Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.
- Conditions
- Severe hemiparatic stroke
- Registration Number
- JPRN-UMIN000026372
- Lead Sponsor
- Department of rehabilitation medicine,Keio University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1.serious medical conditions for rehabilitation indicated below a. severe heart disease b. uncontrolled hypertension c. history of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment d. severe hepatic or renal dysfunction e. severe orthopedic impairment f. severe cognitive or psychiatric disorder g. other serious medical conditions 2. pacemaker or other implanted stimulator use 3. history of seizures within 90 days before enrollment 4. participation of other clinical trial for regulatory approval within 90 days before enrollment 5.receiving other special neurorehabilitation technique for upper extremity paresis, such as trans cranial magnetic stimulation, therapeutic electrical stimulation, constraint induced movement therapy, and repetitive facilitative exercise, within 90 days before enrollment 6. injection of botulinum toxin or phenol for treatment of upper limb spasticity within 90 days before enrollment 7. impossible to record electroencephalography because of skin status or skull deformity 8. other critical problems to participate the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA)
- Secondary Outcome Measures
Name Time Method 1. Sub-scales of FMA 2. Barthel Index 3. Motor Activity Log 4. Stroke Impairment Assessment Set 5. Goal Attainment Scaling 6. electromyography of finger extensor muscles 7. electroencephalography during BMI training 8. MAS 9. SS-QOL 10. ARAT