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

9 de junio de 2026 actualizado por: 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).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

93

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Peking University Third Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.
Experimental: 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.
Otro: 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.
Experimental: Control Group
After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
Otro: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Constant-Murley Shoulder Assessment Scale(CMS)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Analogue Scale（VAS）
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Peking University Third Hospital

Investigadores

  • Investigador principal: zhenlong Liu, Peking University Third Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

14 de octubre de 2026

Finalización primaria (Estimado)

14 de octubre de 2026

Finalización del estudio (Estimado)

14 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M20260381

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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