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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University Third Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training

    Other intervention

    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 intervention

    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 intervention

    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).

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Traditional Rehabilitation GroupExperimental treatment 1 intervention
Group B: AI-based Rehabilitation GroupExperimental treatment 1 intervention
Group C: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Constant-Murley Shoulder Assessment Scale(CMS)

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.

Time frame
baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month

Secondary outcomes

1

Visual Analogue Scale(VAS)

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.

Time frame
Baseline,0 week,4 week,8 week,1 month ,2 month, 3 month
2

Active Range of Motion of the Shoulder-Forward Flexion

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.

Time frame
Baseline, Week 0, Week 4, Week 8, 1 month, 2 months, 3 months
3

Active Range of Motion of the Shoulder - Extension

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.

Time frame
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
4

Active Range of Motion of the Shoulder - Adduction

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.

Time frame
baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months

Other outcomes

Sponsors and contacts

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