| Trial name or title |
Clinical trial of robot‐assisted‐gait‐training (RAGT) in stroke patients (Walkbot) |
| Methods |
Randomised 2 arms |
| Participants |
Inclusion criteria
Age older than 19 years and younger than 80 years
Weight under 100 kg
Height less than 200 cm
Able to walk independently before onset of stroke
Ischaemic or haemorrhagic stroke patients
Motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
FAC under 3 (0 ˜ 2)
Subacute stroke patients, i.e. after 3 days and before 3 months of stroke onset
Be informed of the nature of the study and agreed on written consent voluntarily
Taking medications or scheduled medications due to stroke
Exclusion criteria
Contraindications to weight bearing such as fractures, etc.
Uncontrolled stage 2 hypertension (systolic over 160 mm Hg or diastolic over 100 mm Hg) or with uncontrolled orthostatic hypotension
Cardiopulmonary disease or other underlying diseases that cannot tolerate gait training
Severe skin damage and bedsore on wearing part of the trial device
Pregnant or breastfeeding
Participationin other clinical trials within 30 days
People whom the investigator considers inappropriate to participate in the study
|
| Interventions |
Walkbot (robot‐assisted gait training) 30 minutes and conventional physical therapy 30 minutes per day to be administered 5 times a week for 3 weeks
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks
|
| Outcomes |
Primary outcome measure
Secondary outcome measures
Motricity Index
10‐metre walk test
6‐minute walk test
Medical Research Council
Modified Ashworth Scale
Fugl‐Meyer Assessment
Modified Barthel Index
National Institutes of Health Stroke Scale
Beck Depression Inventory
Treatment Satisfaction Survey
|
| Starting date |
March 2014 |
| Contact information |
P&S Mechanics Co., Ltd. |
| Notes |
|