Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

Study Overview
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Brief Summary
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A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Detailed Description
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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.

Official Title
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A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training

Conditions
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Stroke

Intervention / Treatment
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* Device: Walkbot
* Device: Conventional physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walkbot<br>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. | Device: Walkbot<br>* 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.<br>Device: Conventional physical therapy<br>* Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.<br>|
| Active Comparator: Conventional physical therapy<br>Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks. | Device: Conventional physical therapy<br>* Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Category(FAC) |  | 9 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motricity Index(MI) |  | 9 weeks from baseline | 
| 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 | 
| Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke