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

April 18, 2026 updated by: Deng Qian, West China Hospital

Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus: A Prospective, Randomized Controlled Trial Protocol

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1.Presence of concomitant injuries in the same knee, such as ligament tears, fractures, or cartilage lesions.
  • 2.Kellgren & Lawrence osteoarthritis grade greater than II.
  • 3.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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Clinic rehabilitation group
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
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.
Experimental: Telerehabilitation group
Postoperatively, patients underwent systematic telerehabilitation training assisted by smart wearable devices.
Other: Telerehabilitation intervention based on wearable devices
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lysholm knee scoring scale
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
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
Time Frame: at 24 weeks postoperatively
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: preoperatively and at 24 weeks postoperatively.
MRI will utilize T1-weighted and T2-weighted images in the axial, coronal, and sagittal planes to describe the degree of injury and healing of the discoid meniscus, the extent of articular cartilage damage, etc.
preoperatively and at 24 weeks postoperatively.
Patient Satisfaction Questionnaire
Time Frame: at 24 weeks postoperatively
Patient satisfaction questionnaire: Using a questionnaire format, patients report whether they are satisfied with their current overall recovery status. The proportion of patients selecting 'very satisfied' is then calculated and expressed as a percentage (%).
at 24 weeks postoperatively
Rehabilitation Adherence
Time Frame: From preoperatively to 24 weeks postoperatively
Rehabilitation adherence will be calculated as the exercise completion rate recorded by the remote rehabilitation platform and the patient self-reported exercise completion rate, expressed as a percentage (%).
From preoperatively to 24 weeks postoperatively
X-ray
Time Frame: preoperatively and at 24 weeks postoperatively.
X-rays will be taken of the patient's knee joint in anteroposterior and lateral views, and the findings will describe whether the femur and tibia are fixed in proper alignment, the severity of knee osteoarthritis, etc.
preoperatively and at 24 weeks postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026（399）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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