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Consensus statement

Selection criteria for patients with chronic ankle

instability in controlled research: a position
Editor’s choice
statement of the International Ankle Consortium
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Phillip A Gribble,1 Eamonn Delahunt,2 Chris Bleakley,3 Brian Caulfield,4

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Carrie Docherty,5 François Fourchet,6 Daniel Tik-Pui Fong,7 Jay Hertel,8 Claire Hiller,9
Thomas Kaminski,10 Patrick McKeon,11 Kathryn Refshauge,9 Philip van der Wees,12
1
University of Toledo, Toledo, Bill Vincenzino,13 Erik Wikstrom14
Ohio, USA
2
School of Public Health,
Physiotherapy and Population ABSTRACT approximately 8% of the general population who
Science, University College While research on chronic ankle instability (CAI) and report persistent symptoms following an initial ankle
Dublin, Dublin, Ireland
3
Univerisity of Ulster, awareness of its impact on society and health care sprain.10 Chronic joint injury and degeneration is
Jordanstown, Carrickfergus, UK systems has grown substantially in the last 2 decades, associated with over US$3 billion in annual health-
4
School of Physiotherapy, the inconsistency in participant/patient selection criteria care costs in the USA.11 Evidence for the relationship
University College Dublin, across studies presents a potential obstacle to addressing between acute and recurrent ankle joint trauma and
Dublin, UK
5 the problem properly. This major gap within the the development of post-traumatic ankle joint osteo-
University of Indiana,
Bloomington, Indiana, USA literature limits the ability to generalise this evidence to arthritis (OA) is growing.11 12 Saltzman et al13 have
6
Qatar Orthopaedic and Sports the target patient population. Therefore, there is a need reported that as many as four in five cases of ankle
Medicine Hospital, Doha, Qatar
7
to provide standards for patient/participant selection joint OA are the result of previous musculoskeletal
Department of Orthopaedics criteria in research focused on CAI with justifications trauma, with these patients being on average a
and Traumatology, The Chinese
University of Hong Kong, Hong
using the best available evidence. The International decade younger than patients with primary ankle
Kong, China Ankle Consortium provides this position paper to present joint OA. Additionally, self-reported disability using
8
Kinesiology Program, and discuss an endorsed set of selection criteria for the SF-36 physical component score was significantly
University of Virginia, patients with CAI based on the best available evidence lower in patients with ankle OA from the USA13 as
Charlottesville, Virginia, USA to be used in future research and study designs. These compared with the general population, and was also
9
Department of Physiotherapy,
University of Sydney, Sydney, recommendations will enhance the validity of research equal to or lower compared with patients with end-
New South Wales, Australia conducted in this clinical population with the end goal stage kidney disease,14 chronic heart failure15 or
10
Department of Health, of bringing the research evidence to the clinician and Parkinson’s disease.16 Therefore, ankle joint sprains
Nutrition and Exercise patient. and its associated sequelae affect individuals across
Sciences, University of
Delaware, Newark, New Jersey,
the lifespan and represent a large healthcare burden.
USA
11
Department of Rehabilitation EPIDEMIOLOGY AND IMPACT OF ANKLE Advances in research
Sciences, University of INJURY The prevalence and impact of ankle sprains on
Kentucky, Lexington, Kentucky,
USA
Injuries to the ankle joint account for 20% of the society and healthcare systems support the need for
12
Radboud University Nijmegen population that is afflicted with joint injury.1 There continued research related to the prevention, treat-
Medical Centre, Nijmegen are more than three million emergency room visits ment and rehabilitation of ankle sprains and their
Area, Netherlands
13
annually for ankle/foot injuries in the USA,2 and associated sequelae. As aforementioned, an unfor-
Department of Physiotherapy, the largest percentage of self-reported musculoskel-
University of Queensland,
tunate and prominent consequence of acute ankle
Brisbane, Queensland, etal injuries (> 10%) are to the ankle.3 More than sprains is a very high recurrence rate. It has been
Australia 628 000 ankle injuries, including ankle sprains and reported that 32–74% of individuals with a history
14
University of North Carolina, fractures, per year are treated in USA emergency of ankle sprain have some type of residual and
Charlotte, North Carolina, USA rooms, accounting for 20% of all injuries treated in chronic symptoms, recurrent ankle sprains and/or
Correspondence to
emergency facilities.4 Ankle sprains account for an perceived instability.17 18 Evidence from peer-
Dr Phillip Gribble, University of estimated 3–5% of emergency room visits in the reviewed literature suggests that the characteristics
Toledo, Mailstop #119 2801 UK,5 representing a significant amount of devoted of patients with recurrent ankle injury are not
W. Bancroft, Toledo, healthcare resources. Additionally, it is estimated homogeneous. Many categorical descriptions have
OH 43606, USA; that as many as 55% of patients who sustain an
phillip.gribble@utoledo.edu
been used to define this pathology, including
ankle sprain do not seek evaluation or treatment chronic ankle instability (CAI), functional ankle
Accepted 10 October 2013 from a healthcare professional.6 Subsequently, the instability, mechanical ankle instability (MAI) and
Published Online First reporting of traumatic ankle sprains may be grossly recurrent ankle instability.19–21 CAI has been
19 November 2013 under-reported in healthcare statistics. defined in a variety of ways, but is most predomin-
antly described ‘as an encompassing term used to
SHORT-TERM AND LONG-TERM SEQUELAE classify a subject with both mechanical and func-
Traumatic ankle injury represents a significant health- tional instability of the ankle joint.’20
care issue. Of further significance is that ankle sprains
To cite: Gribble PA, have a high rate of recurrence (as high as 80% in International Ankle Consortium position
Delahunt E, Bleakley C, high-risk sports).7–9 Recent data indicate that ankle statement
et al. Br J Sports Med sprains are not just an innocuous injury primarily The International Ankle Consortium is an inter-
2014;48:1014–1018. incurred by young athletes; rather, they also impact national community of researchers and clinicians

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Consensus statement

whose primary scholastic purpose is to promote scholarship and which are dependent on the complex interaction of mechanical
dissemination of research informed knowledge related to path- insufficiencies, perceived instability and frequency of recurrent
ologies of the ankle complex. The constituents of the sprains.
International Ankle Consortium and other similar organisations
have yet to properly define the clinical phenomenon known as Rationale
CAI and its related characteristics for consistent patient recruit- When one examines the body of work related to repeated and
ment and advancement of research in this area. While research recurrent ankle joint injury and instability, there is a spectrum of
on CAI and awareness of its impact on society and healthcare patient characteristics that have been used within the ankle
systems have grown substantially in the last two decades, the instability (including CAI and functional ankle instability)
inconsistency in participant/patient selection criteria across research literature from the past two decades.20 21 Delahunt
studies presents a potential obstacle to addressing the problem et al20 systematically investigated these issues in the research
properly. This major gap within the literature limits the ability relating to recurrent ankle joint sprain and the resulting incon-
to generalise this evidence to the target patient population. sistent definitions and use of terms such as CAI, functional
Therefore, there is a need to provide standards for patient/par- ankle instability, etc. They concluded that CAI was the most
ticipant selection criteria in research focused on CAI with justifi- commonly used term to describe individuals who report
cations using the best available evidence. The primary rationale ongoing symptoms after an initial ankle sprain; and the most
for documenting such standards is to outline specific inclusion commonly reported deficits associated with CAI were frequent/
criteria that should be reported on as a minimum when con- recurrent sprains and episodes of or the reporting of feelings of
ducting research in the area of CAI. This will be of particular ankle joint ‘giving way’. Subsequently, the authors advocated
importance as research into CAI continues to grow and become that research in this area could be improved if consistent termin-
more sophisticated, especially to enable high-fidelity synthesis ology and a specific set of patient selection criteria could be
and meta-analyses of data through future systematic reviews. established.
Although CAI is a multifaceted condition, there have been
research developments to capture functional deficits associated Statement objectives
with those who have recurrent issues. Freeman et al22 were It is the opinion of the International Ankle Consortium that
among the first to recognise measurable differences in clinical some of the inconsistency in defining the factors and characteris-
outcomes in patients who had a history of ankle joint injury. tics that best explain recurrent ankle sprains and instability may
Recognition of prolonged deficits in single-limb balance after be attributed to inconsistent inclusion criteria among this litera-
ankle ligament sprains led to a theory of changes in neural sig- ture. The International Ankle Consortium proposes the estab-
nalling following trauma to the ankle joint and categorisation of lishment of an accepted set of selection criteria, which should
these patients as having functional ankle instability. Several be used in this area of research, as it will provide consistency to
decades later, Hertel19 presented a model that recognised the the future data synthesis devoted to improving the understand-
contributions from functional and mechanical insufficiencies ing of CAI and enhancing the external validity of findings for
associated with an acute ankle sprain that may interact to pre- this patient population. The purpose of this position statement
cipitate the development of CAI. The development of this is to present and discuss an endorsed set of selection criteria for
model was a seminal step in facilitating an understanding of patients with CAI based on the best available evidence to be
why many patients incur repeated ankle joint dysfunction. The used in future research and study designs. Our group wishes to
use of the term CAI according to the Hertel19 model repre- advocate the pursuit of the strongest and most appropriate evi-
sented the initial attempt to define and provide potential contri- dence that will improve the understanding and management of
butions from functional and mechanical insufficiencies, which CAI.
helped develop a more comprehensive approach to researching
and treating individuals with this pathology. CRITERIA RECOMMENDATIONS
Research related to ankle joint instability evolved over the The standard inclusion and exclusion criteria endorsed by the
decade following the publication of the Hertel19 CAI model, International Ankle Consortium, as a minimum, for enrolling
with a primary aim of much of the research devoted to under- patients who fall within the heterogeneous condition of CAI in
standing exactly what combinations of functional and mechan- controlled research are listed in boxes 1 and 2. Additionally, the
ical insufficiencies best define CAI. Many recent reviews and International Ankle Consortium encourages the reporting of
multifactorial studies have provided important information out- critical information found in table 1 for patients with CAI to
lining that there are multiple potential contributing mechanical, provide a comprehensive description of the study participants
neuromuscular, functional and/or perceived deficits that may who have been enrolled in controlled research studies.
persist long after physiological tissue healing times have elapsed
and interventions have been completed following an acute ankle DISCUSSION
joint sprain.23–34 Consistently, these reviews and multifactorial The preceding endorsed criteria for selection of individuals with
studies support the proposition that CAI is a multifaceted and CAI in research are based on the best available evidence, and
complex condition requiring a further in-depth interdisciplinary the International Ankle Consortium recommends adherence to
study. produce consistent population characteristics for improved out-
Although the volume and quality of this research grew sub- comes and external validity in future research of this clinical
stantially, it became more evident that individuals with CAI are phenomenon. These recommendations will enhance the validity
quite heterogeneous in their presentation of impairments, of research conducted in this clinical population with the end
leading the research towards consideration of a possible con- goal of bringing the research evidence to the clinician and
glomeration of subgroups. Recently, Hiller et al21 introduced patient. Additional rationale for the selection criteria will be
an update of Hertel’s19 CAI model that suggests that there may provided below.
be as many as seven different subsets of patients who incur The International Ankle Consortium acknowledges the work
persistent symptoms following an initial ankle joint sprain, of Delahunt et al20 that has provided the framework for this

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Consensus statement

Box 1 Standard inclusion criteria endorsed, as a Box 2 Standard exclusion criteria endorsed, as a
minimum, by the International Ankle Consortium for minimum, by the International Ankle Consortium for
enrolling patients who fall within the heterogeneous enrolling patients who fall within the heterogeneous
condition of chronic ankle instability in controlled condition of chronic ankle instability in controlled
research. research.

Inclusion criteria Exclusion criteria

1. A history of at least one significant ankle sprain 1. A history of previous surgeries to the musculoskeletal
▸ The initial sprain must have occurred at least 12 months structures (ie, bones, joint structures and nerves) in either
prior to the study enrolment lower extremity.
▸ Was associated with inflammatory symptoms ( pain, It is understood and accepted in clinical and research practice
swelling, etc) that surgery to repair insufficient joint structures is designed to
▸ Created at least one interrupted day of desired physical restore structural integrity, but creates residual changes in the
activity central and peripheral portions of the nervous system. Even with
The most recent injury must have occurred more than 3 months appropriate rehabilitation and follow-up management, there are
prior to the study enrolment. concomitant neuromuscular and structural alterations after
We endorse the definition of an ankle sprain as “An acute surgery that would confound the ability to isolate the effects of
traumatic injury to the lateral ligament complex of the ankle chronic ankle instability.
joint as a result of excessive inversion of the rear foot or a 2. A history of a fracture in either lower extremity requiring
combined plantar flexion and adduction of the foot. This usually realignment.
results in some initial deficits of function and disability”.20 Similar to the first exclusion criterion, significant compromise to
skeletal tissue will threaten the internal validity of the selection
2. A history of the previously injured ankle joint ‘giving way’,
of study populations with isolated chronic ankle instability.
and/or recurrent sprain and/or ‘feelings of instability’.
3. Acute injury to the musculoskeletal structures of other joints
We endorse the definition of ‘giving way as “The regular
of the lower extremity in the previous 3 months, which
occurrence of uncontrolled and unpredictable episodes of
impacted joint integrity and function (ie, sprains, fractures)
excessive inversion of the rear foot (usually experienced during
resulting in at least 1 interrupted day of desired physical
initial contact during walking or running), which do not result in
activity.
an acute lateral ankle sprain”.20
Specifically, participants should report at least 2 episodes of
‘giving way’ in the 6 months prior to the study enrolment.
We endorse the definition of ‘recurrent sprain’ as “Two or
more sprains to the same ankle”.20 sprain and its subsequent sequelae; (2) identify the terminology
We endorse the definition of feeling of ankle joint instability used by authors to classify patients with CAI (eg, CAI, functional
as “The situation whereby during activities of daily living (ADL) ankle instability, MAI or others) and (3) to identify the specific
and sporting activities the subject feels that the ankle joint is inclusion criteria used by authors publishing research papers per-
unstable and is usually associated with the fear of sustaining an taining to ankle joint sprain and subsequent sequelae. This was
acute ligament sprain”.20 the first published paper to systematically investigate the afore-
Specifically, self-reported ankle instability should be confirmed mentioned issues which may lead to inconsistencies in research
with a validated ankle instability-specific questionnaire using the results relating to ankle joint sprain and its subsequent sequelae.
associated cut-off score. Currently recommended questionnaires: The results of this systematic investigation indicated that CAI was
A. Ankle Instability Instrument (AII)40: answer ‘yes’ to at the most commonly used term to describe patients who report
least five yes/no questions (This should include question ongoing symptoms after an initial ankle sprain. Furthermore, the
1, plus four others) most commonly used descriptors relating to CAI were frequent/
B. Cumberland Ankle Instability Tool (CAIT)41: score of <24 recurrent sprains and episodes of or the reporting of feelings of
C. Identification of functional ankle instability (IdFAI)37: ankle joint ‘giving way’. Based on their findings, Delahunt et al20
score of >11 recommended that consistent terminology and a specific
3 A general self-reported foot and ankle function questionnaire minimum set of criteria be reported as this would improve
is recommended to describe the level of disability of the research endeavour pertaining to CAI. As such, Delahunt et al20
cohort, but should only be an inclusion criterion if the level devised a set of operational definitions related to ankle joint
of self-reported function is important to the research sprain and its subsequent sequelae, as well as a specific set of cri-
question. Currently endorsed questionnaires: teria that should be reported when undertaking research on indi-
A. Foot and Ankle Ability Measure (FAAM)42: ADL scale viduals with CAI. These definitions and criteria set formed the
<90%; Sport scale <80% basis of discussion at the International Ankle Symposium, from
B. Foot and Ankle Outcome Score (FAOS)43: score of <75% which the International Ankle Consortium formed a consensus
in three or more categories statement relating to the operational definitions pertaining to
ankle joint sprain and its subsequent sequelae and a minimum set
of criteria to be reported when conducting CAI research.
position statement and recommends consultation of and familiar- At the fifth International Ankle Symposium (Lexington,
isation with that work by all researchers with an interest in CAI. Kentucky, USA, 2012), the International Ankle Consortium
The aims of the systematic investigation by Delahunt et al 20 executive committee discussed the concepts of this position
were to: (1) identify the definition of ankle instability used by paper based on the existing work and the new information
authors publishing research papers pertaining to ankle joint being presented at the meeting.35 Consistent with the work by

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Consensus statement

Table 1 Information recommended by the International Ankle Consortium for patients with chronic ankle instability with the goal of providing
a comprehensive description of the study participants who have been enrolled in controlled research studies
Topic Suggested content

Quality of ankle injury history 1. The number of previous ankle sprains

2. The presence and frequency of reported episodes of ‘giving way’
3. The presence and frequency of reported episodes of feelings of instability
4. The scores on the validated self-reported ankle instability instruments utilised to establish inclusion criteria
5. Severity of injury (index and most recent incidents), including the number of days of immobilisation and/or non-weight bearing
6. If diagnosis was performed by a healthcare professional or self-diagnosed
Timing of ankle sprain injury 7. The time since the most recent ankle sprain
8. The number of weeks of supervised rehabilitation by a healthcare professional
9. The number of weeks since supervised rehabilitation was completed
Potential confounding factors 10. Any included mechanical instability ratings (ie, clinical laxity scales, arthrometry measures and stress radiography)
11. A rating of the current level of physical activity level using a validated scale (eg, Tegner scale, Godin Leisure Time Physical Activity,
etc), and the minimum number of hours per week of participation in physical activity
12. Any concomitant, non-surgical injuries at the time of ankle sprain13. The frequency of use of prophylactic ankle support
14. The results of any functional or range of motion assessments
15. Presence of pain during functional activities

Delahunt et al,20 new papers presented at the International subgroups of individuals with CAI who most likely provide
Ankle Symposium emphasised the strength of the reported epi- better homogeneity in describing the pathology. Of the three
sodes of ‘giving way’ and patient-reported instability in defining primary separation factors, the authors suggested that mechan-
CAI. Snyder et al,36 using the Delphi method to gather input ical instability provided the weakest contribution. Additionally,
from expert clinicians and researchers, reported that the ‘recur- hypomobility, rather than joint laxity, contributes more to the
rent sense of giving way’ was the strongest characteristic in subgroup model creation. It appears that mechanical instability
defining CAI. However, there are other characteristics such as may be a factor in some patients that leads to recurrent ankle
feelings of instability and recovery from a ‘rolling over’ inci- injury and measures of perceived ankle instability, but these are
dent37 that are important in identifying who has CAI and estab- not necessarily dependent on the presence of ankle hypermobi-
lishing the severity of the condition that is not obtained through lity. Data from other multifactorial studies that have included
the reporting of ‘giving way’ alone. A series of studies38 39 measures of mechanical instability in patients with CAI suggest
support the use of condition-specific self-report questionnaires that mechanical instability alone is not a consistent identifier of
to identify those with the minimal accepted criteria for ankle this pathology.28 33
instability. It is critical to use condition-specific questionnaires A recent advancement in the CAI literature has been the
that are both valid and reliable37 40 41 in the collection of this stratification of individuals based on the structural and func-
information. This recent work highlights the increasing evidence tional impairments associated with ankle instability. Multiple
for the selected criteria we introduced in this position paper. studies by Brown et al44–46 compared sensorimotor and bio-
Additionally, measurement of self-reported instability should mechanical measures between patients classified as having MAI,
be differentiated from measurement of resulting change to phys- functional ankle instability and copers (no measurable ankle
ical function or quality of life. Changes to physical function instability or repeated injury). While the presence of mechanical
may be a result of any or all mechanical insufficiencies, self- laxity was associated with some proximal joint sensorimotor
reported instability and recurrent sprains. Therefore, if investi- alterations and increases in ground reaction forces during
gators are interested in the deficits present in participants with landing tasks compared with the other groups, these differences
CAI, such as strength, neuromuscular or proprioception deficits were not observed consistently. It is also interesting to note that
as examples, measures of self-reported function may not be a the MAI groups had more self-reported disability and no differ-
necessary inclusion criterion for this type of study. However, if ences in the number of episodes of ‘giving way’ as compared
functional impairment is relevant to the proposed project or with the functional ankle instability groups, suggesting that the
intervention, then validated ankle-specific questionnaires that MAI groups had similar, if not more, functional instability than
were designed to evaluate self-reported function should be used the functional ankle instability groups did. The design of these
to create the necessary inclusion criterion.42 43 studies to separate MAI and functional ankle instability repre-
Our recommended inclusion criteria are based on assessments sents the needed comparisons required to glean the factors that
of injury history, function and disability, but we recognise the best define CAI. The information would seem to lend support
lack of a definitive selection criteria based on an assessment of to the strength of the contribution of functional instability mea-
joint integrity or laxity. While an initial ankle sprain often threa- sures, rather than mechanical instability, to defining CAI.
tens the integrity of ligamentous structures and some authors
have reported lingering ankle laxity, hypomobility and hypermo- Future considerations
bility, these outcomes do not appear to be observed consistently We have provided recommendations for the selection of patients
in patients with CAI. Previous authors have considered mechan- with CAI to improve the quality of research on this pathology.
ical instability as an explanatory factor for lingering ankle The healthcare burden associated with ankle instability necessi-
instability, but there has not been a definitive association of tates increased research and clinical outcomes that can be used
ankle laxity with CAI.19–21 23 28 29 33 44 45 to reduce the disability and recurrence rates associated with
Hertel’s19 original model differentiated mechanical instability CAI. It is clear from the body of literature that there are many
from functional instability. More recently, Hiller et al,21 refining contributing factors to CAI that can create a host of impair-
the model of categorising CAI, suggests as many as seven ments19 20 23 26 28 29 32 33; however, this condition is more

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Consensus statement

heterogeneous than many realise.20 21 Therefore, researchers Competing interests None.

need to be cognisant of criteria that are best associated with CAI Provenance and peer review Not commissioned; internally peer reviewed.
based on the current available evidence. Based on the collective
expertise of the International Ankle Consortium, we feel that
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Selection criteria for patients with chronic

ankle instability in controlled research: a
position statement of the International Ankle
Consortium
Phillip A Gribble, Eamonn Delahunt, Chris Bleakley, Brian Caulfield,
Carrie Docherty, François Fourchet, Daniel Tik-Pui Fong, Jay Hertel,
Claire Hiller, Thomas Kaminski, Patrick McKeon, Kathryn Refshauge,
Philip van der Wees, Bill Vincenzino and Erik Wikstrom

Br J Sports Med2014 48: 1014-1018 originally published online

November 19, 2013
doi: 10.1136/bjsports-2013-093175

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