Stroke
Conditions
Keywords
Stroke
Brief summary
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Detailed description
Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training. Experimental group receives robot-assisted-gait-training and conventional gait training. Active comparator group receives conventional gait training only as the same number as the experimental group.
Interventions
DEVICEWalkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
DEVICEConventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Sponsors
P&S Mechanics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age more than 19 and under 80 * Weight under 100kg * Height less than 200cm * Able to walk independently before onset of stroke * Ischemic or hemorrhagic stroke patients * Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment * FAC(Functional Ambulation Category) under 3 (0\ 2) * Subacute stroke patients after 3 days and before 3 months of onset * Be informed of the nature of the study and agreed on written consent voluntarily * Patients taking medications or scheduled medications due to stroke
Exclusion criteria
* Patients with contraindications to weight bearing such as fractures, etc. * Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension * Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training * Patients with severe skin damage and bedsore on wearing part of the trial device * Pregnant or breast-feeding * Participation within 30 days of the other clinical trials * Patients whom the investigator considers inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Ambulation Category(FAC) | 9 weeks from baseline |
Secondary
| Measure | Time frame |
|---|---|
| 10 Meter Walk Test(10MWT) | 9 weeks from baseline |
| 6 Minute Walk Test(6MWT) | 9 weeks from baseline |
| Medical Research Council(MRC) Scale | 9 weeks from baseline |
| Modified Ashworth Scale (MAS) | 9 weeks from baseline |
| Motricity Index(MI) | 9 weeks from baseline |
| Modified Barthel Index(MBI) | 9 weeks from baseline |
| National Institutes of Health Stroke Scale (NIHSS) | 9 weeks from baseline |
| Beck's Depression Inventory test (BDI) | 9 weeks from baseline |
| Treatment Satisfaction Survey | 9 weeks from baseline |
| Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke | 9 weeks from baseline |
Countries
South Korea
Outcome results
None listed