AzTrials
AzTrials

ArticularNCT07638761

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

A study testing Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training, Traditional Rehabilitation Training and Prescribe home-based rehabilitation prescriptions for home rehabilitation training in people with Articular and Range of Motion, run by Peking University Third Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Articular, Range of Motion
What is being tested?
Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training, Traditional Rehabilitation Training and Prescribe home-based rehabilitation prescriptions for home rehabilitation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
14 Oct 2026to 14 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Peking University Third Hospital

    Beijing

    zhenlong Liu, 13261993917, zhenlong_liu@bjmu.edu.cn

Other trials in China

About this study

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).

Read the 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.

Being tested
Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training, Traditional Rehabilitation Training, Prescribe home-based rehabilitation prescriptions for home rehabilitation training
Keywords
Subacromial Impingement Syndrome, Artificial Intelligence, Digital Rehabilitation System
Medical subject headings
Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based Rehabilitation Training Combined with Intelligent Rehabilitation TrainingOther

    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 TrainingOther

    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 trainingOther

    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).

Study groups in NCT07638761
Study groupRoleWhat they receive
Traditional Rehabilitation GroupExperimentalPatients 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.
Receives: Other: Traditional Rehabilitation Training
AI-based Rehabilitation GroupExperimentalPatients 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.
Receives: Other: Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training
Control GroupExperimentalAfter diagnosis, patients in this arm receive only a home exercise prescription without additional active rehabilitation guidance or manual therapy.
Receives: Other: Prescribe home-based rehabilitation prescriptions for home rehabilitation training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start14 Oct 2026 (estimated)
  3. Primary completion14 Oct 2026 (estimated)
  4. Study completion14 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638761
Sponsor's protocol ID
M20260381
Status last verified
May 2026
First submitted
24 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Home-based Rehabilitation Training Combined with Intelligent Rehabilitation Training, Traditional Rehabilitation Training and Prescribe home-based rehabilitation prescriptions for home rehabilitation training in people with Articular and Range of Motion, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact zhenlong Liu (13261993917, zhenlong_liu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constant-Murley Shoulder Assessment Scale(CMS) (time frame: baseline, 4 weeks, 8 weeks ,1 month,2 month,3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in