Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus: A Prospective, Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Lysholm knee scoring scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Clinic rehabilitation (Other)
Telerehabilitation group
Postoperatively, patients underwent systematic telerehabilitation training assisted by smart wearable devices.
干预措施: Telerehabilitation intervention based on wearable devices (Other)
结局指标
主要结局
Lysholm knee scoring scale
时间窗: 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.
Visual Analog Scale
时间窗: 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.
IKDC Subjective Knee Evaluation Form
时间窗: 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.
Tegner score
时间窗: 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.
Three-dimensional gait analysis
时间窗: 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.
Knee range of motion
时间窗: 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°.
Limb Circumference
时间窗: 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.
Muscle Strength
时间窗: 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
Return to Sport Assessment
时间窗: 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).
次要结局
- 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.)
研究者
Deng Qian
Rehabilitation therapist
West China Hospital