Stroke
Conditions
Keywords
Stroke, transcranial direct current stimulation, robotic rehabilitation, gait
Brief summary
1. 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 2. Subjects chronic stroke patients with gait impairment 3. 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
Interventions
DEVICEtDCS
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.
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Ambulatory Category (FAC) | Baseline | Assesses functional ambulation in patients undergoing physical therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-meter walk test | Baseline | Time for walking 10 meters |
| 6-min walk test | Baseline | Walking distance for 6 min |
| Modified Rankin's Scale | Baseline | — |
| Fugl-Meyer assessment scale for lower extremity | Baseline | Assess the function of lower extremity in stroke patients |
| Motor evoked potential | Baseline | Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation |
Countries
South Korea
Outcome results
None listed