may be required for wounds heavily contaminated from Deleted
infection or trauma
b. A vacuum-assisted-closure devise may be helpful for open wounds
B 3 3 Residual limb management should continue with the focus on postoperative dressings, None Reviewed, New- Recommendation 9
control of the edema and shaping of the residual limb, control of the pain, and protection of replaced
the residual limb from further injury. (See CORE-6 : Residual Limb)
B 4 1 A thorough medical assessment should be completed postoperatively to assess physical None Not reviewed,
condition, nutrition, lack of infection, and bowel and bladder function as well as a review of Deleted
systems (cardiovascular, respiratory, endocrine, skin, neurological, and musculoskeletal).

2007 Module 1
2007 Number
B 4 2 Treatment of pain should be started immediately and address the specific source of pain: None Reviewed, Deleted
a. Post surgical pain – appropriate edema control, liberal use of narcotics
b. Neuropathic/phantom pain – consider use of anticonvulsant (e.g., pregabalin,
gabapentin, antidepressants (e.g., SSRIs, or TCAs)
c. Consider use of epidural or regional anesthesia.
B 4 3 Specific measures for deep vein thrombosis (DVT) and pulmonary embolism (PE) prophylaxis None Not reviewed,
should be applied. Deleted
B 4 4 A nutrition assessment should be documented and specific recommendations should be None Not reviewed,
applied; referral to a nutrition specialist should be considered. Deleted
B 4 5 A thorough sepsis workup for any signs/symptoms of systemic infection should be None Not reviewed,
completed. Deleted
B 4 6 Medical and surgical comorbidities resulting from polytrauma, such as that seen in combat None Reviewed, New- Recommendation
casualties, are best managed in rehabilitation centers that provide interdisciplinary replaced 12
management including multiple medical and surgical subspecialties with trauma experience.
B 4 7 Bowel and bladder functions should be monitored to maintain fluid balance as well as to None Not reviewed,
avoid urinary retention and constipation, which may be brought on by medications Deleted
(particularly opioids and anticholinergics) and/or decreased mobility.
B 4 8 Behavioral health support should be provided as necessary. I Reviewed, Deleted
B 4 9 The following rehabilitation interventions should be initiated as tolerated: None Reviewed, Recommendation
a. Range of motion (ROM) Amended 14
b. Strengthening
c. Cardiovascular fitness and endurance
d. Balance
e. Mobility
f. Functional activities and ADL.
B 4 10 Patient and family education on positioning, skin care, and pain management; preservation None Reviewed, Deleted
of the intact limb; and approaches to modify risk factors should be re-enforced from
preoperative training.

2007 Module 1
2007 Number
B 5 1 Patients undergoing lower limb amputations should be assessed using a standardized None Reviewed, Recommendation
approach like the one described in Table 9. Categories of Wound Healing (adapted from Amended 18
Smith, 2004). The depth and extent of involvement of the non-healing and nonviable skin,
subcutaneous tissues, muscle, and/or bone will assist in the evaluation and treatment of
problematic wounds.
B 6 1 Early revision surgery may be considered for wounds that are slow to heal, particularly in None Not reviewed,
Category III, IV, and V wounds. Deleted
B 6 2 Early vascular evaluation may be considered for patients with delayed healing and None Not reviewed,
consultation for vascular intervention may be considered for patients with impaired Deleted
peripheral arterial blood flow.
B 6 3 Early evaluation and treatment for potential superficial and deep infections may be None Not reviewed,
considered for patients with delayed healing. The evaluation may include wound cultures, Deleted
laboratory studies, and radiological studies. Debridement, intravenous antibiotics, and/or
revision may be necessary to achieve infection control.
B 6 4 Early aggressive local wound care should always be initiated for any degree of wound None Reviewed, Deleted
breakdown. This may include the use of topical agents (regranex, aquacel silver, panafil)
B 6 5 Hyperbaric oxygen can be considered as an adjunct treatment for impaired wound healing. None Reviewed, Deleted
B 7 1 Medical status should be assessed prior to proceeding to another level of care. The following None Not reviewed,
criteria must be met prior to discharge to the next level of care: Deleted
a. Hemodynamically stable
b. Lack of systemic infection or an appropriate course of treatment in place
c. Stable surgical site
d. Acceptable bowel and bladder management
e. Comorbid conditions addressed.
B 8 1 Rehabilitative placement following a lower limb amputation should be based on the None Reviewed, New- Recommendation
patient’s medical status, current and anticipated function, ability to participate in replaced 12
rehabilitation interventions, social support system, and community resources.
B 8 2 To be discharged from acute care the patient’s medical condition needs to be stable. None Not reviewed,
Deleted

2007 Module 1
2007 Number
B 8 3 Patients are able to be discharged to home when: None Not reviewed,
 Medically stable Deleted
 Able to be mobile and transfer with available social support systems utilizing appropriate
assistive devices (walker, cane, wheelchair)
 Able to perform basic daily living skills independently or have a social support system to
compensate for the deficiencies
 There is an accessible home environment
 There is access to continued rehabilitation interventions as needed.
B 8 4 Patient who do not meet criteria for discharge to home may be referred to: None Reviewed, New- Recommendation
a. Acute inpatient rehabilitation care when: replaced 12
• Able to follow a minimum of two-steps commands
• Able to actively participate and benefit from at least two hours of therapy per day.
b. Sub-acute rehabilitation care or an extended nursing facility when:
• Able to follow single step commands
• Able to actively participate in less than two hours of therapy per day.
B 8 5 Patients not meeting the criteria for discharge to a rehabilitation program (e.g., they do not None Not reviewed,
meet the above cited criteria and nursing care outweighs rehabilitation care) may be Deleted
discharged to a program that is primarily focused on skilled nursing care when:
a. Medically stable
b. Able to tolerate only a few hours of therapy per week.
C 2 1 A thorough medical assessment should be completed upon admission to rehabilitation to None Not reviewed,
include: cardiovascular, pulmonary, endocrine, neurological, bowel and bladder, skin and Deleted
musculoskeletal.
C 2 2 Special attention should be taken to assess the health of the contralateral leg and foot None Not reviewed,
including vascular health, sensation, presence of deformity, abnormal skin or other tissue, Deleted
and appropriate footwear.
C 2 3 Assess the healing of the wound by monitoring: None Not reviewed,
a. Wound closure Deleted
b. Drainage or seepage
c. Excessive redness or induration around the wound site
d. Temperature of the surrounding tissue

2007 Module 1
2007 Number
C 2 4 Involve the surgeon in problems with wound healing and wound management regardless of None Not reviewed,
the patient’s disposition. Deleted
C 2 5 Consult the specialized wound care team as needed. None Not reviewed,
Deleted
C 2 6 Protect the residual limb from external trauma to reduce potential complications, delayed None Reviewed, New- Recommendation 9
wound healing and encourage mobility. replaced
C 2 7 Residual limb management should continue with the focus on control of edema, shaping the None Reviewed, New- Recommendation 9
residual limb and control of the pain. (See CORE-6: The Residual Limb) replaced
C 2 8 Postoperative physical and functional assessment should be performed after amputation None Not reviewed,
surgery and prior to postoperative rehabilitation. Include the following: Deleted
a. Patient history, including
• Past medical history
• Home environment
• Premorbid functional level – ADL, mobility, and cognition
• Social environment (see Core-9: Social Environment [Support])
b. Physical assessment, including:
• Range of motion (ROM) – bilateral hips, knees, and upper extremities
• Strength – upper extremities and lower extremities
• Sensation – involved limb and contralateral limb
• Proprioception – involved limb and contralateral limb
• Balance – sitting and standing
c. Functional assessment including:
• Mobility – current level of function and use of assistive devices (bed, transfers,
ambulation)
• Basic ADLs – eating, grooming, toileting, bathing, and dressing
d. Screen for other impairments (e.g., vision and hearing, or other trauma)

2007 Module 1
2007 Number
C 2 9 Consider using standardized measures at admission and discharge to demonstrate progress None Reviewed, New- Recommendation
and the efficacy of the rehabilitation process. The recommended tools for assessment replaced 16
include:
a. Amputee Mobility Predictor (AMP)
b. Functional Independence Measure (FIM)
c. Two-Minute Walk
d. Timed Up and Go Test (TUG)
e. Upper Extremity Ergometry
(See CORE-14.2: Mobility and Equipment)
C 2 10 Pain assessment should be performed by all members of the rehabilitation team. None Not reviewed,
Deleted
C 2 11 Patients should be assessed for pain and treatment should be based on etiology and None Reviewed, New- Recommendation 3
initiated/continued to optimize rehabilitation. replaced
C 2 12 Consider prophylactic pain management prior to the rehabilitation session. (See CORE-3: None Not reviewed,
Pain Management) Deleted
C 2 13 A psychological assessment should be completed if not done preoperatively. None Reviewed, New- Recommendation 2
replaced
C 2 14 Continuous monitoring of behavioral health should be performed by all members of the None Not reviewed,
rehabilitation team. (See CORE-8: Behavioral Health Assessment and Treatment) Deleted
C 2 15 A postoperative cognitive/neuropsychological assessment should be conducted if not None Reviewed, Recommendation
completed preoperatively. (See CORE-5: Cognitive Assessment) Amended 10
C 3 1 Members of the rehabilitation team should work with the patient to establish goals specific None Not reviewed,
to their area of expertise. Deleted
C 3 2 Goals should be written, be measurable, and be specific. None Not reviewed,
Deleted

2007 Module 1
2007 Number
C 4 1 The following conditions, if present, require aggressive management: None Reviewed, New- Recommendation
a. Hyperglycemia replaced 18
b. Cardiac, respiratory, renal, and metabolic
c. Nutritional deficiency
d. Major psychiatric illness
e. Vascular lesions.
(See CORE-4: Medical Care)
C 5 1 During the pre-prosthetic rehabilitation phase the following should be covered with the None Reviewed, Deleted
patient:
a. Positioning
b. Rehabilitation process
c. Pain control
d. Residual limb care
e. Prosthetic timeline
f. Equipment needs
g. Coping methods
h. Prevention of complications
i. Safety and fall prevention (essential).
(See CORE-11: Patient Education)
C 6 1 Rehabilitation goals should be documented in the treatment plan. None Not reviewed,
Deleted
C 6 2 The treatment plan should be updated by the rehabilitation team to reflect changes in the None Not reviewed,
patient’s status. (See CORE-2: Rehabilitation Treatment Plan) Deleted

2007 Module 1
2007 Number
C 7 1 Provide physical and functional rehabilitation interventions in the following: None Reviewed, Deleted
a. Residual limb management (teach care of the residual limb and the use of ACE wrap and
shrinkers)
b. Range of motion (ROM) (residual and contralateral limbs at the hip and knee)
c. Strengthening (add trunk and core stabilization exercises; initiate a home exercise
program)
d. Cardiovascular endurance (tailored to patient’s fitness level and progressed as tolerated)
e. Balance (progress program to dynamic balance training).
(See CORE-13: Physical Rehabilitation and CORE-14: Functional Rehabilitation)
C 7 2 Provide interventions to evaluate and promote community reintegration: None Reviewed, Deleted
a. Home evaluation and modification
b. Mobility (progress single limb gait from the parallel bars to the use of an appropriate
assistive device)
c. Equipment (independent wheelchair mobility)
d. Functional activities and ADL
e. Driver’s training and vehicle adaptation
f. Vocational rehabilitation or return to school
g. Recreation activities without a prosthesis.
(See CORE-14: Functional Rehabilitation)
C 8 1 Patient’s candidacy for a prosthesis should be determined by the rehabilitation team based None Not reviewed,
on the patient’s characteristics, goals, and an objective evaluation of their functional status. Deleted
Some areas to be considered:
a. Patient is willing and motivated to move forward for prosthetic rehabilitation
b. Patient has the ability to understand and apply knowledge to the fitting and use of a
prosthesis
c. Contralateral limb will tolerate weight bearing
d. Patient is in adequate physical condition to tolerate walking with a prosthesis
e. Prosthesis contributes to quality of life or self image.
C 9 1 Additional equipment to facilitate mobility and ADL is required for a patient with a lower None Reviewed, New- Recommendation
extremity amputation. replaced 11
C 9 2 The type of equipment should be based on the current and anticipated functional status. None Reviewed, Deleted

2007 Module 1
2007 Number
D 1 1 Patients at K level “0” are not recommended for prostheses for ambulation or transfers. None Not reviewed,
Deleted
D 1 2 Patients a K level “1” are recommended for prostheses that meet the functional goals of None Not reviewed,
limited and unlimited household ambulation. Deleted
D 1 3 Patients at K level “2” are recommended for prostheses that meet the functional goals of None Not reviewed,
limited community ambulation. Deleted
D 1 4 Patients at K level “3” are recommended for prostheses as community ambulators with the None Not reviewed,
ability to traverse most environmental barriers and may have vocational, therapeutic, or Deleted
exercise activity that demands prosthetic utilization beyond simple locomotion.
D 1 5 Patients at K level “4” are recommended for prostheses at the highest level of functioning None Not reviewed,
typical of the child, active adult, or athlete. Deleted
D 1 6 Prosthetic fittings typically should not begin until the suture line has completely healed, None Not reviewed,
although in unusual circumstances prosthetic fitting and limited ambulation may start with a Deleted
clean non-infected wound with granulation tissue.
D 2 1 The prescription for a patient with a transmetatarsal amputation should include: None Not reviewed,
a. Toe filler/arch support Deleted
b. Custom/prefabricated Ankle-foot orthosis (AFO) with toe filler:
c. Assessment adequate shoe fit
D 2 2 The prescription for a patient with a transtibial/transfemoral amputation should include: None Not reviewed,
a. Socket Deleted
b. Socket interface
c. Suspension mechanism
d. Pylon
e. Knee joint
f. Foot/ankle.
(See Appendix C for a listing of specifications.)

2007 Module 1
2007 Number
D 3 1 Initiate physical and functional interventions for prosthetic training as appropriate for the None Reviewed, New- Recommendation
patient’s functional goals: replaced 14
a. Residual limb management (donning and doffing of prosthesis, gel liners or socks as
appropriate)
b. Range of motion (ROM)
c. Strengthening
d. Cardiovascular fitness and endurance
e. Balance
f. Mobility
g. Functional activities and ADL
h. Equipment
i. Driver’s training
j. Home evaluation
k. Home exercise program
l. Community integration.
D 3 2 A two-phase process may be considered for prosthetic fitting and training: None Not reviewed,
a. Phase One: Preparatory (preliminary) prosthesis Deleted
b. Phase Two: Definitive prosthesis.
D 3 3 If only a definitive prosthetic is to be fitted, the fitting for the socket should be delayed until None Not reviewed,
the residual limb is fully mature (usually three to four months) or until general stabilization Deleted
occurs in the patient's weight and residual limb volume.
D 4 1 Once basic prosthetic management has been completed, the focus should move to weight None Reviewed, Deleted
bearing with the prosthesis, standing balance, weight shifts, and equalization of step length.
D 4 2 Once the patient has mastered prosthetic ambulation with a walker or other assistive None Reviewed, Deleted
device, training on stairs, uneven surfaces, and ramps/inclines are recommended.
D 4 3 Prosthetic gait training should incorporate aspects related to the patient’s home, work, None Reviewed, New- Recommendation
and/or recreational environments. replaced 14

2007 Module 1
2007 Number
D 5 1 Initial patient education in the use of a prosthetic lower limb should include: None Not reviewed,
a. Demonstration and training in donning and doffing the prosthesis (dependent upon the Deleted
type of prosthesis provided)
b. Initial training in how to start ambulation (dependent upon the type of prosthesis
provided)
c. Instruction in accomplishing safe transfers taking in consideration the home
environment
d. Instruction in how to fall safely and get back up
e. Instruction in daily self inspections of the residual limb for excessive tissue loading; if
erythema is present upon removing the prosthesis and does not completely resolve in 20
minutes, the patient should be instructed to report it immediately
f. Basic residual limb and prosthetic hygiene.
D 5 2 If appropriate, the patient’s caregiver should also be instructed in management and care of None Not reviewed,
the prosthesis, proper transfer technique and safety. Deleted
D 6 1 Patients who were not prosthetic candidates or candidates for a transfer prosthesis should None Not reviewed,
be evaluated periodically to determine if their functional goals may be expanded to include Deleted
ambulation.
D 6 2 Patients with a prosthesis should be advised to report any of the following symptoms as None Reviewed, Deleted
they are signs that the prosthesis needs to be modified:
a. Ongoing pain
b. Skin breakdown
c. Change in the ability to don and doff the prosthesis
d. Change in the number of sock plies
e. Change in the pattern of usage
f. Change in functional needs or goals.
D 6 3 The prosthesis should be assessed at least once within the first year of prosthetic use to None Not reviewed,
address: Deleted
a. Stability
b. Ease of movement
c. Energy efficiency
d. Appearance of the gait to determine the success of fitting and training.

2007 Module 1
2007 Number
D 6 4 Patients presenting with dermatologic problems require assessment and intervention: None Not reviewed,
a. Contact dermatitis: assess the hygiene of the liner, socks, and suspension mechanism Deleted
b. Cysts and sweating: assess for excessive shear forces and improperly fitted components
c. Scar management: requires massaging and lubricating the scar to obtain a well-healed
result without dog ears or adhesions
d. Superficial fungal infections are common and will require topical anti-fungal agents for
resolution.
D 7 1 Additional equipment to facilitate mobility and ADL should be provided after lower None Reviewed, New- Recommendation
extremity amputation with or without a prosthesis. replaced 11
D 7 2 The type of equipment should be based on the current and anticipated functional status. None Reviewed, New- Recommendation
replaced 11
E 2 1 Patients with a prosthesis should visit the Amputation Clinic Team for an initial None Not reviewed,
comprehensive visit to address any change in the condition of the residual limb. Deleted
E 2 2 Patients with minor repairs or adjustments to the prosthesis should visit a prosthetic None Not reviewed,
laboratory. Deleted
E 2 3 Patients with a change in their medical condition should be seen by a primary care provider None Not reviewed,
or physiatrist, in addition to their comprehensive follow-up with the Amputation Clinic Deleted
Team.
E 2 4 A follow-up appointment should be made at the time of the comprehensive visit with the None Not reviewed,
appropriate clinic or provided at the patient’s request, after a major medical or functional Deleted
change, or after a referral/consultation is received.
E 2 5 Patients with a lower limb amputation who are not prosthetic users should be seen by their None Not reviewed,
primary care provider to manage comorbidities, evaluate medical risks, and maintain the Deleted
health of the residual and contralateral extremity.
E 2 6 If the function of a non-prosthetic user changes and he/she becomes a prosthetic candidate, None Not reviewed,
an appointment should be made with the Amputation Clinic Team for consideration of Deleted
prosthetic restoration.

2007 Module 1
2007 Number
E 3 1 The follow-up assessment for a prosthetic user should include: None Not reviewed,
a. Patient’s goals (i.e., new recreation, vocation, or community requirements) Deleted
b. Functional assessment:
• Gait and mobility
• Residual limb health
• Contralateral limb
• Socket fit or residual limb volume
• Strength and range of motion (ROM)
• Changing needs for durable medical equipment (DME)
• Activities of daily living (ADL)
c. Secondary complications as a result of prosthetic use:
• Pain control
• Skin integrity
• Associated musculoskeletal conditions (e.g., back pain and knee pain).
d. Prosthetic assessment (repair, replacement, mechanical adjustment, new technology)
e. Vocational and recreational needs.
E 3 2 The follow-up assessment for a non-prosthetic user should include: None Not reviewed,
a. Patient’s goals Deleted
b. Functional assessment
• Residual limb health
• Range of motion (ROM)
• Strength
• Gait and mobility
• Changing needs for durable medical equipment (DME)
• Activities of daily living (ADL)
c. Secondary complications in the residual and contralateral limb:
• Pain control
• Skin integrity
• Associated musculoskeletal conditions (e.g., back and knee pain)
d. Vocational and recreational needs.

2007 Module 1
2007 Number
E 4 1 Long-term follow-up should include an assessment and management of risk factors for None Reviewed, New- Recommendation
secondary amputation including: peripheral vascular disease, diabetes, peripheral replaced 18
neuropathy or nerve injury, skin integrity, foreign bodies, bony deformities including
heterotopic ossification, and a history of foot ulcers.
E 4 2 For the patient with vascular disease or diabetes, long-term follow-up should include None Not reviewed,
appropriate foot care and patient education at every patient visit (see the VA/DoD Clinical Deleted
Practice Guideline for Diabetes Mellitus - Module F: Foot Care).
E 4 3 Patients identified to be at risk for limb-loss should be referred to an appropriate specialist. None Not reviewed,
Deleted
E 4 4 Encourage cardiovascular fitness to compensate for the increased metabolic cost of None Reviewed, New- Recommendation
ambulation post-amputation. replaced 14
E 4 5 Provide patient and family education regarding risk-modification to encourage a healthy None Reviewed, Recommendation
lifestyle through increased exercise, improved nutrition, and smoking cessation (see Amended 18
Appendix D: Foot Care Interventions for Patients with Amputation).
E 5 1 Intermittent/regular follow-up should be provided to assess the patient’s current needs, None Not reviewed,
abilities, and goals. Deleted
E 5 2 Life-long care should include monitoring the patient for psychosocial adjustment, skin None Reviewed, New- Recommendation
disorders of the residual limb, pain, musculoskeletal impairments, cardiovascular disease, replaced 18
other chronic diseases, and the health of the contralateral limb and provision of appropriate
foot wear for the contralateral foot.
E 5 3 A follow-up appointment should also be provided at the patient’s request, after a major None Not reviewed,
medical or functional change, or after a referral/consultation is received. Deleted
E 5 4 For the prosthetic user, life-long care should also include surveillance for and management None Reviewed, New- Recommendation
of secondary impairments associated with limb-loss; i.e., cardiovascular disease, accelerated replaced 18
degenerative joint disease of other joints, functional losses due to aging, and complications
of prosthetic use.
E 5 5 For the prosthetic user, new technology should be considered but must be matched to the None Reviewed, Deleted
patient’s function and goals, and followed with an additional period of gait training to help
the patient learn to use new components. The latest technology is not always the best
choice for the patient.

Appendix D: Participant List

Andrea Crunkhorn, DPT Louise Hassinger, CP
COL, U.S. Army (ret) Orthotic and Prosthetic Service
Clinical Affairs Program Coordinator Walter Reed National Military Medical Center
DoD & VA Extremity Trauma and Amputation Bethesda, MD
Center of Excellence
Falls Church, VA
M. Jason Highsmith, PT, DPT, PhD, CP, FAAOP Lisa D. Jones, RN, BSN, MHA, CPHQ
Deputy Chief- Research & Surveillance Division Population Health Nurse Consultant
Extremity Trauma and Amputation Center of U.S. Army Medical Command
Excellence Office of Evidence-Based Practice
VA Medical Center San Antonio, TX
Tampa, FL
John P. McCallin, MD, FAAPMR Martin L. McDowell, L/CPO, FAAOP
MAJ, U.S. Army Program Manager, Orthotic and Prosthetic Clinical
Chief, Physical Medicine & Rehabilitation Service Services
Department of Pain Rehabilitation and Prosthetics Service
San Antonio, TX VA Health Administration
Washington, DC
Kelly McGaughey PT, DPT Joseph A. Miller, PhD, MS, CP
Center Coordinator of Clinical Education Senior Advisor Technologist Clinical Prosthetics
Amputee Physical Therapy Service Extremity Trauma and Amputation Center of
Walter Reed National Military Medical Center Excellence Washington, DC
Bethesda, MD
Lynita Mullins, DO, LCDR, MC, USN Keith P. Myers, MD
Physical Medicine & Rehabilitation/ Comprehensive LTC, U.S. Army
Combat & Complex Casualty Care Assistant Head, Department of Rehabilitation
Medical Director, C5 Traumatic Brain Injury Walter Reed National Military Medical Center
Site Director, Defense and Veterans Brain Injury Bethesda, MD
Center
San Diego, CA
Leif Nelson, DPT, ATP, CSCS Annemarie Orr, OTD, OTR/L
Assistant Chief for Clinical Care Occupational Therapist Amputee Service
Extremity Trauma and Amputation Center of Military Advanced Training Center
Excellence Walter Reed National Military Medical Center
VA NY Harbor Healthcare System Bethesda, MD
U.S. Department of Veterans Affairs
New York, NY
Paul F. Pasquina, MD Benjamin Kyle Potter, MD, FACS
COL, U.S. Army (ret) LTC, U.S. Army
Chief, Department of Rehabilitation Chief Orthopaedic Surgeon, Amputee Patient Care
Walter Reed National Military Medical Center Musculoskeletal Oncology
Bethesda, MD Walter Reed National Military Medical Center
Bethesda, MD

Andrea Crunkhorn, DPT Louise Hassinger, CP

COL, U.S. Army (ret) Orthotic and Prosthetic Service
Clinical Affairs Program Coordinator Walter Reed National Military Medical Center
DoD & VA Extremity Trauma and Amputation Bethesda, MD
Center of Excellence
Falls Church, VA
Alison L. Pruziner, PT, DPT, ATC Billie Jane Randolph, PT, PhD
Research Physical Therapist COL, U.S. Army (ret)
Extremity Trauma and Amputation Center of Deputy Director, Extremity Trauma and Amputation
Excellence Center of Excellence
Walter Reed National Military Medical Center Veterans Health Administration
Bethesda, MD Washington, DC
Aaron Turner, PhD, ABPP (RP) Deborah Velez, RN, MN, GNP-BC
Director, Rehabilitation Psychology Nurse Practitioner
Puget Sound Healthcare System VA San Diego Healthcare System
Seattle, WA San Diego, CA
Joseph Webster, MD Patty Young, MSPT, CP
Medical Director, Servicemember Transitional Amputee Rehabilitation Coordinator
Advanced Rehabilitation Program Hunter Holmes McGuire VA Medical Center
Hunter Holmes McGuire VA Medical Center Richmond, VA
Richmond, VA

Appendix E: Patient Focus Group Methods and Findings

A. Methods
On May 24, 2016, as part of the effort to update this CPG, the VA and DoD Leadership, along with the LLA
CPG Work Group, held a patient focus group at Walter Reed Medical Center in Bethesda, Maryland. Focus
group participants included seven patients, including two females.
The aim of the focus group was to further the understanding of the perspectives of patients undergoing
rehabilitation of LLA within the VA and/or DoD healthcare systems, as these patients are most affected by
the recommendations put forth in the updated LLA CPG. The focus group explored patient perspectives on
a set of topics related to rehabilitation of LLA in the VA and DoD healthcare systems, including knowledge
of LLA rehabilitation options, views on delivery of care, and the impact of LLA and the challenges it poses.
Participants for the focus group were recruited by the LLA CPG Champions and Work Group members.
Patient focus group participants were not intended to be a representative sample of VA and DoD patients
who have experienced LLA. However, recruitment focused on eliciting a range of perspectives likely to be
relevant and informative in the guideline development process. Patients were not incentivized for their
participation or reimbursed for travel expenses.
The LLA CPG Champions and Work Group, with support from Lewin, developed a set of questions to help
guide the focus group. The facilitator from Lewin, Clifford Goodman, PhD, led the discussion using
questions prepared by the Work Group as a general guide to elicit the most important information from
the patients regarding their experiences and views about their rehabilitation and overall care. Given the
limited time and the range of interests of the participants, not all of the listed questions were addressed.
At the time of the focus group, three participants received care in the DoD healthcare system and four had
experienced care through the VA system. Several individuals had also received private care at certain
points, either immediately after their injuries when they received acute care at a private hospital, or later
in rehabilitation when they used personal insurance to receive private care. However, at the time of the
focus group, all of the participants were receiving care at Walter Reed Army Medical Center, and those
who had transitioned to care under the VA had opted to return to Walter Reed for their continued care.
The following concepts are aspects of care that patients indicated were important during the course of
the focus group discussion. Each of these themes was an important and needed aspect of participants’
healthcare.
B. Patient Focus Group Findings

a. Recognize the importance of a transdisciplinary care team and the necessity for
patients to have a trusting relationship with their prosthetist.
• Patients consider the most important care team relationship is with their prosthetist. Due to the
sensitive nature of frequent physical interactions and the quality of life factors that depend on a
good prosthetic fit, it is of utmost importance to have a prosthetist that will understand the
patient’s goals, preferences, and rehabilitation challenges.

• After the acute treatment phase has ended, patients typically see their primary care physicians
rarely and only when necessary for such matters as prescription refills or rehabilitation referrals.
• Patients also value having a behavioral/psychological health professional as part of the
transdisciplinary care team.
b. Consider patient-specific goals, values, and preferences and use shared decision
making to develop a rehabilitation plan.
• Identify patient-specific goals associated with LLA rehabilitation, including, e.g., medication
management, adapting to activities patients valued prior to their amputation, and addressing
personalized “real world” obstacles in physical and occupational therapy settings.
• Use shared decision making to develop an individualized rehabilitation plan; discuss pros and
cons of each option in conjunction with each patient’s goals (e.g., level of function and mobility),
priorities, values, and preferences.
• Maintain focus on patient goals and keep in close communication with members of the patient’s
care team throughout the rehabilitation process.
c. Address strategies for medication management across all phases of the

rehabilitation process.
• After the acute stage of recovery from surgery when patients may be on strong medications,
consider when and how to wean them from certain of those medications to reduce side effects
and to reduce the risk of developing dependence.
• Discuss pharmacologic options in depth with the patient, including possible side effects (e.g.,
depression, anxiety, sleep loss, weight gain) that may significantly affect a patient’s
rehabilitation; seek to understand a patient’s preference for reducing or eliminating certain
medicines from their treatment plan.
• Be prepared to adjust or otherwise change treatment (e.g., tapering pain medication) subject to
patient response, preferences, and changes in priorities and goals.
d. Involve caregivers and leverage peer networks to create support and

motivation for patients with lower limb amputations.
• Facilitate peer visitation soon after a patient’s amputation surgery to build a network of
support. When appropriate, consider the nature of the patient’s injury and their demographic
characteristics in order to pair the patient with a peer who experienced similar challenges.
• Include family members early in rehabilitation discussions, especially regarding what to expect
during each stage of rehabilitation.
• Build and maintain trust, respect, and support with the patient and their family.
e. Consider unique challenges faced by different patient populations (e.g.,
females) during rehabilitation.
• Recognize which patients may face particular or unusual types of challenges during their
rehabilitation (e.g., female patients).

• Work with patients and their rehabilitation teams to provide personalized care and solutions to
their particular challenges.
f. Work with providers to ensure continuity of care and ease of access to preferred
providers and prescriptions.
• When planning rehabilitation, consider proximity of care sites and try to minimize travel and
time requirements as appropriate.
• Work with providers to ensure continuity of care and ease of access to preferred providers.
• Understand the education and rehabilitation a patient may have received before transferring to
a different health center.

Appendix F: Literature Review Search Terms and Strategy

A. Topic-specific Search Terms
The search strategies employed combinations of free-text keywords as well as controlled vocabulary
terms including (but not limited to) the following concepts. Strategies for each bibliographic database
follow this table.
Table E-1. EMTREE, Medical Subject Headings (MeSH), PsycInfo, and Keywords
Concept Controlled Vocabulary Keywords
Amputation/amputation EMBASE (EMTREE) amputee
stumps above knee amputation bilateral
amputation amputation
amputation stump disarticulation
ankle amputation limb loss
below knee amputation partial foot
foot amputation amputation
knee amputation transfemoral
leg amputation transtibial
limb amputation unilateral
lower extremity amputation
thigh amputation
through knee amputation
transfemoral amputation
transtibial amputation
traumatic amputation
Medline (MeSH)
amputation
amputation stumps
amputation, traumatic
amputees
disarticulation
PsycINFO
amputation


Lower Extremity Sites EMBASE (EMTREE) through knee
above knee prosthesis
below knee prosthesis
foot
foot disease
foot injury
foot surgery
hallux
hip
knee
knee injury
knee prosthesis
leg
leg injury
leg prosthesis
lower leg prosthesis
toe
toe injury
toe phalanx
Medline (MeSH)
arthroplasty, replacement, toe
artificial limbs
foot
foot bones
foot injuries
foot joints
hallux
knee
knee injuries
knee prosthesis
leg
leg bones
leg injuries
toe injuries
toe joint
toe phalanges
toes


Artificial Limbs/ EMBASE (EMTREE) air limb
Prosthetics above knee prosthesis c leg
ankle prosthesis computer assisted
below knee prosthesis elevated vacuum
electric limb prosthesis implants
foot prosthesis intelligent prosthesis
hip disarticulation prosthesis interface
leg prosthesis irc
limb prosthesis ischial containment
lower leg prosthesis ischial ramus containment
prosthesis knee unit
prosthesis fixation microprocessor
prosthetic fitting patella tendon bearing
Medline (MeSH) pin suspension
artificial limbs prostheses
PsycINFO prosthesis design
prostheses prosthesis implantation
prosthetic socket
robotics
signal processing
socket
suspension system
total surface bearing
user-computer interface
vacuum assisted suspension


Pre- and Post-Operative EMBASE (EMTREE) contracture prevention
Rehabilitation exercise contralateral limb
exercise movement techniques core stability
exercise therapy core strength
gait training edema control
kinesiotherapy equipment order*
mental health care fall prevention
occupational therapy flexibility training
patient education hip strength
peer support home exercise
physical activity manual training
physical education and training mental health screen*
physical exercise mobility training
physical exertion overground
physical therapy pain management
physical therapy modalities post operative intervention*
physiotherapy post operative rehabilitation
range of motion pre operative intervention*
rehabilitation pre operative rehabilitation
rehabilitation care removable dressing
rehabilitation centers rigid dressing
rehabilitation medicine skin care
rehabilitation nursing soft dressing
rehabilitation patient strengthening
resistance training treadmill training
self care
weight bearing
Medline (MeSH)
activities of daily living
exercise therapy
occupational therapy
physical exertion
physical therapy modalities
rehabilitation
rehabilitation centers
rehabilitation nursing
rehabilitation, vocational


Pain Management EMBASE (EMTREE) phantom limb pain
intractable pain residual limb pain
limb pain
pain
phantom pain
postoperative pain
Medline (MeSH)
pain
pain, postoperative
phantom limb
PsycINFO
chronic pain
neuropathic pain
pain
pain perception
Surgical Interventions EMBASE (EMTREE) amputation methods
limb salvage bone bridging
salvage therapy burgess
surgical technique disarticulation
Medline(MeSH) Ertl
salvage therapy hemipelvectomy
lower extremity surgery
myodesis
osseointegration
Tests to predict EMBASE (EMTREE) 6 min walk distance
outcomes from psychometrics 6 minute walking test
amputation surgery Medline (MeSH) amputee mobility predict*
psychometrics cut point
minimal change
normative value*
six minute walking distance
six minute walking distance test
six minute walking test
step activity monitor*
threshold value
timed up and go
timed up and go test
TUG


Demographics EMBASE (EMTREE) gender
age gender differences
demography woman
educational status women
employment status
female
gender
male
marriage
race
social class
transgender
Medline (MeSH)
age groups
demography
employment
female
gender identity
male
marriage
social class
transgender persons
Comorbidities EMBASE (EMTREE) amputation level
brain injury amputation location
cognitive defect amputation site
comorbidity k-level*
comorbidity assessment PTSD
diabetes mellitus traumatic amputation
neoplasm vascular amputation
neurologic disease
posttraumatic stress disorder
Medline (MeSH)
brain injuries
cognition disorders
comorbidity
diabetes mellitus
neoplasms
stress disorders, post-traumatic


Outcomes EMBASE (EMTREE) outcomes
daily life activity
employment
functional independence measure
functional status
functional status assessment
gait
mobility assessment
outcome
outcome assessment
patient satisfaction
postoperative complication
prognosis
quality of life
treatment outcome
walking
Medline (MeSH)
activities of daily living
cost of illness
employment
health expenditures
health status
independent living
outcome assessment (health care)
patient acceptance of health care
patient satisfaction
postoperative complications
prognosis
quality of life
recovery of function
self concept
social adjustment
social participation
treatment outcome
B. Search Strategies
Table E-2. MEDLINE (presented in OVID syntax)
Set
Number Concept Search Statement
1 Amputation 'through knee amputation'/exp OR 'thigh amputation' OR 'bilateral amputation*' OR
'limb loss' OR 'lower extremity amputation'/exp OR 'leg amputation'/exp OR 'ankle
amputation'/exp OR 'foot amputation'/exp OR 'amputation'/exp OR 'amputation
stump'/exp OR 'above knee amputation'/exp OR 'below knee amputation'/exp OR
'knee amputation'/exp OR 'limb amputation'/exp OR 'traumatic amputation'/exp OR
((ankle* OR feet OR foot OR 'partial foot' OR hallux OR hip* OR knee* OR leg OR legs
OR 'lower extremity' OR 'lower limb' OR 'through knee' OR thigh OR bilateral OR toe
OR toes OR transfemoral OR transtibial) NEAR/3 (amputat* OR disarticulat*)):ab,ti

Set
2 Lower Limb 'thigh'/exp OR 'leg'/exp OR 'leg injury'/exp OR 'knee'/exp OR 'knee injury'/exp OR
'toe'/exp OR 'hallux'/exp OR 'toe phalanx'/exp OR 'toe phalanges'/exp OR 'toe
injury'/exp OR 'foot'/exp OR 'foot injury'/exp OR 'foot disease'/exp OR 'foot
surgery'/exp OR 'hip'/exp OR ((ankle* OR feet OR foot OR hallux OR hip* OR knee* OR
leg OR legs OR 'lower extremity' OR 'lower limb' OR thigh OR toe OR toes OR
transfemoral OR transtibial) NEAR/2 (diseas* OR injur*)):ab,ti
3 Prosthetic 'foot prosthesis'/exp OR 'ankle prosthesis'/exp OR 'above knee prosthesis'/exp OR
'below knee prosthesis'/exp OR 'electric limb prosthesis'/exp OR 'hip disarticulation
prosthesis'/exp OR 'leg prosthesis'/exp OR 'lower leg prosthesis'/exp OR 'limb
prosthesis'/exp OR 'prosthesis fixation'/exp OR 'prosthesis'/exp OR 'socket' OR
'interface' OR 'suspension system' OR 'knee units' OR 'knee unit' OR 'prosthetic
socket' OR 'prosthetic fitting'/exp OR 'vacuum assisted suspension' OR 'air limb' OR
'total surface bearing' OR 'patella tendon bearing prosthesis' OR 'pin suspension' OR 'c
leg'/exp OR 'intelligent prostheses' OR ((ankle* OR feet OR foot OR hallux OR hip* OR
knee* OR leg OR legs OR 'lower extremity' OR 'lower limb' OR toe OR toes OR
transfemoral OR transtibial) NEAR/3 (artificial* OR microprocessor* OR prosthes* OR
prosthet*)):ab,ti
4 Socket/Interface (stump OR 'below knee' OR 'above knee' OR 'through knee' OR hsd OR 'patella tendon
bearing' OR 'patellar tendon bearing' OR ptb OR 'total surface bearing' OR tsb OR
'ischial containment' OR 'ischial ramus containment' OR ic OR irc OR 'knee
disarticulation' OR 'hip disarticulation' OR vass OR 'total contact') NEAR/2 (socket* OR
interface*)
5 Suspension 'elevated vacuum' OR 'vacuum assisted suspension' OR 'anatomic fit' OR
'osseointegration'/exp OR 'suspension sleeve' OR 'supracondylar' OR 'corset
suspension'/exp OR 'pin suspension' OR 'locking mechanism' OR 'lanyard' OR 'thigh
cuff' OR belt NEAR/2 suspension
6 Knees (microprocessor OR 'non microprocessor' OR hydromechanical OR polycentric OR
'single axis' OR 'mauch sns' OR 'swing and stance' OR 'weight activated stance
breaking' OR wasb OR 'manual locking' OR 'c leg' OR 'c-leg' OR power OR
hydracadence OR rheo) NEAR/2 (knee OR knees)
7 Feet 'energy storing and release' OR es OR esr OR esar OR 'energy storing' OR 'dynamic
response' OR sach OR 'solid ankle cushioned heel' OR 'flexible keel' OR 'flex foot' OR
'proprio foot' OR 'biom foot' OR 'single axis foot' OR 'multi axial foot' OR 'running foot'
OR cheetah NEAR/2 (foot OR feet) AND (foot OR feet)
8 Combine Sets 1 OR 2
9 Combine Sets 3 OR 4 OR 5 OR 6 OR 7
10 Combine Sets 8 AND 9
11 Exclude 10 NOT (abstract:nc OR annual:nc OR book/de OR 'case report'/de OR 'case study'/de
Unwanted OR conference:nc OR 'conference abstract':it OR 'conference paper'/de OR
Publications 'conference paper':it OR 'conference proceeding':pt OR 'conference review':it OR
congress:nc OR editorial/de OR editorial:it OR erratum/de OR letter:it OR note/de OR
note:it OR meeting:nc OR sessions:nc OR 'short survey'/de OR symposium:nc)
12 Limit to Humans Limit 11 to humans
13 Limit to English Limit 12 to English language
Language

Set
14 Limit by 13 AND [2007-2016]/py
Publication Date
OVID syntax:
$ or * = truncation character (wildcard)
ADJn = search terms within a specified number (n) of words from each other in any order
/ = search as a subject heading (note that terms preceded by an asterisk are searched as a major
subject headings)
exp = “explodes” controlled vocabulary term (e.g., expands search to all more specific related terms
in the vocabulary’s hierarchy)
.de. = limit controlled vocabulary heading
.fs. = floating subheading
.hw. = limit to heading word
.md. = type of methodology (PsycINFO)
.mp. = combined search fields (default if no fields are specified)
.pt. = publication type
.ti. = limit to title
.tw. = limit to title and abstract fields

Table E-3. EMBASE

Set
1 Lower Limb Amputation 'through knee amputation'/mj OR 'thigh amputation':ab,ti OR 'bilateral
amputation*':ab,ti OR 'limb loss':ab,ti OR 'lower extremity amputation'/mj OR
'leg amputation'/mj OR 'ankle amputation'/mj OR 'foot amputation'/mj OR
'amputation'/mj OR 'amputation stump'/mj OR 'above knee amputation'/mj
OR 'below knee amputation'/mj OR 'knee amputation'/mj OR 'limb
amputation'/mj OR 'traumatic amputation'/mj OR ((ankle* OR feet OR foot
OR 'partial foot' OR hip* OR knee* OR leg OR legs OR 'lower extremity' OR
'lower limb' OR 'through knee' OR thigh OR bilateral OR toe OR toes OR
transfemoral OR transtibial) NEAR/3 (amputat* OR disarticulat*)):ab,ti
2 Gait and Mobility 'gait training'/mj OR 'mobility training':ab,ti OR ((treadmill OR overground OR
Training manual) NEAR/2 (training OR gait OR mobility)):ab,ti
3 Surgical Interventions 'surgical technique'/mj OR 'bone bridg*':ab,ti OR 'bone-bridg*':ab,ti OR (bone
NEAR/2 bridg*):ab,ti OR 'myodesis':ab,ti OR 'osseointegration'/mj OR
'amputation methods':ab,ti OR (amputation NEAR/2 method*):ab,ti OR
'ertl':ab,ti OR 'lower extremity surgery':ab,ti OR 'hemipelvectomy':ab,ti OR
'disarticulation':ab,ti OR 'burgess':ab,ti
4 Tests to Predict '6 minute walking test' OR 'six minute walking distance' OR 'six minute walking
Outcomes distance test' OR 'six minute walking test' OR '6 minute walking distance' OR
'6 min walk test' OR '6 min walk distance' OR 'step activity monitor*':ab,ti OR
('amputee mobility' NEAR/2 predict*):ab,ti OR 'cut point*':ab,ti OR 'timed up
and go' OR 'timed up and go test' OR 'tug':ab,ti OR 'threshold value*':ab,ti OR
'normative value*':ab,ti OR 'minimal change':ab,ti OR 'psychometrics'/mj
5 Gender Designation 'gender differences':ab,ti OR 'female'/mj OR 'male'/mj OR 'transgender'/mj
OR gender:ti OR transgender:ti OR female:ti OR women:ti OR woman:ti
6 Demographics, 'above knee amputation'/exp OR age/exp OR (amput* NEXT/1 (level* OR
Comorbidities, location* OR site*)):ab,ti OR 'below knee amputation'/exp OR 'brain
Amputation injury'/exp OR 'cognitive defect'/exp OR comorbidity/exp OR 'comorbidity
Characteristics assessment'/exp OR demography/exp OR 'diabetes mellitus'/exp OR
neoplasm/exp OR 'educational status'/exp OR 'employment status'/exp OR
gender/exp OR (‘k-level’ OR 'k-levels'):ab,ti OR marriage/exp OR 'neurologic
disease'/exp OR 'posttraumatic stress disorder'/exp OR race/exp OR 'social
class'/exp OR ((traumatic* OR vascular) NEXT/1 amput*):ab,ti
7 Outcomes 'daily life activity'/exp OR 'functional independence measure'/exp OR
'functional status'/exp OR 'functional status assessment’/exp OR gait/exp OR
'mobility assessment'/exp OR outcome*:ab,ti 'outcome assessment'/exp OR
'patient satisfaction'/exp OR 'quality of life'/exp OR 'treatment outcome'/exp
OR walking/exp

Set
8 Rehabilitation 'activities of daily living'/exp OR 'home exercise' OR 'phantom limb pain'/exp
OR 'residual limb pain' OR 'range of motion'/exp OR ((preoperative OR 'pre
operative') NEXT/2 rehabilitat*):ab,ti OR 'patient education'/exp OR (core
NEXT/2 strength):ab,ti OR 'core stability' OR (hip NEXT/2 strength):ab,ti OR
(equipment NEXT/2 order*):ab,ti OR ((postoperative OR 'post operative')
NEXT/2 intervention*):ab,ti OR (soft NEXT/2 dressing*):ab,ti OR (rigid NEXT/2
dressing*):ab,ti OR 'weight bearing'/exp OR 'resistance training'/exp OR
(removable NEXT/2 dressing*):ab,ti OR ('mental health' NEXT/2 screen*):ab,ti
OR 'mental health care'/exp OR strengthening:ab,ti OR (flexibility NEXT/2
training):ab,ti OR 'peer support'/exp OR (contralateral NEXT/1 limb):ab,ti OR
(skin NEXT/1 care):ab,ti OR (pain NEXT/1 management):ab,ti OR (edema
NEXT/2 control*):ab,ti OR (fall NEXT/2 prevention):ab,ti OR (contracture
NEXT/2 prevention):ab,ti OR 'physical education and training'/exp OR
'exercise'/exp OR 'kinesiotherapy'/exp OR 'physical activity'/exp OR 'exercise
movement techniques'/exp OR 'exercise therapy'/exp OR 'self care'/exp OR
'physical therapy'/exp OR 'physiotherapy'/exp OR 'occupational therapy'/exp
OR 'rehabilitation'/exp OR 'physical exertion'/exp OR 'physical exercise'/exp
OR 'physical therapy modalities'/exp OR 'rehabilitation centers'/exp OR
'rehabilitation nursing'/exp OR 'rehabilitation patient'/exp
9 Combine Sets 1 AND (2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8)
10 Exclude Unwanted 9 NOT (abstract:nc OR annual:nc OR 'book'/de OR 'case report'/de OR 'case
Publications study'/de OR conference:nc OR 'conference abstract':it OR 'conference
paper'/de OR 'conference paper':it OR 'conference proceeding':pt OR
'conference review':it OR congress:nc OR 'editorial'/de OR editorial:it OR
'erratum'/de OR letter:it OR 'note'/de OR note:it OR meeting:nc OR
sessions:nc OR 'short survey'/de OR symposium:nc)
11 Limit to Humans Limit 10 to humans
12 Limit to English Limit 11 to English

13 Limit by Publication Date 12 AND [2007-2016]/py
EMBASE.com Syntax:
* = truncation character (wildcard)
NEAR/n = search terms within a specified number (n) of words from each other in any order
NEXT/n = search terms within a specified number (n) of words from each other in the order specified
/ = search as a subject heading
exp = “explodes” controlled vocabulary term (e.g., expands search to all more specific related
terms in the vocabulary’s hierarchy)
mj = denotes a term that has been searched as a major subject heading
:de = search in the descriptors field (controlled terms and keywords)
:lnk = floating subheading
:it,pt. = source item or publication type
:ti. = limit to title
:ti,ab. = limit to title and abstract fields

Appendix G: Abbreviation List

Abbreviation Definition
2MWT two minute walk test
4SST four square step test
6MWT six minute walk test
10mwt ten meter walk test
ABC Activities-specific Balance Confidence Scale
ADL activities of daily living
AHRQ Agency for Healthcare Research and Quality
AMP Amputee Mobility Predictor
AMPnoPRO Amputee Mobility Predictor – no Prosthesis
AMPPRO Amputee Mobility Predictor – with Prosthesis
AT assistive technology
CARF Commission on the Accreditation of Rehabilitation Facilities
CDC Centers for Disease Control and Prevention
CHAMP Comprehensive High-level Activity Mobility Predictor
COI conflict of interest
CPG clinical practice guideline
CS comparative study
DoD Department of Defense
DME durable medical equipment
EBPWG Evidence-Based Practice Work Group
FY fiscal year
GRADE Grading of Recommendations Assessment, Development and Evaluation
HAI Hill Assessment Index
ICF International Classification of Functioning, Disability, and Health
IQR interquartile range
IRF inpatient rehabilitation facility
JC Joint Commission
K(0-4) Medicare functional levels
KQ key question
LCI Locomotor Capabilities Index
LLA lower limb amputation
m meter(s)
md median
MeSH Medical Subject Headings
MFCL Medicare functional classification level
min minutes
mn mean
NICE National Institute for Health and Care Excellence
OPUS Orthotic Prosthetic User Survey
PCC patient-centered care
PEQ-MS Prosthesis Evaluation Questionnaire-Mobility Subscale
PICOTS population, intervention, comparison, outcome, timing and setting
PLP phantom limb pain

Abbreviation Definition
PLS phantom limb sensation
PTSD posttraumatic stress disorder
PVD peripheral vascular disease
RCT randomized controlled trial
Rng range
RRD rigid removable dressing
SACH solid ankle cushioned heel
SAI stair assessment index
SDM shared decision making
sec second(s)
SNF skilled nursing facility
SR systematic review
SRRD semi-rigid removable dressing
TACT transdisciplinary amputation care team
TAPES Trinity Amputation and Prosthesis Experience Scales
TFA transfemoral amputation
TTA transtibial amputation
TUG timed up and go
US United States
USPSTF United States Preventive Services Task Force
VA Department of Veterans Affairs
WA walk aid
yo years old

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VA/DoD CLINICAL PRACTICE GUIDELINE FOR

REHABILITATION OF INDIVIDUALS WITH

Department of Veterans Affairs

Version 2.0 – 2017

The Rehabilitation of Individuals with Lower Limb Amputation

With support from:

The Office of Quality, Safety and Value, VA, Washington, DC

Version 2.0 – 2017

Based on evidence reviewed through July 2016

September 2017 Page 2 of 123

II. Recommendations ........................................................................................................................... 6

IV. About this Clinical Practice Guideline ............................................................................................. 11

V. Guideline Work Group ................................................................................................................... 20

VI. Algorithm ...................................................................................................................................... 21

VII. Discussion of Recommendations .................................................................................................... 24

VIII. Knowledge Gaps and Recommended Research .............................................................................. 46

September 2017 Page 3 of 123

F. Prosthetic interventions .................................................................................................................... 47

Appendix A: Evidence Review Methodology....................................................................................... 48

Appendix B: Evidence Table ............................................................................................................... 64

Appendix C: 2007 Recommendation Categorization Table.................................................................. 68

Appendix D: Participant List................................................................................................................ 99

Appendix E: Patient Focus Group Methods and Findings .................................................................. 101

Appendix F: Literature Review Search Terms and Strategy ............................................................... 104

Appendix G: Abbreviation List........................................................................................................... 115

References .......................................................................................................................................... 117

September 2017 Page 4 of 123

September 2017 Page 5 of 123

September 2017 Page 6 of 123

# Recommendation Strength* Category†

September 2017 Page 7 of 123

c. Other Causes of Amputation

September 2017 Page 8 of 123

d. Limb Salvage and Delayed Amputation

B. Epidemiology and Impact

e. Epidemiology of Non-Traumatic Amputation

f. Epidemiology of Traumatic Amputation

September 2017 Page 9 of 123

C. Lower Limb Amputation in the Department of Veterans Affairs and the

D. Factors Affecting Rehabilitation of Lower Limb Amputation

September 2017 Page 10 of 123

IV. About this Clinical Practice Guideline

September 2017 Page 11 of 123

Appendix A provides a detailed description of each of these tasks.

September 2017 Page 12 of 123

• Patient or provider values and preferences

b. Reconciling 2007 Clinical Practice Guideline Recommendations

September 2017 Page 13 of 123

c. Peer Review Process

September 2017 Page 14 of 123

B. Summary of Patient Focus Group Methods and Findings

September 2017 Page 15 of 123

LLA CPG Patient Focus Group Concepts

D. Scope of this Clinical Practice Guideline

September 2017 Page 16 of 123

E. Highlighted Features of this Clinical Practice Guideline

September 2017 Page 17 of 123

G. Shared Decision Making