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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-60
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telerehabilitation intervention based on wearable devices

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Clinic rehabilitation groupActive comparator 1 intervention
Group B: Telerehabilitation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
3

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.

Time frame
preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
4

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.

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

Secondary outcomes

1

MRI

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.

Time frame
preoperatively and at 24 weeks postoperatively.
2

Patient Satisfaction Questionnaire

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 (%).

Time frame
at 24 weeks postoperatively
3

Rehabilitation Adherence

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 (%).

Time frame
From preoperatively to 24 weeks postoperatively
4

X-ray

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.

Time frame
preoperatively and at 24 weeks postoperatively.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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