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

9 juin 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

93

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Beijing, Chine
        • Peking University Third Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Expérimental: 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.
Autre: 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.
Expérimental: Control Group
After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
Autre: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Constant-Murley Shoulder Assessment Scale(CMS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Visual Analogue Scale（VAS）
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University Third Hospital

Les enquêteurs

  • Chercheur principal: zhenlong Liu, Peking University Third Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

14 octobre 2026

Achèvement primaire (Estimé)

14 octobre 2026

Achèvement de l'étude (Estimé)

14 octobre 2026

Dates d'inscription aux études

Première soumission

24 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • M20260381

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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