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

NCT06327555 | Completed DMC

• 1 other identifier: M2023132
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACLR; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• IKDC score

  From before ACLR surgery to 6 months post-surgery.

• Tegner score

  From before ACLR surgery to 6 months post-surgery.

• VAS score

  From before ACLR surgery to 6 months after surgery.

• Short Form-36 Health Survey(SF-36)

  From before ACLR surgery to 6 months post-surgery.

• Peak torque and symmetry of knee flexors and extensors

  From before ACLR surgery to 6 months after surgery.

Study Arms (2)

in-person rehabilitation group

OTHER

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

telerehabilitation group

EXPERIMENTAL

The telerehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance.

Other: telerehabilitation

Interventions

telerehabilitation OTHER

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.

telerehabilitation group

in-person rehabilitation OTHER

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.

in-person rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Peking University First Hospital: collaborator

Study Sites (1)

quan Jian Wang

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• quan J Wang, M.D.

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 25, 2024
• Study Start: March 30, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)