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

NCT06327555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-08-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • quan J Wang, M.D. · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-30
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327555 on ClinicalTrials.gov