Severe hemiparatic stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Keio University Hospital Department of rehabilitation medicine