A
The efficacy and cost-effectiveness analysis of telerehabilitation for patients after arthroscopic ACL-reconstruction: a non-inferiority randomized controlled trialA
ChenruiYuan
Ph.D.
1CaiqiXu
M.D.
1LihuaHuang2
M.M.1
YaohuaHe
Ph.D.
1✉,4Phone+8618930177339Emailheyaohua@sjtu.edu.cnShengdiLu
M.D.
3✉,4Phone+8613916482184Emaillushengdi@shsmu.edu.cn1Department of Sports MedicineShanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of MedicineShanghaiChina
2Department of RehabilitationShanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of MedicineShanghaiChina
3Department of OrthopedicsShanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of MedicineShanghaiChina
4No 600 Yishan RoadShanghaiChina
Chenrui Yuan1*, Ph.D., Caiqi Xu1*, M.D., Lihua Huang2, M.M., Yaohua He1#, Ph.D., Shengdi Lu3#, M.D.
#Correspondence should be addressed to Shengdi Lu and Yaohua He. Both Shengdi Lu and Yaohua He are the corresponding author of this manuscript, Shengdi Lu is the primary corresponding author responsible for the majority of the correspondence and inquiries regarding this manuscript.
Author's affiliation:
1. Department of Sports Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
2. Department of Rehabilitation, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3. Department of Orthopedics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Correspondence author's contact details:
Shengdi Lu, M.D.
Affiliation: Department of Orthopedics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Address: No 600 Yishan Road, Shanghai, China.
Email: lushengdi@shsmu.edu.cn
Phone: +8613916482184
Yaohua He, Ph.D.
Affiliation: Department of Sports Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Address: No 600 Yishan Road, Shanghai, China.
Email: heyaohua@sjtu.edu.cn
Chenrui Yuan Ph.D. and Caiqi Xu M.D. contributed equally to this work.
Phone: +8618930177339
Abstract
Purpose
This study aimed to assess the clinical and cost-effectiveness of telerehabilitation (TELE) compared to face-to-face rehabilitation (FTF) in patients following arthroscopic ACL reconstruction. Given the increasing demand for accessible rehabilitation methods, this trial investigates the feasibility of implementing TELE in a middle-income country like China.
Methods
A
A prospective, randomized controlled trial (RCT) was conducted with 68 participants randomly assigned to either TELE or FTF rehabilitation. Participants were followed for 12 weeks, with assessments at baseline, 6 weeks, and 12 weeks after surgery. Primary outcomes included knee function (measured using the International Knee Documentation Committee Subjective Knee Form, IKDC). Secondary outcomes included pain, mobility, and functional status. Cost-effectiveness was analyzed using the incremental cost-effectiveness ratio (ICER).Results
Both groups showed similar improvements in clinical outcomes, with no significant differences in IKDC scores, pain levels, or range of motion at 12 weeks. However, TELE rehabilitation was significantly less expensive, with a total cost of 58,303.18 CNY compared to 82,358.90 CNY for FTF (p < 0.001). The ICER analysis demonstrated that TELE was a cost-effective alternative, with substantial cost savings per unit of effectiveness.
Conclusion
Telerehabilitation offers a cost-effective and clinically comparable alternative to traditional face-to-face rehabilitation following ACL reconstruction. These findings support the broader implementation of TELE in regions with limited access to in-person rehabilitation, especially in low- and middle-income countries like China. Further studies with longer follow-up periods are needed to confirm the long-term cost-effectiveness and health benefits of TELE.
Keywords:
anterior cruciate ligament reconstruction
tele-rehabilitation
cost-effectiveness analysis
non-inferiority randomized controlled trial
Background
The anterior cruciate ligament (ACL) is one of the key stabilizing structures in the knee joint and is also one of the most susceptible to injury. Studies show that ACL injuries are the most common findings in arthroscopic examinations following knee injuries1–3. Statistics from abroad indicate an incidence rate of about 60 cases per 10,000 people per year. The primary cause of ACL injuries is sports-related, accounting for over 70%, with the highest incidence in basketball and football players1–3. Additionally, ACL ruptures are more common among professional athletes in judo, wrestling, and track and field, as well as among amateurs in skiing, badminton, and volleyball2. Currently, most treatments involve arthroscopic ACL reconstruction using autografts or allografts3–4. Follow-up study at 2, 3, and 5 years post-operation show that both grafts achieve satisfactory clinical outcomes in terms of knee stability, muscle strength, and postoperative activity levels, with no significant difference in clinical effectiveness between them5.
Postoperative rehabilitation training also determines the functional recovery after arthroscopic ACL surgery. Rehabilitation for the surgery can begin with education and guidance before the operation and should be implemented immediately after the surgery. The rehabilitation and training program of arthroscopic ACL reconstruction is a mature and standardized rehabilitation process.
Telerehabilitation refers to the delivery of rehabilitation medical services across regions using a combination of computer and communication technologies, remote sensing, remote control, and information processing technologies6. In telerehabilitation, therapists cannot physically touch patients, which limits techniques such as palpation, movement examination, guidance in movement training, and comprehensive observation6,7. However, this can be mitigated with techniques used in tele-rehabilitation, such as wearable smart devices, assisting patients to adjust the camera for better observation, and using the patient's own hands for palpation6,7.
Both telerehabilitation and traditional face-to-face rehabilitation can complete assessments and treatments, and are effective in health education and movement guidance. Telerehabilitation has certain advantages over face-to-face rehabilitation: 1) It breaks geographical barriers, providing convenience for patients/clients far from rehabilitation centers or with difficult commutes. 2) It offers convenience to patients/clients who find it extremely difficult to move or leave their homes due to injury or illness, such as those unable to use stairs post-surgery and without elevator access. 3) It benefits long-term home-based rehabilitation patients, reducing time and travel expenses. 4) It facilitates expert consultations (via remote video conferences). Studies from abroad indicate that tele-rehabilitation shows no significant difference from traditional offline rehabilitation in terms of treatment and postoperative recovery, and it can significantly save patients' time while achieving the same rehabilitation and postoperative recovery results6–8.
Despite the methodological differences in studies and the health care system of various countries, understanding the clinical outcomes and the economic costs of telerehabilitation interventions may improve their efficiency. The use of telerehabilitation in low and middle-income countries such as China is just emerging. As a result, data on the clinical and cost-effectiveness of telerehabilitation are scarce9,10. To date, we are not aware of any study that has investigated the clinical and cost-effectiveness of physiotherapy using telerehabilitation in these countries. To study the clinical and cost-effectiveness of telerehabilitation, we developed a telerehabilitation-based intervention for patients after arthroscopic ACL reconstruction. This study, therefore, assessed the clinical and cost-effectiveness of telerehabilitation-based intervention (TELE) compared with in-clinic face-to-face rehabilitation (FTF) for patients after arthroscopic ACL reconstruction in China.
Material and Methods
Study Design
This was a prospective, two-armed, open-labelled, randomised, controlled, single-centre clinical trial. The assessors were blinded. This RCT adhered to the Consolidated Standards of Reporting Trials (CONSORT). It was conducted from November 2nd, 2022, and July 15th, 2023, in biggest trauma center in Shanghai (Shanghai Jiao Tong University affiliated Sixth People’s Hospital). Just before hospital discharge, participants who underwent arthroscopic ACL reconstruction were randomly assigned to two groups: the in-home telerehabilitation group (TELE group) and the in-clinic face-to-face rehabilitation (FTF group). Participants received a 12-week intervention were followed up for 12 weeks. Participants were evaluated at baseline (before surgery), during the intervention (6 weeks after discharge), and at the end of intervention (12 weeks after discharge).
Participants
The inclusion criteria were as follows: (1) patients aged 18 to 60; (2) diagnosed as unilateral primary ACL injury (may be combined with meniscus injury); (3) underwent unilateral arthroscopic ACLR surgery using autologous tendon; (4) participated in sports regularly; (5) normal access to smart devices.
The exclusion criteria were as follows: (1) patients with history of knee surgery on the affected side; (2) combined injury to other ligaments of the ipsilateral knee or (4) combined injury of contralateral knee (5) suffered from severe musculoskeletal disorders; (6) with existence of lower limb malformations.
A
All the participants signed an informed consent statement. This study was registered with the Chinese Clinical Trial Registry (No. ChiCTR2100053313) and was approved by the Ethics Review Committee of Shanghai Sixth People’s Hospital [No. 2022-045-(1)].Intervention
All participants received standardised rehabilitation training instructions, overseen by two trained physical therapists (see supplementary materials). Each therapist exclusively supervised one group to ensure consistency. The intervention's intensity and duration adhered to standardized guidelines provided by a panel of experts. The intervention encompassed several components, beginning with an assessment both before and after the exercise regimen. This assessment involved a structured interview and observation to evaluate the patient's progress. During each session, patients engaged in supervised exercises for approximately thirty minutes, focusing on mobility, strengthening, function, and balance.
The exercises' intensity and difficulty level were individually tailored to each patient, taking into account their tolerance and specific needs. This approach ensured that each participant received optimal care and support throughout their rehabilitation journey.
Telerehabilitation group (TELE group)
The rehabilitation program was delivered through a smartphone APP (device: Joymotiontm software, Shanghai Medmotion Medical Management Co., Ltd., Shanghai, China.) which provided participants exercise instructions, feedback on their training performance, and the real-time two-way video and audio interaction with the PT. The APP was installed by a technician on the same day of the patient’s discharge. Internet connection was provided by the patients’ own home Wi-Fi. PT at the rehabilitation center initiated the conference at the appointed time scheduled with the patient every week. The APP provides daily rehabilitation exercises with detailed instructions and records the exercise completion rates. The rehabilitation program was prescribed by the supervising PT and was assigned to the patient as “daily tasks”.
Face-to-face rehabilitation group (FTF group)
In the FTF group, after the participants were discharged, they were assigned to a rehabilitation clinic 3 to 4 times each week for 12 weeks after discharge to receive exercise guidance from physiotherapists face to face. The components of the intervention and following home exercises were prescribed according to PT’s assessment before and after exercise.
Outcome measures
At baseline, the patients' demographic and clinical characteristics, including comorbidities, were recorded. At each follow-up visit, cointerventions, health complications, adverse events, physical activity levels and patient-reported outcome measures (PROMs) were documented.
Primary outcome
The primary outcome was the International Knee Documentation Committee (IKDC) ‘Subjective Knee Form’ was completed at 12 weeks. The IKDC is a validated and self-administered questionnaire designed for patients with a variety of knee disorders that assesses knee function, symptoms and ability to engage in sports activities, with a range from 0 to 87, in which 87 indicated no limitations in daily or sporting activities11–13.
Secondary outcomes
Secondary outcome measures included the Lower Extremity Functional Scale (LEFS), 12-item Short Form Survey (SF-12), Numeric Pain Rating Scale (NPRS) during walking and knee range of motion (ROM) at 6 weeks and 12 weeks follow-up. The IKDC, LEFS, and knee ROM were used to evaluate knee function. The SF-12 is a general health questionnaire that includes 12 questions from each of the eight dimensions of the SF-3614. It is designed to perform similarly to the SF-36 but requires less time for patients to complete15. The SF-12 consists of two subscales: the Mental Component Score (MCS-12) and the Physical Component Score (PCS-12). The scores are reported as Z-scores (differences compared to the population average, measured in standard deviations) and range from to 0–100 with an average of 50 points and standard deviation of 10 points16,17. An MCS-12 score of 42 or lower may indicate clinical depression, while a PCS-12 score of 50 or lower is the recommended cut-off for the physical condition18.
Cost measures
Costs included intervention and other healthcare costs, paid help at home, informal care, work absenteeism and presenteeism and unpaid productivity costs
For estimating intervention costs, we collected data from Hospital information system (HIS) of Shanghai Jiao Tong University affiliated sixth people’s hospital and online payment system of Shanghai Medmotion Medical Management Company.
Other healthcare costs included costs related to the use of primary healthcare (eg, general practitioner), secondary healthcare (eg, hospital visits other than the initial hospital) and prescribed and over-the-counter medication. All these costs were collected from HIS.
Paid home care costs were assessed by asking participants to report the number of hours they received paid home care, which were valued by direct inquiry to patient at 6-week and 12-week follow-up. We also collected informal care costs from patients when they visited outpatient at follow-up timepoint. Informal care costs were collected through the total number of hours patients were received help from family, friends and other volunteers, and costs were calculated by multiply total hours and average hourly-income of Shanghai.
For estimating absenteeism and presenteeism costs, we used the Productivity Cost Questionnaire19. We valued the patients’ number of sickness absence days in accordance with the Friction Cost Approach (FCA; friction period = 12 weeks) using gender-specific price weights17. For presenteeism costs, we asked participants to report the total number of days that they went to work while experiencing health complaints and to report their performance level on these days on a scale ranging from 0 (not able to do anything) to 10 (able to do everything). Subsequently, we calculated the total number of presenteeism days using the following formula: Presenteeism days = ((10 − performance level)/10) * number of days with health complaints. Presenteeism days were valued using gender-specific price weights20. For estimating unpaid productivity costs, we asked participants to report the total number of hours they were unable to perform unpaid tasks (eg, chores, volunteer work and educational activities), which were valued using an average hourly-income of Shanghai 20.
Adherence and acceptability
A
Adherence was measured using several indicators: the TELE group participants' reported completion of sessions, and the attendance rate of FTF group participants at sessions21. Additionally, both groups rated their agreement with statements concerning adherence and acceptability on a scale from 0 ('strongly disagree') to 10 ('strongly agree'). Participants also provided qualitative assessments of their perceptions of the exercise protocol's outcomes21.Sample size, randomization and blinding
IKDC at 12 weeks after surgery was regarded as the primary outcome measure. The standard deviation of the pre-treatment and post-treatment IKDC scores was 11, the non-inferiority cut-off was 8.8, the test level was α = 0.05, and the power was 1 - β = 90%12,13. Through Statistical calculations, the required sample size was 54. Therefore, to account for up to a 20% withdrawal rate, a total of 64 patients were recruited.
Patients referred to Shanghai Jiao Tong University affiliated Sixth People’s Hospital suspected for ACL tear were informed about the study by the orthopaedic surgeon. At the second outpatient visit, after written informed consent, we randomized eligible patients to either telerehabilitation or in-hospital face-to-face rehabilitation using a central computer-generated randomization scheme in a 1:1 ratio with random blocks (maximum block size of six). Participants, physicians and physical therapists were not blinded.
Statistical analysis
Patient data were coded and securely stored using the hospital’s electronic data capture system, hosted on local servers. The primary analysis focused on the per protocol population and the adverse events intention-to-treat (ITT) population. Sensitivity analyses were conducted using ITT population with multiple imputation. Baseline data were reported as mean ± SD with 95% confidence intervals (CIs) unless otherwise specified. Intergroup differences in baseline characteristics were evaluated with independent sample t-tests for continuous variables and Fisher’s exact test for categorical data. All data were analyzed using SPSS Statistics version 24.0 (IBM Corp, Chicago, IL) and R version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria).
Following treatment, continuous outcomes, including questionnaire scores and functional test results, were analyzed as changes from baseline. These outcomes were compared between intervention groups at each time point using a linear mixed model for repeated measures (nlme, version 3.1–163, in R), with changes from baseline as the primary metric. The model accounted for the interaction between time and intervention, adjusted for age and sex as fixed effects, and included participants as random effects. Differences between the least squares means of the groups were estimated at each time point (emmeans, version 1.9.0, in R). The gain in the TELE group was evaluated as noninferior only if intergroup mean difference and its one-sided 95% confidence interval (CI) were less than 8.8 IKDC points. On the basis of the methodology of a noninferiority randomized trial, we tested the null hypothesis (H0) of a group difference against the alternative that the two treatments are equivalent (H1) according to our noninferiority margin of 8.8 IKDC points. Results for each time point were reported as mean value with standard deviation (SD), and differences between groups were expressed as Coefficient with two-sided 95% confidence intervals (CIs).
The incremental cost-effectiveness ratio (ICER) was used to assess the cost-effectiveness of TELE group compared with FTF group. The ICER is the differential costs and outcomes between the TELE group and the FTF group. The numerator in the cost-effectiveness ratio is the monetary cost of the TELE intervention minus the monetary cost of PT. The annual costs of the projects were calculated by converting the 12-week costs, the period used for implementation. The denominator is the IKDC gained by TELE minus the IKDC gained by FTF at 12 weeks. Bootstrapping was used for a pair-wise comparison of the mean costs and effects between the TELE and FTF groups. CIs for the mean differences in effects were obtained by bootstrapping (1000 replications). The bootstrapped cost and effect pairs were also graphically represented on a cost-effectiveness plane20.
Results
Participants
We evaluated 96 patients with arthroscopic ACL reconstruction and 68 were randomized after surgery. Demographic data were specified in Fig. 1. The average age is similar in both groups, with TELE at 29.14 years and FTF at 31.09 years (p = 0.380). The proportion of male patients is slightly higher in the TELE group (74.29%) compared to the FTF group (63.64%), but no significant difference was noted (p = 0.342). The average BMI was similar between the two groups, with 25.46 kg/m² for the TELE group and 25.01 kg/m² for the FTF group (p = 0.627). In terms of occupation, the TELE group had a higher percentage of manual workers (66.67%) compared to the FTF group (44.83%), with a p-value of 0.084, suggesting a trend but not reaching statistical significance. Educational levels were also comparable, with 62.86% of TELE participants having less than a high school education, compared to 51.52% in the FTF group (p = 0.345). Insurance type was evenly distributed between both groups, with most participants having government insurance (81.82% in TELE, 82.76% in FTF) and very few with commercial insurance or paying out-of-pocket (p = 0.970). Lachman test results and prior meniscus treatment history were similar between the two groups, with no significant differences (p = 0.479 and p = 0.877, respectively).
Fig. 1
shows the flowchart of the study, from enrolment to analysis.
IKDC scores, LEFS, SF-12 PCS and MCS, NPRS, as well as measures of knee flexion, extension, and ROM, were all comparable between the two groups, with no statistically significant differences observed (Table 1).
Sample characteristic | TELE group (N = 35) | FTF group (N = 33) | P value |
|---|---|---|---|
Age (yr) | 29.14 (9.39) | 31.09 (8.75) | 0.380 |
Male Patients (no. [%]) | 26 (74.29) | 21 (63.64) | 0.342 |
BMI (kg/m2) | 25.46 (4.03) | 25.01 (3.38) | 0.627 |
Occupation (no.[%]) | 0.084 | ||
Manual worker | 22 (66.67) | 13 (44.83) | |
Non-manual worker | 11 (33.33) | 16 (55.17) | |
Education (no.[%]) | 0.345 | ||
Lower than high school | 22 (62.86) | 17 (51.52) | |
High school and above | 13 (37.14) | 16 (48.48) | |
Insurance type (no.[%]) | 0.970 | ||
Government | 27 (81.82) | 24 (82.76) | |
Commercial | 2 (6.06) | 2 (6.90) | |
Out-of-pocket | 4 (12.12) | 3 (10.34) | |
Lachman test, positive (no.[%]) | 32 (96.97) | 27 (93.10) | 0.479 |
Previous menisus treatment (no.[%]) | 21 (63.64) | 19 (65.52) | 0.877 |
IKDC | 50.71 (11.50) | 54.09 (11.33) | 0.227 |
IKDC (MAX adjusted to 100) | 58.29 (13.22) | 62.17 (13.02) | 0.227 |
LEFS | 56.49 (10.09) | 57.64 (13.15) | 0.686 |
SF-12 PCS | 37.51 (6.04) | 36.67 (7.46) | 0.609 |
SF-12 MCS | 48.88 (9.96) | 52.48 (9.34) | 0.129 |
NPRS | 1.91 (1.40) | 1.91 (1.59) | 0.989 |
Active Knee Flexion (°) | 123.57 (11.60) | 124.79 (12.01) | 0.672 |
Active Knee Extension (°) | 1.21 (3.31) | 0.86 (2.70) | 0.653 |
Active ROM (°) | 122.73 (12.69) | 124.59 (13.74) | 0.582 |
Passive Knee Flexion (°) | 135.67 (12.13) | 136.66 (12.78) | 0.756 |
Passive Knee Extension (°) | -2.12 (3.96) | -2.59 (4.35) | 0.661 |
Passive ROM (°) | 137.79 (13.21) | 139.24 (14.95) | 0.686 |
TELE = telerehabalitation; FTF = face-to-face rehabilitation; BMI = Body Mass Index; IKDC = International Knee Documentation Committee Subjective Knee Form; LEFS: Lower Extremity Functional Scale; SF-12 = 12-item Short Form Survey; PCS = Physical Component Score; MCS = Mental Component Score; NPRS = Numeric Pain Rating Scale; ROM = Range of Motion. | |||
Primary and secondary outcomes
At 12-week follow-up evaluation, the coefficient of differences between the groups with regard to the IKDC gains, adjusted for baseline values, were near zero: (for 62 patients in the per-protocol analysis): 0.15 (95% CI: -5.81 to 6.11) for IKDC (Table 3).
Outcome | 6 weeks post surgery | 12 weeks post surgery | |||||
|---|---|---|---|---|---|---|---|
Coefficient | 95% CI | P value | Coefficient | 95% CI | P value | ||
IKDC | 3.847 | (-2.11, 9.81) | 0.206 | 0.152 | (-5.81, 6.11) | 0.960 | |
IKDC (MAX adjusted to 100) | 4.422 | (-2.43, 11.27) | 0.206 | 0.174 | (-6.67, 7.02) | 0.960 | |
LEFS | -0.811 | (-6.09, 4.47) | 0.763 | -1.711 | (-6.99, 3.57) | 0.525 | |
SF-12 PCS | -2.591 | (-6.43, 1.25) | 0.186 | -2.398 | (-6.24, 1.44) | 0.221 | |
SF-12 MCS | 2.050 | (-3.49, 7.59) | 0.468 | -0.061 | (-5.60, 5.47) | 0.983 | |
NPRS | 0.072 | (-0.72, 0.87) | 0.859 | 0.069 | (-0.73, 0.87) | 0.865 | |
Active Knee Flexion (°) | 4.683 | (-2.07, 11.44) | 0.174 | 2.852 | (-3.91, 9.61) | 0.408 | |
Active Knee Extension (°) | -1.238 | (-3.61, 1.14) | 0.307 | 0.021 | (-2.35, 2.40) | 0.986 | |
Active ROM (°) | 5.922 | (-2.03, 13.87) | 0.144 | 2.831 | (-5.12, 10.78) | 0.485 | |
Passive Knee Flexion (°) | 4.014 | (-3.14, 11.16) | 0.271 | 2.793 | (-4.36, 9.94) | 0.444 | |
Passive Knee Extension (°) | -0.961 | (-3.40, 1.48) | 0.440 | -0.193 | (-2.64, 2.25) | 0.877 | |
Passive ROM (°) | 4.975 | (-3.28, 13.23) | 0.237 | 2.986 | (-5.27, 11.24) | 0.478 | |
IKDC = International Knee Documentation Committee Subjective Knee Form; LEFS: Lower Extremity Functional Scale; SF-12 = 12-item Short Form Survey; PCS = Physical Component Score; MCS = Mental Component Score; NPRS = Numeric Pain Rating Scale; ROM = Range of Motion. | |||||||
The changes in outcomes for the TELE and FTF groups at 6 and 12 weeks after surgery are compared. At 6 weeks post-surgery, the IKDC score decreased by 5.39 points in the TELE group and by 9.24 points in the FTF group, with a p-value of 0.256, indicating no significant difference. By 12 weeks, both groups showed similar improvement, with an increase of around 8 points, and the p-value remained non-significant at 0.963. The LEFS scores showed minor decreases at 6 weeks, with no significant differences, and by 12 weeks, both groups improved (TELE by 9.15 points, FTF by 10.86 points), though this difference was not statistically significant (p = 0.560) (Table 2,3).
Outcome | 6 weeks post surgery | 12 weeks post surgery | |||||
|---|---|---|---|---|---|---|---|
TELE group (N = 33) | FTF group (N = 29) | P value | TELE group (N = 33) | FTF group (N = 29) | P value | ||
IKDC | -5.39 (13.00) | -9.24 (13.38) | 0.256 | 8.15 (13.14) | 8.00 (12.59) | 0.963 | |
IKDC (MAX adjusted to 100) | -6.20 (14.94) | -10.62 (15.37) | 0.256 | 9.37 (15.10) | 9.20 (14.47) | 0.963 | |
LEFS | -4.12 (10.80) | -3.31 (13.20) | 0.791 | 9.15 (10.76) | 10.86 (12.21) | 0.560 | |
SF-12 PCS | -1.71 (7.96) | 0.88 (7.26) | 0.188 | 3.28 (8.89) | 5.67 (8.80) | 0.291 | |
SF-12 MCS | 0.19 (9.46) | -1.86 (14.44) | 0.506 | 3.31 (9.66) | 3.37 (12.75) | 0.983 | |
NPRS | -0.27 (1.82) | -0.34 (1.84) | 0.878 | -1.00 (1.50) | -1.07 (1.46) | 0.856 | |
Active Knee Flexion (°) | -11.45 (15.92) | -16.14 (17.70) | 0.277 | 2.58 (12.00) | -0.28 (13.01) | 0.373 | |
Active Knee Extension (°) | 2.73 (5.88) | 3.97 (5.57) | 0.400 | -0.15 (3.18) | -0.17 (3.89) | 0.982 | |
Active ROM (°) | -14.18 (19.24) | -20.10 (21.02) | 0.251 | 2.73 (12.63) | -0.10 (14.78) | 0.419 | |
Passive Knee Flexion (°) | -13.85 (17.57) | -17.86 (17.70) | 0.375 | 2.00 (13.76) | -0.79 (13.20) | 0.420 | |
Passive Knee Extension (°) | 1.97 (5.44) | 2.93 (5.59) | 0.496 | 0.15 (4.59) | 0.34 (5.50) | 0.881 | |
Passive ROM (°) | -15.82 (19.28) | -20.79 (21.01) | 0.335 | 1.85 (15.31) | -1.14 (16.60) | 0.464 | |
TELE = telerehabalitation; FTF = face-to-face rehabilitation; IKDC = International Knee Documentation Committee Subjective Knee Form; LEFS: Lower Extremity Functional Scale; SF-12 = 12-item Short Form Survey; PCS = Physical Component Score; MCS = Mental Component Score; NPRS = Numeric Pain Rating Scale; ROM = Range of Motion. | |||||||
In terms of SF-12 scores, the PCS slightly decreased for the TELE group at 6 weeks but increased by 12 weeks, although the difference compared to the FTF group was not statistically significant (p = 0.291 at 12 weeks). The MCS remained stable, with no significant difference between groups at either time point. Pain, as measured by the Numeric Pain Rating Scale (NPRS), decreased similarly in both groups at 6 and 12 weeks, with p-values of 0.878 and 0.856, respectively, indicating no significant difference in pain reduction. Measures of knee flexion, extension, and range of motion (both active and passive) also showed no significant differences between the groups at either 6- or 12-week post-surgery (Table 2,3).
Similarly, the LEFS and SF-12 scores showed no statistically significant differences between groups, with p-values ranging from 0.144 to 0.983 for various outcomes. Knee flexion and extension measures also did not show significant differences at either time point, as indicated by the non-significant p-values across the range of motion (ROM) measures. Overall, the models suggest no significant differences in effectiveness between the TELE and FTF groups for any of the assessed outcomes at either 6- or 12-week post-surgery (Table 2,3).
Sensitivity analyses using ITT population with multiple imputation showed similar results in primary and secondary outcomes (see supplementary Tables 1 and 2).
Cost-effectiveness outcomes
The average total cost per patient over 12 weeks for the TELE group was significantly lower than for the FTF group. The total cost for the TELE group was 58,303.18 CNY compared to 82,358.90 CNY for the FTF group, with a p-value of less than 0.001, indicating a significant difference. The cost of physical therapy was a major contributor, with the TELE group incurring 6,980.00 CNY while the FTF group incurred 23,308.62 CNY, also with a significant p-value (< 0.001). Hospital stay costs were similar between the two groups (p = 0.903). Other medical costs, such as primary care, were substantially lower in the TELE group (163.64 CNY vs. 2,118.97 CNY, p < 0.001). However, non-medical costs, such as transportation, were also lower in the TELE group (711.52 CNY vs. 1,125.83 CNY, p = 0.009). Opportunity costs, including lost wages, were higher for the TELE group, although the differences were not statistically significant (Table 4).
Cost category (CNY) | TELE group (N = 33) | FTF group (N = 29) | P value |
|---|---|---|---|
Intervention cost | |||
Physical therapist cost | 6980.00 (0.00) | 23308.62 (1790.75) | < 0.001 |
Hospital stay cost | 5419.42 (1240.02) | 5381.69 (1187.83) | 0.903 |
Other medical cost | |||
Primary care | 163.64 (50.42) | 2118.97 (162.80) | < 0.001 |
Secondary care | 1133.70 (1017.21) | 1548.31 (1480.74) | 0.199 |
Paid home care | 192.70 (196.22) | 294.83 (290.16) | 0.106 |
Medication | 5216.06 (1074.05) | 5685.59 (1547.77) | 0.166 |
Non-medical cost | |||
Transportation cost | 711.52 (557.00) | 1125.83 (659.92) | 0.009 |
Nutrition cost | 1943.64 (660.84) | 1805.35 (619.35) | 0.401 |
Opportunity cost | |||
Lost wages for patients | 33459.79 (17910.55) | 39147.66 (20426.36) | 0.247 |
Lost wages for families | 3082.73 (3598.28) | 1942.07 (3249.20) | 0.198 |
TOTAL COST | 58303.18 (18408.65) | 82358.90 (21342.71) | < 0.001 |
TELE = telerehabalitation; FTF = face-to-face rehabilitation; CNY = Chinese Yuan | |||
The ICER analysis indicated that the TELE group was more cost-effective than the FTF group. At 12 weeks, the incremental cost for the TELE group was − 24,055.71 CNY, meaning a cost saving compared to the FTF group. However, the incremental effectiveness in terms of IKDC, LEFS, SF-12 PCS, SF-12 MCS, and active ROM was minimal and non-significant. The ICER for the IKDC score was − 158,767.64 CNY per point gained, indicating substantial cost savings per unit of effectiveness, but with no significant clinical difference. Other ICER values, such as for the LEFS, SF-12 PCS, and active ROM, also reflected cost savings, though the incremental improvements were small and not statistically significant (Table 5).
Incremental cost, CNY | Incremental IKDC score | Incremental LEFS score | Incremental SF-12 PCS | Incremental SF-12 MCS | Incremental Active ROM (°) | ICER (IKDC score) | ICER (LEFS score) | ICER (SF-12 PCS) | ICER (SF-12 MCS) | ICER (Active ROM) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
Per protocol, mixed effects, week 12 | -24055.71 (-34152.90, -13958.53) | 0.15 (-5.81, 6.11) | -1.71 (-6.99, 3.57) | -2.40 (-6.24, 1.44) | -0.06 (-5.60, 5.47) | 2.83 (-5.12, 10.78) | -158,767.64 | 14,063.11 | 10,033.22 | 394,520.18 | -8,498.09 |
ITT using multiple imputation, mixed effects, week 12 | -24055.71 (-34152.90, -13958.53) | 0.46 (-5.50, 6.43) | -2.78 (-7.99, 2.44) | -2.72 (-6.33, 0.90) | 1.10 (-4.25, 6.45) | 2.83 (-5.12, 10.78) | -51,736.59 | 8,664.15 | 8,859.65 | -21,861.61 | -8,498.09 |
| CNY = Chinese Yuan; IKDC = International Knee Documentation Committee Subjective Knee Form; LEFS: Lower Extremity Functional Scale; SF-12 = 12-item Short Form Survey; PCS = Physical Component Score; MCS = Mental Component Score; ROM = Range of Motion | |||||||||||
Adherence and acceptability
Adherence rates were high, the TELE group averaged 5.2 sessions per week, while the PT group averaged 5.1 sessions. Additionally, participants in both groups reported positive perceptions of the treatment received, with average scores of 8.7 out of 10 for all evaluated aspects, as documented in Table 6. There was no significant difference between groups with regard to positive perceptions of the treatment received (Table 6).
Outcome measure | TELE group (N = 33) | FTF group (N = 29) | P value |
|---|---|---|---|
Number of sessions performed per week, mean ± SD | 5.2 ± 1.1 | 5.1 ± 1.0 | 0.554 |
Agreement with the following questions (0 to 10)*, mean (SD) | |||
To what extent did you agree to accept the allocated exercise plan? | 8.3 ± 1.3 | 8.6 ± 1.2 | 0.094 |
To what extent did you do the exercise program as recommended? | 8.6 ± 1.4 | 8.7 ± 1.4 | 0.727 |
To what extent do you agree that the intervention relieved your pain? | 8.7 ± 1.4 | 8.8 ± 1.3 | 0.933 |
To what extent do you agree that the intervention improved your function? | 8.9 ± 1.2 | 9.0 ± 1.1 | 0.802 |
To what extent were you satisfied with the exercise protocol? | 9.5 ± 0.5 | 9.6 ± 0.5 | 0.805 |
| N/A, not applicable. | |||
| * 0 = strongly disagree, 10 = strongly agree. | |||
Adverse events
Throughout the follow-up period, the incidence of adverse events was comparable between the two groups. No serious events were linked to the telerehabilitation intervention, although one minor event was potentially associated with the FTF intervention (Table 7). The rates of participants lost to follow-up were also similar across both groups, with the majority of losses happening during the final follow-up survey (Fig. 1).
Adverse events | TELE group (N = 33) | PT group (N = 29) |
|---|---|---|
Patients with adverse events (no. [%]) | 5 (15.2) | 6 (20.7) |
Events related to study therapy (no.) | 0 | 1 |
Events unrelated to study therapy (no.) | 7 | 7 |
Type of event (no.) | ||
Involved knee | ||
Pain | 3 | 2 |
Swelling | 2 | 2 |
Muscle strain | 0 | 1# |
Signs of infection (swelling, redness, heat, or pus) | 0 | |
Mobilization under anesthesia | 0 | |
Other | ||
Nausea and dizziness | 0 | 1 |
Back pain | 0 | 1 |
Anxiety about knee recovery | 2 | 1 |
Serious adverse events* | ||
Patients with serious adverse events (no. [%]) | 0 | 0 |
Events related to study therapy (no.) | 0 | 0 |
Events unrelated to study therapy (no.) | 0 | 0 |
| #One patient sustained gastrocnemius muscle strain during intervention with minor consequent symptoms | ||
| *Patients with serious adverse events were automatically withdrawn from the study | ||
Discussion
This is the first study to examine the clinical and cost-effectiveness of telerehabilitation compared with hospital/clinical-based face-to-face rehabilitation for patients after arthroscopic ACL reconstruction in China. The mean treatment effect of the participants was assessed at week 6 and week 12 postoperatively. A significant difference was found for clinical effectiveness within the TELE and FTF groups from baseline to week 6 and week 12. More specifically, in this study, IKDC scores improved at week 12 in both the TELE and FTF groups, and there was no statistical difference in IKDC scores between the two groups. As an important knee kinematics score, IKDC scores can reflect the recovery of knee function after arthroscopic ACL reconstruction22; therefore, these findings indicate that tele-rehabilitation training can, like in-person physiotherapy, effectively restore joint function. The findings of this study are in line with the results of the study by Kosterink et al, who investigated the effects of a 4-week tele-treatment service in subjects with nonspecific neck and shoulder pain, where they showed that the treatment was effective in reducing pain intensity and disability over time23. A systematic review and meta-analysis comparing the effectiveness of home-based tele-rehabilitation with hospital-based rehabilitation programs found comparable long-term outcomes in pain, mobility, physical function, and patient-reported health status after primary total knee arthroplasty. This study suggests that tele-rehabilitation can be a viable alternative to hospital-based programs, considering the economic costs24. Zhao et al conducted a systematic review and meta-analysis to evaluate the effectiveness and safety of outpatient rehabilitation versus home-based rehabilitation after knee arthroplasty. The results of this study indicated no significant differences in knee flexion and extension between the home rehabilitation group and the outpatient rehabilitation group at various post-surgery intervals.
LEFS is designed to evaluate the functional abilities of patients with lower extremity disabilities by measuring the difficulty they experience in completing 20 daily activities, providing a comprehensive view of their functional status25–27. NPRS, which ranges from 0 (no pain) to 10 (worst imaginable pain), was employed in this study to assess patients' pain levels while walking28. Results in this study indicated that knee function improved in both groups, with no significant differences between them. Knee joint ROM is a key factor in postoperative recovery after arthroscopic ACL reconstruction, and the study found no significant differences in ROM (flexion and extension) between the groups, except for flexion at week 12, where the FTF group showed better results than the TELE group. Nevertheless, the majority of patients in both groups achieved knee flexion of 120° or more, and there were no statistically significant differences in the proportions of patients reaching the standard flexion range (0–120°). Thus, the analysis suggests that the TELE group is also effective in helping patients reach the 120° knee flexion goal by phase three of rehabilitation.
Previous research has indicated that mental health can deteriorate in patients with ACL injuries29. In this study, both groups showed substantial improvements in negative emotions related to ACL injuries and postoperative pain, as reflected in their improved SF-12 scores. By week 12, significant gains were observed in the MCS-12 and PCS-12 scores of both groups, though some PCS-12 scores remained above 50 (3/33 and 2/29). Despite guidance from physiotherapists, fully restoring pre-injury knee function by week 12 proved challenging for many, potentially contributing to the lower PCS-12 scores.
In line with the study conducted in Norway on patients with musculoskeletal problems, the results of this study indicated that telerehabilitation therapy was cost savin30. Also, it is understood that both cost and health benefits of the two interventions could have an impact on the cost-effectiveness of telerehabilitation. This study showed that telerehabilitation was less costly than face-to-face rehabilitation intervention. In line with our study, a cost analysis study in Canada, which was conducted on patients with a knee problem, also concluded that the cost of telerehabilitation was lower than that of conventional rehabilitation31. Other studies in the field of knee arthroplasty rehabilitation have also indicated the effectiveness of home-based rehabilitation programs. For instance, home exercise programs were found not to be inferior to outpatient physical therapy in terms of recovery of knee flexion after total knee arthroplasty. This finding further supports the potential of tele-rehabilitation as an effective alternative to traditional rehabilitation methods32. Additionally, a scoping review was conducted to evaluate the feasibility, cost-effectiveness, and access to quality rehabilitation services through tele-rehabilitation. The review highlighted the potential of tele-rehabilitation to change the standard of care, particularly in low to middle-income countries where healthcare provider distribution is scarce and uneven33.
The increment or reduction of the costs and effectiveness of the telerehabilitation by half from the base case values was unlikely to affect its cost-effectiveness in this study. The findings of this study are consistent with the results of the cost-effectiveness analysis study on telemedicine for primary care delivery, where telemedicine was shown to be cost saving as long as its effectiveness was greater than that of the controlled intervention30. However, the reduction of the health benefits from the base case values in this study could lead telerehabilitation not to be a cost-effective intervention. Overall, it is important that patients adhere to telerehabilitation services and improve their health for the new intervention to be cost-effective.
TELE was approximately 50% cheaper than FTF, this is because of less requirements of a hospital/clinic-based facility and less contact with a physiotherapist for its delivery. In other words, there is an opportunity to implement telerehabilitation programs across numerous geographic locations if needed. In middle-income countries, such as China, access to physiotherapy services is a challenge because of the shortage of physiotherapists and limited access to hospital/clinic -based programs34. Unlike FTF, TELE could overcome barriers to accessing physiotherapy services and could provide numerous benefits with reduced cost to the patients in China. However, the key challenges for its implementation strategies are the existence of effective internet services and patient reluctance to engage35.
The major strength of this study was that it is the first study in low- and middle-income countries to evaluate the cost-effectiveness of telerehabilitation therapy for patients after ACL reconstruction using a randomized controlled trial. In addition, the findings of this study could inform clinicians and decision makers about the implementation of TELE as a complementary option of FTF services in China. On the other hand, the findings reported here should be viewed in the context of the limitations of this study. The cost analysis did not include costs of medications and indirect costs. It is believed that the exclusion of costs of medications and indirect costs to the cost-effectiveness analysis may underestimate the total cost of therapies. The second limitation of the study was related to the time of follow-up; the effects of the telerehabilitation therapies might be different in the long-term follow-up. Thus, evidence of health benefits from a long-term follow-up of patients is important to be incorporated in the cost-effectiveness analysis of telerehabilitation.
In conclusion, the findings of this study showed that telerehabilitation was associated with greater health benefits and lower costs, suggesting that it was a cost-saving therapy compared with a hospital/clinic -based face-to-face rehabilitation. This suggests that the implementation of telerehabilitation could help to overcome barriers to access to physiotherapy services, particularly in middle-income countries such as China, thereby improving the health outcomes of patients in these countries. Future studies are required to assess the cost-effectiveness of the intervention in the long term from the patient and societal perspective.
Clinical messages
Findings
The study found that at the 12-week follow-up, there were no significant differences between telerehabilitation (TELE) and face-to-face rehabilitation (FTF) groups in terms of knee function, pain, or range of motion (ROM). The mean differences for various measurements (IKDC, LEFS, SF-12, NPRS, ROM) were close to zero. The average cost per person was significantly lower for the TELE group (58,303.18 CNY) compared to the FTF group (82,358.90 CNY), with the TELE intervention being more cost-effective.
Implications
This study demonstrates that telerehabilitation is non-inferior to traditional face-to-face rehabilitation for patients post-ACL reconstruction, providing similar clinical outcomes at a lower cost. The results suggest that telerehabilitation can be a viable alternative in settings where access to in-person rehabilitation is limited, potentially impacting clinical practice by offering a more accessible and cost-effective approach to rehabilitation.
Limitations
A key limitation of this study is its external validity; the results may not be generalizable to populations outside Shanghai, as the study was conducted at a single trauma center. The specific socio-economic and healthcare context in Shanghai may limit the applicability of these findings to other regions or healthcare systems.
A
Acknowledgement
The authors acknowledge the Shanghai Medmotion Clinic for providing the necessary equipment for the study.
A
Author Contribution
Conceptualization: S.L. and Y.H.Data curation: S.L. and C.Y.Formal analysis: C.X.Investigation: L.H. Y.H. and C.X.Methodology: S.L.Project administration: S.L. and Y.H.Writing – original draft: C.Y. and C.X.Writing – review and editing: S.L. and Y.H.
Data curation: S.L. and C.Y.
Formal analysis: C.X.
Investigation: Y.H. and C.X.
Methodology: S.L.
Project administration: S.L. and Y.H.
Supervision: L.H
Writing – original draft: C.Y. and C.X.
Writing – review and editing: S.L. and Y.H.
Declarations
Not applicable
Ethical considerations
The study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No: 2022-045-(1)) on May 26, 2022. All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.
Consent to participate
This study was conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent prior to enrollment. The consent form explained the purpose of the study, the procedures involved, any potential risks or discomforts, and the voluntary nature of participation.
Consent for publication
The authors have obtained written informed consent to publish but the written consent itself should be held by the authors themselves
Declaration
of conflicting interest
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article
A
Funding statement
I affirm that I have no financial affiliation (including research funding) or involvement with any commercial organization that has a direct financial interest in any matter included in this manuscript, except as disclosed and cited in the manuscript.
Data statement
Data is available upon request (contact the corresponding author after online publication).
All participants’ baseline characteristics as well as data obtained during follow-up period are available in blind format.
Name of the public trial registry: Chinese Clinical Trial Registry (https://www.chictr.org.cn/)
Trial registration number
ChiCTR2100053313
Electronic Supplementary Material
Below is the link to the electronic supplementary material
A
Data Availability
Data is available upon request (contact the corresponding author after online publication).All participants’ baseline characteristics as well as data obtained during follow-up period are available in blind format.
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