Stroke
Conditions
Brief summary
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.
Interventions
DEVICERobot gait training
Lokomat robot training was applied to stroke patients.
DEVICEBrain stimulation
tDCS brain stimulation on leg motor areas was applied to stroke patients.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10 meter walk test from baseline in gait speed | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional ambulatory category from baseline in gait function | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | Measure of functional ambulatory category |
| Change in Timed Up and Go test from baseline in balance | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | Measure of Timued Up and Go test in balance |
| Change on gait function (kinematic) | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | All participants perform overground walking to assess the change of kinematic using a motion analysis. |
| Change in Berg Balance Scale from baseline in balance | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | Meserue of blance function |
| Change on gait function (muslce activation) | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | All participants perform overground walking to assess the change of muscle activation using a surface EMG. |
| Changes in motor evoked potentia | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle. |
| Changes in Brain activation of resting-state functional MRI | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | Neuroplasticity measure |
| Change on gait function (kinetic) | session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up) | All participants perform overground walking to assess the change of kinetic using a force plate |
Countries
South Korea
Outcome results
None listed