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Recruiting NCT07422714

Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder

No phase Interventional Range of Motion, Articular

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: Artificial and intelligent combination of shoulder joint function exercise, Traditional rehabilitation training, Intelligent rehabilitation training.
Who it may be relevant to
Registry conditions: Range of Motion, Articular. Basic parameters: 40 years — 60 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 →

Overview

A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation

Detailed description

Frozen Shoulder (FS), as a diffuse inflammatory disease, involves the glenohumeral joint, joint capsule, synovial tissues, and glenohumeral ligaments. Current management of FS includes conservative and surgical treatments. However, there remains room for improvement in the efficacy of conservative rehabilitation for FS. This study intends to enroll subjects diagnosed with Frozen Shoulder (FS) and conduct a randomized controlled trial to compare the safety and effectiveness of traditional rehabilitation versus remote intelligent rehabilitation for FS. Evaluations will include patient pain scores, shoulder joint function, and magnetic resonance imaging findings to observe the therapeutic effects of different interventions. This study aims to address how to enhance the rationality of FS patient management and identify the optimal rehabilitation treatment plan, thereby assisting FS patients in restoring daily living and motor functions as soon as possible.

Interventions

  • Other Artificial and intelligent combination of shoulder joint function exercise
    Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined
  • Other Traditional rehabilitation training
    Shoulder joint function training is performed by a rehabilitation therapist
  • Other Intelligent rehabilitation training
    Shoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system

Primary outcome measures

  • Constant-Murley Shoulder Assessment Score Scale [Time frame: Week 0、Week 4 and Week 8]
Secondary outcome measures (5)
  • Visual Analogue Scale [Time frame: Week 0、Week 4 and Week 8]
  • Shoulder Range of Motion [Time frame: Week 0、Week 4 and Week 8]
  • Shoulder muscle strength [Time frame: Week 0 、Week 4 and Week 8]
  • Shoulder joint MRI [Time frame: Week 0 、Week 4 and Week 8]
  • Exercise completion rate [Time frame: Week 0 、Week 4 and Week 8]

Eligibility 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.

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: NCT07422714 · M20251134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗