Articular, Range of Motion
Conditions
Keywords
Subacromial Impingement Syndrome, Artificial Intelligence, Digital Rehabilitation System
Brief summary
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).
Detailed description
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.
Interventions
OTHERHome-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.
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.
OTHERPrescribe 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).
Sponsors
Peking University Third Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Shoulder Assessment Scale(CMS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale（VAS） | 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. |
| Active Range of Motion of the Shoulder-Forward Flexion | 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. |
| Active Range of Motion of the Shoulder - Extension | 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. |
| Active Range of Motion of the Shoulder - Adduction | 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. |
| Active Range of Motion of the Shoulder - Abduction | 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. |
| Active Range of Motion of the Shoulder - Internal Rotation | 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. |
| Active Range of Motion of the Shoulder - External Rotation | 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. |
| Shoulder Functional Movement Assessment - Quality Score | 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. |
| Shoulder Functional Movement Assessment - Completion Rate | 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. |
Countries
China
Contacts
CONTACTzhenlong Liu
PRINCIPAL_INVESTIGATORzhenlong Liu
Peking University Third Hospital
Outcome results
None listed