Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.

Official Title
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Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot gait training
* Device: Brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: more than 18 years More than 6 months post stroke Functional ambulation classification (FAC) (1 4) Exclusion Criteria: Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) Difficult to understand experimental tasks because of extremely severe cognitive impairment History of disorders involving central nervous system History of psychiatric disease implanted objects that would contraindicate tDCS

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot gait training with brain stimulation<br>Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas | Device: Robot gait training<br>* Lokomat robot training was applied to stroke patients.<br>Device: Brain stimulation<br>* tDCS brain stimulation on leg motor areas was applied to stroke patients.<br>|
| Active Comparator: Robot gait training without brain stimulation<br>Lokomat robot training and sham tDCS on the leg motor areas | Device: Robot gait training<br>* Lokomat robot training was applied to stroke patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 meter walk test from baseline in gait speed | Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: Please walk this distance at your normal pace when I say go. | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Berg Balance Scale from baseline in balance | Meserue of blance function | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Change in Functional ambulatory category from baseline in gait function | Measure of functional ambulatory category | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Change in Timed Up and Go test from baseline in balance | Measure of Timued Up and Go test in balance | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Change on gait function (kinematic) | All participants perform overground walking to assess the change of kinematic using a motion analysis. | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Change on gait function (kinetic) | All participants perform overground walking to assess the change of kinetic using a force plate | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Change on gait function (muslce activation) | All participants perform overground walking to assess the change of muscle activation using a surface EMG. | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Changes in motor evoked potentia | measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle. | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 
| Changes in Brain activation of resting-state functional MRI | Neuroplasticity measure | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) |