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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training
  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.
• Другое Traditional Rehabilitation Training
  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.
• Другое Prescribe home-based rehabilitation prescriptions for home rehabilitation training
  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).

Первичные конечные точки

• Constant-Murley Shoulder Assessment Scale(CMS) [Срок оценки: baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month]

Вторичные конечные точки (9)

• Visual Analogue Scale（VAS） [Срок оценки: Baseline，0 week，4 week，8 week，1 month ，2 month， 3 month]
• Active Range of Motion of the Shoulder-Forward Flexion [Срок оценки: Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months]
• Active Range of Motion of the Shoulder - Extension [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Active Range of Motion of the Shoulder - Adduction [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Active Range of Motion of the Shoulder - Abduction [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Active Range of Motion of the Shoulder - Internal Rotation [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Active Range of Motion of the Shoulder - External Rotation [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Shoulder Functional Movement Assessment - Quality Score [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]
• Shoulder Functional Movement Assessment - Completion Rate [Срок оценки: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07638761 · M20260381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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