Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

Study Overview
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Brief Summary
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Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

Detailed Description
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This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

Official Title
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Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Walkbot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First stroke attack Within 3 months after stroke onset Supratentorial stroke Unilateral stroke Exclusion Criteria: Bilateral stroke infratentorial stroke Cognitive disabilities or serious psychiatric illness. Difficulty in walking due to orthopedic problems.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walkbot<br>Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all. | Device: Walkbot<br>* Robot assisted gait training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention |  | at the first day of intervention and 8 weeks after the first day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ambulation category | The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere). | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | 
| Fugl-meyer assessment |  | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | 
| Medical research council | The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed) | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | 
| Trunk control test |  | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day |