Wearable-guided home rehabilitation after rotator cuff repair

Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury

This tests whether a wearable-device remote rehabilitation program helps adults recovering from small-to-medium rotator cuff surgery regain shoulder function better than traditional in-person rehab.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07412184 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial at Peking University Third Hospital enrolled adults who had their first unilateral rotator cuff repair with MRI-confirmed tears under 3 cm. Beginning five weeks after surgery, participants were randomized to either an online wearable-device rehabilitation program or to offline traditional outpatient rehabilitation, with 36 patients in each arm. Functional recovery was measured using standardized physical tests and patient-reported outcomes with follow-up visits up to six months. Participants needed a compatible smartphone or tablet and the ability to complete planned remote sessions and clinic follow-ups.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) who had a first-time unilateral rotator cuff repair with a tear <3 cm, can use a smartphone or tablet, and can attend follow-ups at Peking University Third Hospital.

Not a fit: Patients with large or recurrent tears, significant cardiovascular, neurological, cognitive, or sensory impairments, or those without smartphone/internet access or unable to attend follow-ups are unlikely to benefit.

Why it matters

Potential benefit: If successful, the wearable program could allow patients to complete effective rehabilitation at home, improving convenience and access while maintaining or improving shoulder recovery.

How similar studies have performed: Previous trials of tele-rehabilitation and wearable sensor-guided exercises for shoulder conditions have shown promising but mixed results, so this randomized trial adds needed evidence.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* First-time rotator cuff injury surgery and received surgical treatment at Peking University Third Hospital;
* MRI shows a tear with a maximum diameter \<3 cm, confirmed by at least three musculoskeletal rehabilitation radiologists;
* Possess a mobile device with internet access (e.g., smartphone or tablet) capable of using mobile applications;
* Able to complete the planned study and follow-ups within 6 months after discharge;
* No visual, hearing, cognitive, or communication impairments;
* Able to provide informed and valid consent to participate in the study.

Exclusion Criteria:

* Presence of serious cardiovascular or cerebrovascular diseases, or cervical spondylosis with nerve damage;
* Presence of cognitive impairment or vision problems;
* Stroke, rheumatic disease, neurological disorders, or diseases limiting overall physical function or cardiopulmonary function within the past 2 years;
* No prior history of shoulder joint injury, and having undergone other surgeries within the past 6 months;
* Patients who cannot complete the entire cycle or drop out midway;
* Presence of serious postoperative complications, such as wound infection, venous thromboembolism, etc.

Where this trial is running

Beijing

• Peking University Third Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Shuang Ren, Doctor

Conditions: Rotator Cuff Tear, Rotator cuff tear, Wearable device, Remote rehabilitation