NCT07638761

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 14, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2026

Last Updated

June 10, 2026

Status Verified

May 1, 2026

Enrollment Period

Same day

First QC Date

May 24, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Subacromial Impingement SyndromeArtificial IntelligenceDigital Rehabilitation System

Outcome Measures

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.

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

Secondary Outcomes (9)

  • Visual Analogue Scale(VAS)

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

  • Active Range of Motion of the Shoulder-Forward Flexion

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

  • Active Range of Motion of the Shoulder - Extension

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

  • Active Range of Motion of the Shoulder - Adduction

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

  • Active Range of Motion of the Shoulder - Abduction

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

  • +4 more secondary outcomes

Study Arms (3)

Traditional Rehabilitation Group

EXPERIMENTAL

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.

Other: Traditional Rehabilitation Training

AI-based Rehabilitation Group

EXPERIMENTAL

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.

Other: Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training

Control Group

EXPERIMENTAL

After diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.

Other: Prescribe home-based rehabilitation prescriptions for home rehabilitation training

Interventions

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.

AI-based 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.

Traditional Rehabilitation Group

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).

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • zhenlong Liu

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 10, 2026

Study Start (Estimated)

October 14, 2026

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2026

Last Updated

June 10, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations