Comparison of the Efficacy of Telerehabilitation and In-person Rehabilitation Based on Wearable Devices After ACLR Surgery: a Multicenter Randomized Controlled Trial

Purpose: Investigate whether telerehabilitation based on wearable devices is clinically as effective as in-person rehabilitation for ACLR patients.

Subjects: 164 patients aged ≥18 years who underwent ACLR. Design: A mixed-block randomization method was used to randomly assign participants to two groups: the telerehabilitation group and the in-person rehabilitation group, with a 50% probability of assignment to each group. All participants received standard postoperative rehabilitation training with identical content. The telerehabilitation group received postoperative telerehabilitation guidance via software and sensors. The in-person rehabilitation group received therapist-administered treatment with three rehabilitation sessions per week. All participants underwent regular follow-ups (1 day preoperatively, 3 months postoperatively, and 6 months postoperatively).

Primary outcome measure: The primary outcome measure was the Lysholm score. Secondary outcome measures included the IKDC score, Tegner Activity Scale, SF-36 questionnaire, VAS score, and isokinetic muscle strength of the knee joint.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Other: in-person rehabilitation; Other: telerehabilitation

Detailed Description

Purpose: Investigate whether telerehabilitation based on wearable devices is clinically as effective as in-person rehabilitation for ACLR patients.

Subjects: Participants: This study recruited 164 participants (aged ≥18 years) undergoing ACLRsurgery;

Inclusion criteria:

(1) Age range 18-60 years; (2) First-time unilateral ACLR surgery or ACLR combined with meniscus resection surgery; (3) No other lower limb joint injuries at the same time; (4) Possession of an internet-connected mobile device capable of using a mobile application; (5) Alert and oriented, with no communication impairments; Exclusion Criteria: (1) Patients undergoing revision surgery; (2) Patients who have previously undergone other lower limb surgeries; (3) Patients scheduled for another lower limb surgery within the next 6 months; (4) Patients with concomitant knee ligament injuries or severe structural damage beyond meniscal tears; (5) Patients with other comorbidities that may interfere with rehabilitation exercises; (6) Patients undergoing acute-phase surgery; (7)Patients undergoing acute surgery.

Protocol: Participants were randomly assigned to two groups using a mixed-block randomization method: the telerehabilitation group and the in-person rehabilitation group. The allocation probability for both groups was 50%. All participants received routine outpatient diagnosis and treatment. Postoperative rehabilitation training used a standardized postoperative rehabilitation training protocol with identical content. The telerehabilitation group received postoperative telerehabilitation guidance via software and sensors. The in-person rehabilitation group received three face-to-face rehabilitation sessions per week. All participants underwent regular follow-ups (1 day preoperatively, 3 months postoperatively, and 6 months postoperatively).

Primary outcome measure: The primary outcome measure was the Lysholm score. Secondary outcome measures included the IKDC score, Tegner Activity Scale, SF-36 questionnaire, VAS score, isokinetic muscle strength of the knee joint, and muscle strength symmetry.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • quan Jian Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(1) Age range 18-60 years; (2) First-time unilateral ACLR surgery or ACLR combined with meniscus resection surgery; (3) No other lower limb joint injuries at the same time; (4) Possession of an internet-connected mobile device capable of using a mobile application; (5) Alert and oriented, with no communication impairments;

Exclusion Criteria:

(1) Patients undergoing revision surgery; (2) Patients who have previously undergone other lower limb surgeries; (3) Patients scheduled for another lower limb surgery within the next 6 months; (4) Patients with concomitant knee ligament injuries or severe structural damage beyond meniscal tears; (5) Patients with other comorbidities that may interfere with rehabilitation exercises; (6) Patients undergoing acute-phase surgery; (7)Patients undergoing acute surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: in-person rehabilitation group; The in-person rehabilitation group takes a face-to-face approach, with therapists providing outpatient rehabilitation instruction twice a week for six weeks.	Other: in-person rehabilitation; The in-person rehabilitation group uses a face-to-face approach, with therapists providing outpatient rehabilitation guidance to patients three times a week for six weeks. After that, patients exercise at home according to the rehabilitation manual.
Experimental: telerehabilitation group; The telerehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance.	Other: telerehabilitation; The telerehabilitation group uses smart wearables and mobile apps worn around the knee joint to perform telerehabilitation at home. Both sets of training sessions are identical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm score	Used to assess knee joint function, with a score range of 0-100, where a higher score indicates better knee joint function.	From before ACLR surgery to 6 months post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC score	Used to assess knee joint function, with a score range of 0-100. The higher the score, the better the knee joint function.	From before ACLR surgery to 6 months post-surgery.
Tegner score	Used to assess motor function. The range is 0-10, with higher scores indicating better knee function.	From before ACLR surgery to 6 months post-surgery.
VAS score	Used to assess pain levels. The range is 0-10, with higher scores indicating higher pain levels.	From before ACLR surgery to 6 months after surgery.
Short Form-36 Health Survey(SF-36)	Used to assess quality of life. There are 9 subscales, each with a score range of 0-100, with higher scores indicating better knee function.	From before ACLR surgery to 6 months post-surgery.
Peak torque and symmetry of knee flexors and extensors	Used to assess knee muscle strength	From before ACLR surgery to 6 months after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale	Anterior Cruciate Ligament Return to Sport After Injury Scale	six months after ACL reconstruction
VAS pain score	VAS pain score	six months after ACL reconstruction

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital
• Investigators: Study Chair: quan J Wang, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Telerehabilitation; ACLR
• Other Study ID Numbers: M2023132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No