Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Joint range of motion
研究概览
简要总结
This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.
详细描述
In this randomized controlled clinical study, patients with unilateral rotator cuff tears were included. Starting from the fifth week after surgery, they were randomly assigned to either an online wearable device training group or an offline traditional rehabilitation group, with analyses conducted through functional tests and assessments. The study investigated the impact of wearable device rehabilitation on functional recovery in patients with rotator cuff tears and compared it with offline traditional rehabilitation to verify its efficacy.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •First-time rotator cuff injury surgery and received surgical treatment at Peking University Third Hospital;
- •MRI shows a tear with a maximum diameter <3 cm, confirmed by at least three musculoskeletal rehabilitation radiologists;
- •Possess a mobile device with internet access (e.g., smartphone or tablet) capable of using mobile applications;
- •Able to complete the planned study and follow-ups within 6 months after discharge;
- •No visual, hearing, cognitive, or communication impairments;
- •Able to provide informed and valid consent to participate in the study.
排除标准
- •Presence of serious cardiovascular or cerebrovascular diseases, or cervical spondylosis with nerve damage;
- •Presence of cognitive impairment or vision problems;
- •Stroke, rheumatic disease, neurological disorders, or diseases limiting overall physical function or cardiopulmonary function within the past 2 years;
- •No prior history of shoulder joint injury, and having undergone other surgeries within the past 6 months;
- •Patients who cannot complete the entire cycle or drop out midway;
- •Presence of serious postoperative complications, such as wound infection, venous thromboembolism, etc.
研究组 & 干预措施
Online Wearable Device Training Group
The online wearable device training group trained independently using wearable sensor devices according to the 'Fugu Medical Mini Program' instructions. Training started from the 5th week post-surgery and continued until the 12th week, totaling 8 weeks, with a minimum of 3 training days per week and 50 minutes each day.
干预措施: Wearable device rehabilitation (Device)
Offline Traditional Rehabilitation Group
The offline traditional rehabilitation group carries out rehabilitation training under the guidance of therapists. Starting from the 5th week post-surgery and continuing until the 12th week, the training lasts for a total of 8 weeks, with at least 3 sessions per week, each lasting 50 minutes.
干预措施: Offline Traditional Rehabilitation (Other)
结局指标
主要结局
Joint range of motion
时间窗: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
Use a goniometer to measure the subject's shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation exercises to test the range of motion of the shoulder in each direction, with the unit in degrees (°).
Upper Limb Closed-Chain Stability Test
时间窗: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
For the starting position, male subjects perform a standard push-up, while female subjects perform a knee push-up, keeping their back flat. The distance between the hands is 36 inches. One hand remains in support while the other hand swings to touch the supporting hand and then returns to the starting position. Then switch the supporting hand and repeat the movement. One repetition is counted when the swinging hand leaves the ground, touches the supporting hand, and returns to the starting position. Record the number of full-effort hand touches completed by the subject within 15 seconds, and repeat the test 3 times.
FMS Shoulder Mobility Test
时间窗: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
The subjects were asked to make fists with both hands, placing their thumbs inside the fists. Then, the subjects were required to position one shoulder in maximum adduction, extension, and internal rotation, while the other shoulder was in maximum abduction, flexion, and external rotation, and both hands needed to be placed on the back in a smooth movement. Throughout the process, both hands remained clenched in fists. The tester measured the distance between the two closest bony prominences of the hands on the back. The test was repeated three times.
Isometric Strength Test
时间窗: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
The subjects performed shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation movements, resisting resistance to perform isometric contractions, and their muscle strength was measured.
Surface electromyography
时间窗: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.
Using the Delsys surface electromyography (EMG) test device to measure the surface EMG signals of shoulder muscles such as the anterior, middle, and posterior deltoid, serratus anterior, upper, middle, and lower trapezius, and supraspinatus during maximal voluntary contraction tests, with the unit of measurement being '%BW'.
次要结局
- Constant- Murley score(Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative)
- American Shoulder and Elbow Surgeon's Form(Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative)
- Western Ontario Rotator Cuff Index(Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative)