Acute stroke (Cerebral infarction, Cerebral hemorrhage)
Conditions
Interventions
Gait training utilizing HAL(hybrid assistive limb, HAL-ML05) for 40 minutes and conventional physical therapy for 20 minutes per day, 5 times a week, combined with conventional physical therapy for 60
Sponsors
Ichinomiya Nishi Hospital Department of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age:20-89 years old 2)Confirmation of acute ischemic or hemorrhagic stroke lesion on MRI/CT, associated with hemiplegia 3)Time since stroke onset within 7-14 days. 4)Functional Ambulation Category (FAC) score of 0-2 5)Patient can ensure more than 4 weeks from intervention initiation. 6) Patient can consent by a document.
Exclusion criteria
Exclusion criteria: 1)Patient who cannot be suitable for HAL. 2)Patient who cannot walk with HAL. 3)Disturbance of consciousness 4)MMSE score is less than 23. 5)Pre-stroke mRS score is above 2. 6)Severe cardio-pulmonary dysfunction( NYHA; stage III or IV) 7)Patient treated with intravenous drip or oxygen inhalation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event(accident during HAL therapy,stroke recurrence,complication of severe systemic disease) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Impairment Outcome Measures Brunnstrom stage (BRs) 12grade hemiplesia functional test Fugl-meyer assessment 6m-Gait speed,Stride,Cadence,Gait distance for 6 min NIHSS Activity/Disability Outcome Measures modified Rankin Scale (mRS) Barthel Index (BI) Functional Independence Measure (FIM) Others MMSE Medical Outcomes Study Short Form 36(SF36) | — |
Countries
Japan
Contacts
Public ContactKeiji Yamaguchi
Ichinomiya Nishi Hospital Department of Neurology
Outcome results
None listed