Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Constant-Murley Shoulder Assessment Score Scale
研究概览
简要总结
A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation
详细描述
Frozen Shoulder (FS), as a diffuse inflammatory disease, involves the glenohumeral joint, joint capsule, synovial tissues, and glenohumeral ligaments. Current management of FS includes conservative and surgical treatments. However, there remains room for improvement in the efficacy of conservative rehabilitation for FS. This study intends to enroll subjects diagnosed with Frozen Shoulder (FS) and conduct a randomized controlled trial to compare the safety and effectiveness of traditional rehabilitation versus remote intelligent rehabilitation for FS. Evaluations will include patient pain scores, shoulder joint function, and magnetic resonance imaging findings to observe the therapeutic effects of different interventions. This study aims to address how to enhance the rationality of FS patient management and identify the optimal rehabilitation treatment plan, thereby assisting FS patients in restoring daily living and motor functions as soon as possible.
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)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Subjects are aged between 40 and 60 years (inclusive), regardless of gender;
- •Diagnosed with the adhesive phase of frozen shoulder by the Department of Sports Medicine, with patients potentially coming from different physicians;
- •Have not participated in any other clinical trials within the past 3 months; ④ Patients voluntarily agree to participate in the clinical trial, sign the informed consent form, and are able to cooperate with clinical follow-up.
排除标准
- •① Patients with combined cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, coagulation disorders, severe electrocardiogram abnormalities, etc.;
- •Patients with local lesions in the affected shoulder or arm, such as skin damage, infection, tuberculosis, tumors, or skin diseases;
- •Patients with poor physical condition who are unable to tolerate the intensity of rehabilitation training; ④ Patients with cognitive impairments who cannot undergo normal rehabilitation training, or other conditions deemed by the physician as unsuitable for trial participation; ⑤ Pregnant or breastfeeding women; ⑥ Patients with other shoulder conditions, such as rotator cuff tears or shoulder dislocation.
研究组 & 干预措施
Experimental group
Combination of traditional rehabilitation and intelligent rehabilitation
干预措施: Artificial and intelligent combination of shoulder joint function exercise (Other)
Traditional rehabilitation group
Rehabilitation training by a rehabilitation therapist
干预措施: Traditional rehabilitation training (Other)
Smart rehabilitation group
干预措施: Intelligent rehabilitation training (Other)
结局指标
主要结局
Constant-Murley Shoulder Assessment Score Scale
时间窗: Week 0、Week 4 and Week 8
The Constant-Murley Shoulder Assessment Score Scale consists of four components: activities of daily living (20 points), pain (15 points), muscle strength (25 points), and range of motion (40 points), with a total score of 100 points. A lower score indicates a higher percentage of dysfunction, while a higher score indicates the opposite. The questionnaire demonstrates high accuracy and reliability and is commonly used to assess patients' shoulder joint conditions.
次要结局
- Visual Analogue Scale(Week 0、Week 4 and Week 8)
- Shoulder Range of Motion(Week 0、Week 4 and Week 8)
- Shoulder muscle strength(Week 0 、Week 4 and Week 8)
- Shoulder joint MRI(Week 0 、Week 4 and Week 8)
- Exercise completion rate(Week 0 、Week 4 and Week 8)