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NCT Number: NCT07638761

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

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).

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Key information

Conditions

Articular Joint Diseases Musculoskeletal Diseases Range of Motion Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training

Other

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.

Traditional rehabilitation training

Other

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.

Prescribe home-based rehabilitation prescriptions for home rehabilitation training

Other

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).

Primary outcomes

  1. Constant-Murley Shoulder Assessment Scale(CMS)

    Time frame: 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.

Secondary outcomes

  1. Visual Analogue Scale（VAS）

    Time frame: 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.

  2. Active Range of Motion of the Shoulder-Forward Flexion

    Time frame: 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.

  3. Active Range of Motion of the Shoulder - Extension

    Time frame: 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.

  4. Active Range of Motion of the Shoulder - Adduction

    Time frame: 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.

  5. Active Range of Motion of the Shoulder - Abduction

    Time frame: 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.

  6. Active Range of Motion of the Shoulder - Internal Rotation

    Time frame: 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.

  7. Active Range of Motion of the Shoulder - External Rotation

    Time frame: 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.

  8. Shoulder Functional Movement Assessment - Quality Score

    Time frame: 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.

  9. Shoulder Functional Movement Assessment - Completion Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

zhenlong Liu

CONTACT

[email protected]

13261993917

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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