- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638761
Efficacy Evaluation of Intelligent Rehabilitation Programs Based on AI-Powered Digital Rehabilitation System for Subacromial Impingement Syndrome
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zhenlong Liu
- 전화번호: 13261993917
- 이메일: zhenlong_liu@bjmu.edu.cn
연구 장소
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Beijing, 중국
- Peking University Third Hospital
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연락하다:
- Zhenlong Liu
- 전화번호: 13261993917
- 이메일: zhenlong_liu@bjmu.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:① Meet the diagnostic criteria for SIS (Subacromial Impingement Syndrome), i.e., 3 or more of the following 5 signs: tenderness on the anterior or lateral aspect of the acromion; positive Neer sign; positive Hawkins-Kennedy sign; positive painful arc test; positive external rotation resistance test;
MRI shows hyperintensity indicating subacromial bursitis;
Aged 18-60 years;
- Conscious, able to understand and cooperate with rehabilitation training, and willing to accept regular follow-up; ⑤ No shoulder surgery within the past 1 year, no other shoulder joint-related diseases, and no need for surgical intervention; ⑥ Voluntarily sign the informed consent form and commit to participating in the entire study.
Exclusion Criteria:① Concurrent shoulder dislocation, fracture, shoulder arthritis, calcific tendinitis, or other shoulder joint diseases;
History of shoulder surgery or current injury is an old tear (course >6 months without standardized treatment);
Suffering from severe cardiovascular or cerebrovascular diseases, diabetes, rheumatoid arthritis, osteoporosis, or other systemic diseases that may affect rehabilitation outcomes;
Cognitive impairment that prevents normal participation in rehabilitation training, or other conditions judged by the physician as making the patient unsuitable for the trial;
⑤ Participation in other rehabilitation intervention clinical trials within the past 1 month.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Traditional Rehabilitation Group
Patients receive in-clinic manual therapy (joint and soft tissue mobilization) twice weekly, plus daily home-based shoulder functional exercises (including ROM, flexibility, rotator cuff and scapular stabilizer strengthening) for 40 minutes per session, lasting 8 weeks.
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Patients receive in-clinic manual therapy (joint and soft tissue mobilization) twice weekly, plus daily home-based shoulder functional exercises (including ROM, flexibility, rotator cuff and scapular stabilizer strengthening) for 40 minutes per session, lasting 8 weeks.
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실험적: AI-based Rehabilitation Group
Patients receive in-clinic rehabilitation sessions twice weekly (same content as traditional group) and perform daily home training (40 minutes/day for 8 weeks) using the "ShuKangShi" AI digital rehabilitation system.
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Patients receive in-clinic rehabilitation sessions twice weekly (same content as traditional group) and perform daily home training (40 minutes/day for 8 weeks) using the "ShuKangShi" AI digital rehabilitation system.
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실험적: Control Group
After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
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After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
They perform prescribed home exercises on their own ,Only regular follow-up assessments are conducted (baseline, 4 weeks, 8 weeks, and 1, 2, 3 months post-intervention).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Constant-Murley Shoulder Assessment Scale(CMS)
기간: baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month
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he Constant-Murley Shoulder Score (CMS) is used to assess overall shoulder function.
As the gold-standard tool for rehabilitation evaluation of rotator cuff injuries, this scale integrates subjective and objective assessments, covering four dimensions: pain (15 points), activities of daily living (20 points), active range of motion (40 points), and muscle strength (25 points), with a total score of 100 points.
Scoring criteria: excellent for 80-100 points, good for 70-79 points, fair for 60-69 points, and poor for scores below 60 points.
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baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analogue Scale(VAS)
기간: Baseline,0 week,4 week,8 week,1 month ,2 month, 3 month
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The Visual Analogue Scale (VAS) is used to evaluate shoulder pain severity.
As a common tool for clinical pain assessment, it uses a 100-mm sliding scale with 0 points representing no pain at one end and 10 points representing the most severe pain at the other end.
Patients mark the corresponding position on the scale according to their pain perception; higher scores indicate more severe pain.
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Baseline,0 week,4 week,8 week,1 month ,2 month, 3 month
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Active Range of Motion of the Shoulder-Forward Flexion
기간: Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder forward flexion.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months
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Active Range of Motion of the Shoulder - Extension
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder extension.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Active Range of Motion of the Shoulder - Adduction
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder adduction.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Active Range of Motion of the Shoulder - Abduction
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder abduction.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Active Range of Motion of the Shoulder - Internal Rotation
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder internal rotation.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Active Range of Motion of the Shoulder - External Rotation
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Measured using a goniometer.
The patient actively performs shoulder external rotation.
The range of motion is measured in degrees (°).
A larger angle indicates better shoulder mobility.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Shoulder Functional Movement Assessment - Quality Score
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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The quality of shoulder-related functional movements is systematically observed and recorded, and scored according to predefined criteria.The unit is points , with higher scores indicating better movement quality.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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Shoulder Functional Movement Assessment - Completion Rate
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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The proportion of successfully completed shoulder-related functional movements is systematically observed and recorded.
The unit is percentage (%).
A higher completion rate indicates better shoulder functional performance.
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baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: zhenlong Liu, Peking University Third Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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