Wearable intelligent rehabilitation for frozen shoulder
Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder
This trial will try a wearable smart-rehab program to see if it reduces pain and improves shoulder motion for adults aged 40–60 with adhesive-phase frozen shoulder compared with traditional rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07422714 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll patients aged 40–60 diagnosed with the adhesive phase of frozen shoulder and compare traditional in-person rehabilitation to a remote intelligent rehabilitation program guided by a wearable device. Participants will be randomly assigned to receive standard functional shoulder exercises or an artificial-intelligence–assisted remote exercise program with wearable monitoring. Outcomes include patient-reported pain scores, shoulder joint function measures, and magnetic resonance imaging to observe structural changes and safety. The trial aims to determine whether the wearable-supported remote intervention can improve recovery speed, function, and management rationality compared with usual care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–60 with a clinical diagnosis of adhesive-phase frozen shoulder who can follow rehabilitation guidance, consent to the protocol, and attend required visits at the study center.
Not a fit: Patients with serious cardiovascular, cerebrovascular, liver or kidney disease, coagulation disorders, severe ECG abnormalities, active local shoulder infections or skin lesions, cognitive impairment, or those unable to tolerate rehabilitation intensity are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the wearable-supported remote program could help patients regain shoulder motion faster and with better pain control while allowing more guided home-based rehabilitation.
How similar studies have performed: Similar tele-rehabilitation and wearable-supported programs for shoulder conditions have shown promising and sometimes non-inferior results in prior studies, but there are relatively few large trials focused specifically on adhesive frozen shoulder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:① Subjects are aged between 40 and 60 years (inclusive), regardless of gender; * Diagnosed with the adhesive phase of frozen shoulder by the Department of Sports Medicine, with patients potentially coming from different physicians; * Have not participated in any other clinical trials within the past 3 months; ④ Patients voluntarily agree to participate in the clinical trial, sign the informed consent form, and are able to cooperate with clinical follow-up. Exclusion Criteria:① Patients with combined cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, coagulation disorders, severe electrocardiogram abnormalities, etc.; * Patients with local lesions in the affected shoulder or arm, such as skin damage, infection, tuberculosis, tumors, or skin diseases; * Patients with poor physical condition who are unable to tolerate the intensity of rehabilitation training; ④ Patients with cognitive impairments who cannot undergo normal rehabilitation training, or other conditions deemed by the physician as unsuitable for trial participation; ⑤ Pregnant or breastfeeding women; ⑥ Patients with other shoulder conditions, such as rotator cuff tears or shoulder dislocation.
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhenlong Liu
- Email: zhenlong_liu@bjmu.edu.cn
- Phone: 13261993917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.