A study on the efficacy and underlying mechanisms of a hand exoskeleton rehabilitation training system based on brain-machine-EMG coupling for restoring hand function in stroke patients with hemiplegia
Phase 1
Recruiting
- Conditions
- stroke
- Registration Number
- ChiCTR2400088710
- Lead Sponsor
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Meets the diagnostic criteria for stroke (ischemic/hemorrhagic stroke);<br>2. Age = 18 years and = 80 years, no gender restrictions;<br>3. Onset of stroke between two weeks and one year prior;<br>4. Right-handed;<br>5. Normal cognitive function (MMSE score above the threshold for the corresponding educational level);<br>6. Able to tolerate 1-2 hours of treatment;<br>7. Presence of hand motor function impairment;<br>8. Understands, agrees to participate in this study, and signs the informed consent form.
Exclusion Criteria
- Presence of contraindicated neural modulation implants in or on the body (e.g., ferromagnetic implants, pacemakers, etc.);<br>2. History of epilepsy, mental disorders, or other diseases with severe cognitive or emotional dysfunction;<br>3. Other conditions or factors affecting limb movement, such as fractures, severe arthritis, amputation, etc.;<br>4. History of using drugs that affect central nervous system excitability within the past month;<br>5. Women who are pregnant or breastfeeding.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Action Research Arm Test(ARAT);
- Secondary Outcome Measures
Name Time Method Brunnstrom stage;Manual muscle test(MMT);Modified Ashworth Scale( MAS);Range of motion.(ROM);Minimum Mental State Examination(MMSE);NIH Stroke Scale(NIHSS);Barthel index;Fugl-Meyer assessment scale upper extremity(FMA-UE);Electromyography((EMG);Electroencephalogram(EEG);