Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

Study Overview
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Brief Summary
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Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients Subjects chronic stroke patients with gait impairment Methods Group 1: Robotic-assisted gait training with anodal tDCS (45 min) Group 2: Robotic-assisted gait training with sham tDCS (45 min) Duration of treatment: 2 weeks, 5 times a week Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

Official Title
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Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS
* Device: Robotic-assisted gait training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke patients who diagnosed by computed tomography or magnetic resonance imaging Hemiplegic patients due to unilateral lesion Patients in chronic stage after 6 months from stroke onset Patients with gait impairment (FAC <= 4) Adult (Age >= 18) Exclusion Criteria: Unstable vital sign History of seizure or cranial operation unable to walk before stroke bilateral hemispheric lesions metalic implant (cardiac pacemaker, artificial cochlear, etc.) severe cognitive deficit, MMSE < 10 severe aphasic patient who cannot communicate at all

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 + anodal tDCS<br>Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min | Device: tDCS<br>* tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.<br>* Other names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany);Device: Robotic-assisted gait training<br>* Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments<br>* Other names: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea);|
| Sham Comparator: Robot + sham tDCS<br>Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min | Device: tDCS<br>* tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.<br>* Other names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany);Device: Robotic-assisted gait training<br>* Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments<br>* Other names: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulatory Category (FAC) | Assesses functional ambulation in patients undergoing physical therapy | Baseline | 
| Functional Ambulatory Category (FAC) | Assesses functional ambulation in patients undergoing physical therapy | 1 day after treatment | 
| Functional Ambulatory Category (FAC) | Assesses functional ambulation in patients undergoing physical therapy | 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walk test | Time for walking 10 meters | Baseline | 
| 10-meter walk test | Time for walking 10 meters | 1 day after treatment | 
| 10-meter walk test | Time for walking 10 meters | 4 weeks after treatment | 
| 6-min walk test | Walking distance for 6 min | Baseline | 
| 6-min walk test | Walking distance for 6 min | 1 day after treatment | 
| 6-min walk test | Walking distance for 6 min | 4 weeks after treatment | 
| Modified Rankin's Scale |  | Baseline | 
| Modified Rankin's Scale |  | 1 day after treatment | 
| Modified Rankin's Scale |  | 4 weeks after treatment | 
| Fugl-Meyer assessment scale for lower extremity | Assess the function of lower extremity in stroke patients | Baseline | 
| Fugl-Meyer assessment scale for lower extremity | Assess the function of lower extremity in stroke patients | 1 day after treatment | 
| Fugl-Meyer assessment scale for lower extremity | Assess the function of lower extremity in stroke patients | 4 weeks after treatment | 
| Motor evoked potential | Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation | Baseline | 
| Motor evoked potential | Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation | 1 day after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, transcranial direct current stimulation, robotic rehabilitation, gait