이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Efficacy Evaluation of Intelligent Rehabilitation Programs Based on AI-Powered Digital Rehabilitation System for Subacromial Impingement Syndrome

2026년 6월 9일 업데이트: Peking University Third Hospital
This non-randomized controlled trial will compare the efficacy of a conventional rehabilitation program versus an AI-based digital rehabilitation system in patients with subacromial impingement syndrome (SIS).

연구 개요

상세 설명

Subacromial impingement syndrome is a common cause of shoulder pain. Although exercise therapy is effective, clinical outcomes remain suboptimal. An AI-based digital rehabilitation system can monitor patients' home exercise movements in real time and provide feedback. This study will enroll 93 patients with SIS, who will be allocated by preference into three groups: control (home exercise prescription only), traditional rehabilitation (manual therapy + daily home exercises for 8 weeks), and AI-based rehabilitation (in-clinic sessions + AI-powered home training with remote supervision for 8 weeks). The primary outcome is CMS; secondary outcomes include VAS, active shoulder range of motion, and functional movement assessment. Follow-up occurs at baseline, 4 weeks, 8 weeks, and 1, 2, and 3 months post-intervention.

연구 유형

중재적

등록 (추정된)

93

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
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.
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.
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.
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.
실험적: Control Group
After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Constant-Murley Shoulder Assessment Scale(CMS)
기간: baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month
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.
baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month

2차 결과 측정

결과 측정
측정값 설명
기간
Visual Analogue Scale(VAS)
기간: Baseline,0 week,4 week,8 week,1 month ,2 month, 3 month
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.
Baseline,0 week,4 week,8 week,1 month ,2 month, 3 month
Active Range of Motion of the Shoulder-Forward Flexion
기간: Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months
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.
Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - Extension
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - Adduction
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - Abduction
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - Internal Rotation
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - External Rotation
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Shoulder Functional Movement Assessment - Quality Score
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Shoulder Functional Movement Assessment - Completion Rate
기간: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
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.
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: zhenlong Liu, Peking University Third Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 14일

기본 완료 (추정된)

2026년 10월 14일

연구 완료 (추정된)

2026년 10월 14일

연구 등록 날짜

최초 제출

2026년 5월 24일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다