A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Phase 1
- Conditions
- Stroke (Cerebral infarction, Cerebral hemorrhage)
- Registration Number
- JPRN-UMIN000022410
- Lead Sponsor
- niversity of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)It is difficult to perform the voluntary movement of the limbs in accordance with the instructions due to the disturbance of consciousness. 2)Patients has a complication, for example, severe cardiac disease and musculoskeletal system which can disturb the treatment using HAL. 3)Patients who investigator or sub investigator deemed inappropriate In this clinical trial. 4)Patients received magnetic stimulation, electrical stimulation and so no, neuromodulation therapy prior to the this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Ambulation Category (FAC)
- Secondary Outcome Measures
Name Time Method Brunnstrom stage (BRs) 12grade hemiplesia functional test NIHSS Fugl-meyer assessnment (FMA) 6m-Gait speed, Stride, Cadence, Gait-form Gait distance for 6 min modified Rankin Scale (mRS) Barthel Index (BI) motor Functional Independence Measure (motor FIM) MMSE Duration of hospitalization and research Frequency of HAL treatment and conventional physiotherapy Adverse event EMG TMS-MEP F wave, H wave EEG fMRI, resting-state fMRI, DTI Oxidatiove stress index Platelet aggregation