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NCT Number: NCT07549867

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

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.

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Key information

Conditions

Discoid Meniscus of Knee

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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°.

  7. 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.

  8. 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

  9. 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).

Secondary outcomes

  1. 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.

  2. 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 (%).

  3. 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 (%).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Deng

CONTACT

[email protected]

+86 134-3807-6366

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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