Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus

NCT07549867 | Not Yet Recruiting DMC

• 1 other identifier: 2026（399）
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed as a single-center, prospective, randomized controlled trial. The aim of this clinical trial is to evaluate the effectiveness, safety, and feasibility of a wearable device-based telerehabilitation approach for postoperative recovery in patients undergoing arthroscopic surgery for discoid meniscus injury. The core research questions to be addressed are: to compare the effects of two postoperative rehabilitation methods (clinic rehabilitation versus telerehabilitation) on knee function scores in patients after arthroscopic discoid meniscus surgery; and to compare patient satisfaction, rehabilitation adherence, and clinical benefit between the two postoperative rehabilitation interventions. Participants will be randomly assigned to either the clinic rehabilitation group or the telerehabilitation group. The telerehabilitation group will undergo digital rehabilitation using wearable devices and a telerehabilitation system postoperatively, while the clinic rehabilitation group will receive one-on-one exercise rehabilitation sessions in an outpatient setting. Both groups will be followed up for six months postoperatively, with assessments scheduled at multiple time points: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively. The primary outcome measures focus on clinical functional improvement, including range of motion (ROM), weight-bearing progression, muscle strength, swelling, limb circumference, functional scores (Visual Analog Scale \[VAS\] for pain, Tegner activity scale, International Knee Documentation Committee \[IKDC\] subjective form, Lysholm knee score, Ikeuchi meniscus postoperative functional score), three-dimensional gait analysis parameters, and return-to-sports evaluation. Secondary outcomes include patient satisfaction, rehabilitation adherence, imaging findings, and complication assessment.

Conditions

Discoid Meniscus of Knee

Keywords

telerehabilitation; wearable device; discoid meniscus

Outcome Measures

Primary Outcomes (9)

• Lysholm knee scoring scale

  The full name of the scale is the Lysholm Knee Scoring Scale. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Visual Analog Scale

  The full name of the scale is Visual Analog Scale. The minimum possible score is 0, and the maximum is 10, with higher scores indicating worse outcomes.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• IKDC Subjective Knee Evaluation Form

  The full name of the scale is IKDC Subjective Knee Evaluation Form. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Tegner score

  The full name of the scale is Tegner score The minimum possible score is 0, and the maximum is 10, with higher scores indicating better outcomes.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Three-dimensional gait analysis

  Three-dimensional gait analysis will use an infrared three-dimensional motion capture system to assess patient gait parameters, including step length (in meters), gait speed (in meters per second), gait cycle (in seconds), and other metrics.

  preoperatively, and at 24 weeks postoperatively.

• Knee range of motion

  Knee range of motion refers to the measured angles of knee flexion and extension, expressed in degrees. The measurement method is as follows: using the lateral femoral epicondyle as the axis, the angle between the longitudinal axis of the femur and the long axis of the fibula is measured. The normal range is 0° to 150°.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Limb Circumference

  Limb circumference refers to the measurement of the cross-sectional dimension of the thigh, expressed in centimeters. The cross-sectional dimensions of the limb will be measured at 5 cm, 10 cm, and 15 cm proximal to the superior border of the patella.

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Muscle Strength

  Muscle strength refers to the measurement of muscle strength using an isokinetic dynamometer, yielding the peak torque of the quadriceps and hamstring muscles, expressed in Nm/kg

  preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.

• Return to Sport Assessment

  Return-to-sport assessment refers to the decision-making process that systematically evaluates the readiness for safe return to sport using a multi-dimensional indicator system. This assessment includes the VAS score, muscle strength test results, single-leg hop test results (testing method: bilateral single-leg hops are performed separately, the hop distance is recorded in centimeters, and the interlimb difference is calculated as a percentage), and the Y-balance test (testing method: anterior, posteromedial, and posterolateral reaches are performed bilaterally, the foot displacement is recorded in centimeters, and both interlimb difference and symmetry index are calculated as percentages).

  at 24 weeks postoperatively

Secondary Outcomes (4)

• MRI

  preoperatively and at 24 weeks postoperatively.

• Patient Satisfaction Questionnaire

  at 24 weeks postoperatively

• Rehabilitation Adherence

  From preoperatively to 24 weeks postoperatively

• X-ray

  preoperatively and at 24 weeks postoperatively.

Study Arms (2)

Clinic rehabilitation group

ACTIVE COMPARATOR

Postoperatively, patients received systematic on-site rehabilitation guidance from a therapist and were permitted to continue rehabilitation at home independently only after mastering the essential techniques of the prescribed exercises.

Other: Clinic rehabilitation

Telerehabilitation group

EXPERIMENTAL

Postoperatively, patients underwent systematic telerehabilitation training assisted by smart wearable devices.

Other: Telerehabilitation intervention based on wearable devices

Interventions

Telerehabilitation intervention based on wearable devices OTHER

This model integrated 5G network connectivity, mobile terminal applications, and wearable devices, enabling patients to perform rehabilitation exercises under real-time video and audio guidance. Patients underwent systematic telerehabilitation training assisted by wearable devices, following the same rehabilitation protocol as the on-site rehabilitation group. The patients installed the software on their smartphones and received a 24-week daily exercise program through the software platform. The rehabilitation training content for each phase was developed by a therapist on the software backend and then delivered to the patient via the application.

Telerehabilitation group

Clinic rehabilitation OTHER

Patients in the on-site rehabilitation group attended outpatient follow-up visits at 2, 6, 12, and 24 weeks postoperatively. During these visits, they received one-on-one, face-to-face systematic exercise rehabilitation training and guidance from a uniformly trained rehabilitation therapist, with at least one session per time point, each lasting 40 minutes. After mastering the essential techniques of the prescribed exercises, patients continued rehabilitation at home independently according to the established protocol.

Clinic rehabilitation group

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 10 and 60 years.
• Diagnosed with a discoid meniscus injury, confirmed by both magnetic resonance imaging (MRI) and arthroscopy.
• Underwent arthroscopic partial meniscectomy (saucerization) with concomitant suture repair.
• Willing to participate in the clinical trial and comply with the follow-up protocol.

You may not qualify if:

• Presence of concomitant injuries in the same knee, such as ligament tears, fractures, or cartilage lesions.
• Kellgren \& Lawrence osteoarthritis grade greater than II.
• History of trauma or surgery in other weight-bearing joints of the lower limb (e.g., ankle ligament tears, osteonecrosis of the femoral head) that could indirectly affect knee joint loading and movement.

Sponsors & Collaborators

• West China Hospital: lead

Central Study Contacts

Qian Deng

CONTACT

+86 134-3807-6366; dengqianre@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given that blinding participants and personnel to the intervention is not feasible in this study, the following measures were implemented to minimize potential bias. All study personnel will receive standardized training to ensure consistent delivery of the interventions and assessment procedures. The randomization sequence will be generated and managed by an independent statistician who is not involved in the subsequent data analysis or the core research team, thereby preventing selection bias. Furthermore, data collectors and outcome assessors will be blinded to group allocation throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation therapist

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04