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Wang et al.

Journal of Orthopaedic
Journal of Orthopaedic Surgery and Research (2023) 18:936
https://doi.org/10.1186/s13018-023-04367-3 Surgery and Research

STUDY PROTOCOL Open Access

Effectiveness of a digital rehabilitation


program based on computer vision
and augmented reality for isolated meniscus
injury: protocol for a prospective randomized
controlled trial
Li Wang1†, Xi Chen1†, Qian Deng1, MingKe You1, Yang Xu1, Di Liu2, Ye Lin3, PengCheng Li1,4* and Jian Li1*

Abstract
Background The lack of access to physical therapists in developing countries and rural areas poses a significant chal-
lenge in supervising postsurgical rehabilitation, potentially impeding desirable outcomes following surgical interven-
tions. For this reason, this study aims to evaluate the feasibility, safety, and effectiveness of utilizing a digital rehabilita-
tion program based on computer vision and augmented reality in comparison with traditional care for patients who
will undergo isolated meniscus repair, since to date, there is no literature on this topic.
Methods This study intends to enroll two groups of participants, each to be provided with informed consent
before undergoing randomization into either the experimental or control group. The experimental group will
undergo a digital rehabilitation program utilizing computer vision and augmented reality (AR) technology follow-
ing their surgical procedure, while the control group will receive conventional care, involving in-clinic physical therapy
sessions weekly. Both groups will adhere to a standardized rehabilitation protocol over a six-month duration. Follow-
up assessments will be conducted at various intervals, including preoperatively, and at 2 weeks, 6 weeks, 12 weeks,
and 24 weeks postoperatively. Imaging assessments and return-to-play evaluations will be conducted during the final
follow-up. Clinical functionality will be assessed based on improvements in International Knee Documentation Com-
mittee (IKDC) and Visual Analog Scale (VAS) scores.
Registration number ChiCTR2300070582.
Keywords Computer vision, Augmented reality, Meniscus, Rehabilitation


Li Wang and Xi Chen have contributed equally to this work and share the
first authorship.
*Correspondence:
PengCheng Li
16699411@qq.com
Jian Li
lijian_sportsmed@163.com
Full list of author information is available at the end of the article

© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
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mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 2 of 7

Introduction The protocol of the digital rehabilitation program is


The lateral and medial menisci protect articular carti- based on the concept of accelerated rehabilitation after
lage by providing shock absorption, distributing load, meniscal surgery proposed in 1996, suggesting that early
and lubricating the articular surface. Injury to the postoperative weight bearing and knee range of motion
meniscus is prevalent among young and athletic indi- (ROM) could reduce the risk of joint adhesions and mus-
viduals, causing biomechanical alterations of the joint, cle atrophy [5]. In recent years, accelerated rehabilita-
resulting in increased joint contact stress and possibly tion programs for early weight bearing and active ROM
precipitating early degenerative changes and osteoar- after meniscus repair have shown positive results in
thritis [1, 2]. Studies have established that meniscec- patients with longitudinal meniscus tears [1, 2, 17]. Fur-
tomy increases the likelihood of accelerated knee ther research is warranted to investigate the safety and
osteoarthritis; thus, arthroscopic procedures with efficacy of early weight bearing and ROM training in
suturing or meniscoplasty (central meniscal resection) patients who undergo complex meniscal tear repair, as
are usually employed to preserve as much meniscal tis- the rehabilitation strategies may vary depending on tear
sue as possible, depending on the shape of the damaged pattern. [2, 18]
meniscus [1–4]. As a result, this study will utilize computer vision and
Postoperatively, physical therapy plays a pivotal role smartphone-based augmented reality to overcome the
[5]. However, a significant challenge arises from the lim- limitations associated with conventional postoperative
ited access to skilled therapists in developing countries rehabilitation methods, with the goal of enhancing ortho-
and remote rural areas [6–8]. Patients in these resource- pedic postoperative outcomes. This study will involve
constrained regions often face long commutes to health- delivering standardized exercise protocols using a digital
care facilities, reduced compliance with rehabilitation platform, providing patients with continuous and effec-
protocols, and a lack of monitoring during the postopera- tive physical therapy training supplemented by real-time
tive phase [6]. Consequently, recognizing the limitations feedback. Notably, there is currently no literature report-
inherent in conventional clinic-based physical therapy ing the application of augmented reality and computer
practice, digital rehabilitation programs will emerge as a vision for postoperative recovery in patients with isolated
promising supplemental solution. [7, 9] meniscus injuries.
Advanced technologies such as augmented reality and
computer vision will have the potential to offer interactive Aim of study
digital therapy experiences [10]. Currently, the utilization This study will recruit adult participants diagnosed
of the VR system facilitates home-based rehabilitation with isolated longitudinal meniscus injuries confirmed
training and increases its interactivity and enjoyment. through arthroscopic examination and scheduled for
[11–15] However, in VR, patients interact with a virtual meniscus repair. The primary objective of this research is
environment that simulates real-life activities. The risk to assess the safety, effectiveness, and feasibility of imple-
associated with this technology is that potentially dan- menting a digital rehabilitation program that incorpo-
gerous situations may not be appropriately identified; rates computer vision and augmented reality as part of
however, images portrayed in both AR and virtual reality the postoperative rehabilitation process.
overlap with real-world images, thus allowing patients to
be aware of potential dangers. [10] The incorporation of Methods
both virtual and real-world elements combined with real- Study design
time interaction and standard rehabilitation protocols This is a single-center, prospective, randomized con-
can be leveraged to promote the recovery of an injured trolled study. After receiving informed consent, partici-
joint [15]. Telerehabilitation using technologies such as pants will be randomly allocated into two groups: the
computer vision (CV) offers the potential for improving experimental group and the control group will adopt
access to rehabilitation programs. The use of marker- the standardized rehabilitation protocol (Table 1). The
less human pose estimation based on computer vision in experimental group will engage in a digital rehabilitation
telerehabilitation is a promising research area, as it offers program that can be completed from home, whereas the
the advantage of closely monitoring movement without control group will attend weekly physical therapy clinic
the need for external markers to capture motion data sessions for exercise guidance. The flowchart of the study
[16]. In our study, AR technology will utilize readily avail- is shown in Fig. 1.
able devices such as smartphones, eliminating the need
for additional hardware and providing greater conveni- Randomization
ence, while computer vision will facilitate real-time mon- SPSS 23.0 (IBM, New York, NY, USA) will be used to
itoring of patient movements and exercise postures. generate random numbers. Subjects with odd numbers
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 3 of 7

Table 1 The standardized postoperative rehabilitation plan

Overall goal: Stage 1: 0–2 weeks: Control of swelling and symptoms after surgery, early progressive weight bearing, and ROM
Control of swelling and symptoms: (1) apply ice at least 3 times a day after surgery, 20 min each time; (2) apply the elastic bandage to compress
the affected limb; (3) elevate the affected limb and lie flat on your back when sleeping and cushion a pillow with a certain thickness under the affected
limb
ROM and brace use: (1) 0–60 degree fixation, early gentle knee movement under sitting position (2) heel support training, ensuring knee joint at 0
degrees
Weight bearing: The knee brace is secured in the fully extended knee position, and crutches are used to transition from no weight bearing to partial
weight bearing as tolerated
Exercises: (1) sitting hamstring pull (2) ankle pump (3) quadriceps isometric training (4) straight leg elevation training (15–30 degrees) (5) hamstring
isometric training
Overall goal: Stage 2:3–6 weeks: Early exercise and strength training, ROM, and partial weight bearing as tolerated
ROM and support use: (1) 3–4 weeks: 0–90-degree fixation, complete knee extension and bend to 90 degrees (2) 5–6 weeks 0–120-degree fixation,
bend to 120 degrees
Weight bearing: With the knee brace fixed in the fully extended knee position, and using crutches, gradual weight bearing to full weight under toler-
able conditions, and gradually remove of the crutches
Exercise: In addition to the training in the previous stage, include: (1) knee shin slide (2) supine straight leg raise 30 to 60 degrees (3) hip outreach train-
ing (4) lift heel stand (5) hip outreach (6) hip and (7) seat after knee flexion and stand
Overall goal: Stage 3: Weeks 7–12: Functional regression, gradual reduction of brace use, and restoration of total joint range of motion
ROM and brace use: (1) restore full joint range of motion and (2) gradually stop brace use after full weight bearing
Exercise: Add advanced resistance training: (1) recumbent resistance straight leg raise (2) step-down training (3) heel raise training (4) knee flexion (5)
straight leg draft with elastic band (6) recumbent resistance heel slide (7) forward lunge (8) half squat against wall 50 degrees (9) four-point kneeling
cross stretch
Overall goal: Stage 4: Weeks 13–24: Early exercise training, full-strength recovery, cardiovascular exercise adaptation, and exercise-specific training
(speed and agility training)
Exercise: Continue with the third stage of training and build on this cardiovascular endurance training (power cycling, recovery running, and jumping)
Phase 5: after return to sports assessment to determine whether to return to body contact, rotating sports

allocation scheme will be stored in an opaque enve-


lope, which will be opened in succession according to
the order of inclusion, thereby determining the assigned
group for each patient. After that, the envelopes will be
given to the study implementer, who will then use inclu-
sion and exclusion criteria to decide whether each patient
can be included in the study.

Blinding method
For this study, blinding of the interveners and patients
was not feasible. Blinding should be applied to the data
collectors, data analysts, and outcome assessors in the
study.

Subjects
Inclusion criteria:

(1) Isolated meniscus injury diagnosed by magnetic


Fig. 1 Research flowchart resonance imaging (MRI)
(2) Confirmation of a longitudinal tear pattern (includ-
ing bucket handle tears) under arthroscopy, with a
repairable tear.
will be assigned to the experimental group, and subjects (3) Suture meniscus repair with or without partial
with even numbers will be assigned to the control group. meniscectomy
The envelope method will be used for hidden grouping, (4) Participants have sustained their meniscus injury
which will be implemented by a third party. The random due to physical activities, such as playing basketball.
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 4 of 7

(5) Willing to participate in this clinical trial and


receive follow-up.

Exclusion criteria:

(1) Preoperative MRI diagnosis with other ligament or


chondral lesions;
(2) A discoid meniscus was diagnosed under arthros-
copy.
(3) Trauma and surgery to other weight-bearing joints
in the lower extremities, such as torn ligaments in
the ankle and necrosis of the femoral head in the
hip, can indirectly affect knee load and movement.
(4) Knee osteoarthritis, defined by Kellgren–Lawrence
grade II or higher or Outerbridge classification
grade II and above. [19, 20]

Fig. 2 The camera system


Sample size
The sample size is calculated based on the calculation
method of a pilot study [21], and the effect size is calcu-
lated as follows: d = 0.8; α = 0.05; Power = 0.8. The mini- time (Fig. 2). As the patient performs the physical therapy
mum sample size per group is 26, and the estimated loss exercises, the system will provide demonstration vid-
of follow-up/exit rate is 20%. Thus, a maximum of 32 par- eos, verbal and auditory feedback on the patient’s exer-
ticipants will be recruited for each group. cise posture and duration. The digital platform will also
record the patient’s exercise frequency and duration. This
Intervention measures data will then be transmitted to the software platform for
Surgical procedure detailed analysis by the research team.
All surgeries will be performed by 1 designated surgeons
from our center. These designated surgeons are required Smartphone camera requirements
to undergo a meniscal surgical technique evaluation and It is recommended to have a photo resolution of
register with the center before being permitted to par- 1280 × 720 pixels or higher and a video frame rate of 30
ticipate in the study and perform surgeries. Arthroscopic frames per second or higher for the smartphone camera.
surgery will be performed under general anesthesia. If
repairable meniscal lesions are found in the patient, the Environment
lesions will be first cleared using a shaver for freshen- The environment in which the camera is placed should
ing. All patients will receive a full-endoscopic meniscal have appropriate lighting conditions. Adequate natural
repair technique, and if the meniscus is not repairable, light or suitable illumination can enhance image quality
the partial meniscectomy can be performed to reshape and recognition accuracy. The camera should be placed
the meniscus. in a stable position to avoid image blurring. The cam-
era’s position should be adjusted to capture the patient
Postoperative rehabilitation protocol
in the frame. Ensure that the camera’s field of view is
A standardized postoperative rehabilitation protocol will unobstructed.
be adopted according to the clinical guidelines in the
Human pose detection model
American Academy of Orthopaedic Surgeons (AAOS)
postoperative rehabilitation manual18 and previous stud- The human pose detection model (Fig. 3) will detect
ies1,2,4,14 (Table 1). [1, 2, 4, 18, 22] critical anatomical landmarks on the human body using
images or videos captured by a smartphone camera. By
employing a convolutional neural network (CNN) algo-
Experimental group
rithm, this model can identify various joints, includ-
Patients will receive daily exercise plans via a software
ing the shoulder, elbow, wrist, hip, knee, and ankle. It
platform for 12 weeks. This software can be installed on
will then generate a 3D skeletal model (Fig. 4), tracking
the patients’ smartphones. Once the patient initiates the
dynamic changes in the patient’s body position during
digital therapy platform, the system will utilize the smart-
motion.
phone’s camera to capture the patient’s position in real
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 5 of 7

Fig. 3 Human pose detection model recognizing knee flexion

Fig. 4 3D skeletal model reconstruction

When the model detects exercise postures that devi- then be asked to take the instruction sheet home to
ate from preset values, it will provide auditory and ver- complete the remaining exercises.
bal feedback via the software to remind the patient to
adjust their position based on the instructional video. Compliance
Hence, the patient will receive interactive feedback To increase compliance, patients will receive ade-
during the training process. quate education on software usage before the start of
the trial. Throughout the trial, patients will receive
detailed instructions via handouts and reminders via
Control group texts and calls. Support will be provided to patients to
Patients will be referred to the clinic weekly for answer questions throughout the trial. Compliance data
12 weeks postoperatively, during which they will receive will be monitored based on software usage data and
instructions on physical therapy exercises. Every week, patient attendance data in the clinic. The research team
patients will learn the exercises at the clinic and will will collect data on patients’ training frequency and
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 6 of 7

duration to objectively assess participant compliance examined; MRI (T1-weighted and T2-weighted images
within the study. of axial, coronal and sagittal positions): 1 day before sur-
gery, 6 months after surgery. The imaging assessment
Outcomes was conducted in a blinded manner, and the evaluators
Clinical knee function evaluation were not informed of the identity and grouping of the
The estimated follow-up time was 1 day before sur- patients. Imaging evaluation should be performed with-
gery and 2, 6, 12, and 24 weeks after surgery, and the out intervention.
specific evaluation items included knee ROM (2, 6, 12,
24 weeks after surgery), weight-bearing progress (when Complications assessment
fully weight bearing) and knee function and pain scores Postoperative complications, such as postoperative knee
[23] (Lysholm score, Tegner score, IKDC knee subjective infection, deep venous thrombosis of the lower limbs,
function score, and VAS score). At the final follow-up stiffness, and arthrofibrosis, will be recorded.
assessment, return-to-play (RTP) status will be evaluated
based on the rehabilitation literature available for menis- Statistical analysis
cus repair. (Table 2). [4, 24, 25] Quantitative data will be analyzed using SPSS 21.0 (IBM,
The clinical function of patients was assessed and New York, NY, USA). The demographic, social, and pre-
evaluated based on IKDC and VAS score improvement clinical characteristics of the subjects in both groups will
via the criteria of minimal clinically important differ- be described. Differences in these variables between the
ence (MCID), patient accepted symptom state (PASS), intervention and control groups will be analyzed using
and significant clinical benefit (SCB) [25].According to either the Chi-square test or the T test, with continuous
the study of Gowd et al. [25], the MCID threshold, which variables recorded as the mean and standard errors and
represents the minimal clinically important difference, is categorical variables as rates (incidence). For continu-
defined as an improvement of at least 10.6 points in the ous variables, the Shapiro‒Wilk test will be performed
IKDC score after treatment or intervention. This thresh- to verify that the variables in each group obeyed a nor-
old signifies that a clinically meaningful change in knee mal distribution. For repeated measures, 2-way ANOVA
joint function is recognized. The SCB threshold, indicat- analysis will be conducted. Two independent samples
ing significant clinical benefit, is set at an IKDC score mean comparison T tests were used to compare the nor-
of 27.3 points or higher after treatment or intervention. mally distributed continuous variables between groups.
This threshold is used to confirm that the treatment has For nonparametric variables, the Kruskal‒Wallis test was
brought about a significant clinical benefit. Lastly, the used to determine the differences between the groups.
threshold for patient accepted symptom state (PASS) is Chi-square tests and Fischer exact tests were used to
established at an IKDC score of 57.9 points or higher. determine differences in categorical variables. Statistical
This threshold signifies that patients subjectively con- significance was set at p < 0.05.
sider their symptom state to be acceptable.
Adverse event management
Radiographic evaluation In this study, inadequate healing of the meniscus may be
Evaluation time point and project: X-ray: 1 day before observed following suturing. After a 6-month postopera-
surgery, 1 day, and 6 months after surgery; the anter- tive MRI review and clinical evaluation, some patients
oposterior and lateral position of the knee joint was may require an arthroscopic review to confirm meniscus

Table 2 Return-to-play assessment

VAS score = 0
IKDC score > 90
No active effusion (Brush test negative)
The difference in circumference between the quadriceps muscles was less than 1.5 cm
The knee isokinetic strength test showed a ratio of bilateral quadriceps muscles greater than 90%, bilateral hamstrings greater than 90%, and uni-
lateral hamstrings to quadriceps muscle greater than 66%
Jump test Limb symmetry index (LSI = jump distance on the affected side/jump distance on the healthy side *100%) was greater than 90%,
and the test items included a single-leg long jump test and a single-leg triple jump test
Y-word balance test: bilateral extension asymmetry within 4 cm; bilateral comprehensive score is greater than 90%
Lateral step-down test showed no dynamic genu valgus
Wang et al. Journal of Orthopaedic Surgery and Research (2023) 18:936 Page 7 of 7

healing. If the repair of the meniscus is unsuccessful, then self-efficacy, engagement, and barriers among physical therapists in the
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partial meniscectomy will be undertaken. 1365-​2753.​2012.​01849.x.
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LW and XC are the primary designers of the research. All authors have made https://​doi.​org/​10.​2519/​jospt.​2022.​11384.
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Funding 11. Zeng X, Zhu G, Zhang M, Xie SQ. Reviewing clinical effectiveness of active
Funding for this research project is provided by the Sichuan Science and training strategies of platform-based ankle rehabilitation robots. J Healthc
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the development of intelligent wearable devices and remote 5G technology of knee cartilage. Radiology. 2021;301:423–32. https://​doi.​org/​10.​1148/​
sports and rehabilitation platform." The fund number is 2022YFS0372. radiol.​20212​04587.
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Availability of data and materials patients with knee and hip osteoarthritis. J Clin Med. 2020;9:2639. https://​
The datasets used or analyzed during the current study are available from the doi.​org/​10.​3390/​jcm90​82639.
corresponding author upon reasonable request. 14. Gazendam A, Zhu M, Chang Y, Phillips S, Bhandari M. Virtual reality
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Declarations
Traumat Arthrosc Off J ESSKA. 2022;30:2548–55. https://​doi.​org/​10.​1007/​
s00167-​022-​06910-x.
Ethics approval and consent to participate
15. Li L. Effect of remote control augmented reality multimedia technology
This study has been registered at the Chinese Clinical Trial Registry (ChiCTR)
for postoperative rehabilitation of knee joint injury. Comput Math Meth-
website; Registration number: ChiCTR2300070582. This study was approved
ods Med. 2022;2022:9320063. https://​doi.​org/​10.​1155/​2022/​93200​63.
by the Clinical Trial Ethics Review Committee of West China Hospital of
16. Hellsten T, Karlsson J, Shamsuzzaman M, Pulkkis G. The potential of com-
Sichuan University.
puter vision-based marker-less human motion analysis for rehabilitation.
Rehabil Process Outcome. 2021;10:11795727211022330. https://​doi.​org/​
Competing interests
10.​1177/​11795​72721​10223​30.
Di Liu is an employee of Jiakang Zhongzhi Technology Company.
17. Lind M, Nielsen T, Faunø P, Lund B, Christiansen SE. Free rehabilitation
is safe after isolated meniscus repair: a prospective randomized trial
Author details
1 comparing free with restricted rehabilitation regimens. Am J Sports Med.
Department of Orthopaedics, Orthopaedic Research Institute, West China
2013;41:2753–8. https://​doi.​org/​10.​1177/​03635​46513​505079.
Hospital, Sichuan University, No 37 Guo Xue Xiang, Chengdu 610041, Sichuan,
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People’s Republic of China. 2 Jiakang Zhongzhi Technology Company, Beijing,
tion and outcomes following arthroscopic isolated meniscus repairs: a
People’s Republic of China. 3 University of Chicago, Chicago, USA. 4 China
systematic review. Phys Ther Sport. 2020;45:76–85. https://​doi.​org/​10.​
School of Nursing, Sichuan University, Chengdu, People’s Republic of China.
1016/j.​ptsp.​2020.​06.​011.
19. Kohn MD, Sassoon AA, Fernando ND. Classifications in brief: Kell-
Received: 6 September 2023 Accepted: 12 November 2023
gren–Lawrence classification of osteoarthritis. Clin Orthop Relat Res.
2016;474:1886–93. https://​doi.​org/​10.​1007/​s11999-​016-​4732-4.
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