Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Constant-Murley Shoulder Assessment Score Scale
Overview
Brief Summary
A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Experimental group
Combination of traditional rehabilitation and intelligent rehabilitation
Intervention: Artificial and intelligent combination of shoulder joint function exercise (Other)
Traditional rehabilitation group
Rehabilitation training by a rehabilitation therapist
Intervention: Traditional rehabilitation training (Other)
Smart rehabilitation group
Intervention: Intelligent rehabilitation training (Other)
Outcomes
Primary Outcomes
Constant-Murley Shoulder Assessment Score Scale
Time Frame: 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.
Secondary Outcomes
- 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)