Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training 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 simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.

Official Title
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A Study on Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Robotic Gait Training on Gait Function in Stroke Patients With Gait Impairment

Conditions
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Stroke

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 19 - 79 years More than 3 months post stroke Functional ambulation classification (FAC) (1 4) Exclusion Criteria: History of serious neurological disease other than stroke Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10) History of psychiatric disease Contraindicated to tDCS

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 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: Brain stimulation<br>* tDCS brain stimulation on leg motor areas was applied to stroke patients.<br>Device: Treadmill gait training<br>* Lokomat robot training was applied to stroke patients.<br>|
| Active Comparator: Gait training with sham brain stimulation<br>Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas | Device: Treadmill 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 | Measurement of the time it takes a subject to walk 10m with self selected gait speed. 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 4 weeks); after 4 weeks from intervention termination (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Berg Balance Scale (BBS) | Measurement of balance function. A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Score the lowest performance. Total Score = 56. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Timed Up and Go test (TUG) | 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Changes in Brain activation of resting-state functional MRI | Measure of Neuroplasticity | session 0 (initial visit); session 10 (at approximately 4 weeks) | 
| Change in Geriatric Depression Scale (GDS) | Measure of depression. The grid sets a range of 0-9 as normal, 10-19 as mildly depressed, and 20-30 as severely depressed. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Changes in motor evoked potential | Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Fugl-Meyer Assessment | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Functional ambulatory category | The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The higher the score, the better the walking ability. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Modified Bathel index (MBI) | The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Muscle Manual Test (MMT) | Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Range of Motion (ROM) | Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) | 
| Change in Modified Ashworth Scale(MAS) | measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult. | session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up) |