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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
93
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.
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.
Peking University Third Hospital
Beijing, China
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
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
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
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
Active Range of Motion of the Shoulder - Adduction
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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).
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
Active Range of Motion of the Shoulder - Abduction
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.
Time frame: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - Internal Rotation
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.
Time frame: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Active Range of Motion of the Shoulder - External Rotation
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.
Time frame: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Shoulder Functional Movement Assessment - Quality Score
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.
Time frame: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months
Shoulder Functional Movement Assessment - Completion Rate
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.
Time frame: baseline, 0 week, 4 weeks, 8 weeks, 1 month, 2 months, 3 months