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Recruiting NCT07412184

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

No phase Interventional Rotator Cuff Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wearable device rehabilitation, Offline Traditional Rehabilitation.
Who it may be relevant to
Registry conditions: Rotator Cuff Tear. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.

Detailed description

In this randomized controlled clinical study, patients with unilateral rotator cuff tears were included. Starting from the fifth week after surgery, they were randomly assigned to either an online wearable device training group or an offline traditional rehabilitation group, with analyses conducted through functional tests and assessments. The study investigated the impact of wearable device rehabilitation on functional recovery in patients with rotator cuff tears and compared it with offline traditional rehabilitation to verify its efficacy.

Interventions

  • Device Wearable device rehabilitation
    Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
  • Other Offline Traditional Rehabilitation
    Offline Traditional Rehabilitation

Primary outcome measures

  • Joint range of motion [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Upper Limb Closed-Chain Stability Test [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • FMS Shoulder Mobility Test [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Isometric Strength Test [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Surface electromyography [Time frame: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.]
Secondary outcome measures (3)
  • Constant- Murley score [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • American Shoulder and Elbow Surgeon's Form [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]
  • Western Ontario Rotator Cuff Index [Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07412184 · M20250763

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗