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

INTERVENTION: BMI group: BMI training and conventional occupational therapy Control group: motor imagery training and conventional occupational therapy Control group: motor imagery training and conventional occupational therapy CONDITION: Severe hemiparatic stroke PRIMARY OUTCOME: Change between baseline and 4 weeks after the end of the therapy of Fugl‐Meyer Assessment upper extremity motor score(FMA) SECONDARY OUTCOME: 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 INCLUSION CRITERIA: 1 time from stroke onset longer than 90 days 2 first ever stroke patients satisfied all criteria indicated below a. proprioceptive sensory score on SIAS is more than 1 b knee‐mouth test sore on SIAS is more than 2 c passive range of motion is minus 10 degrees for metacarpophalangeal joint extension d finger test score on SIAS is 1A 3 ability to walk independently in daily life with or without assistance 4 ability to understand and consent the study protocol by himself