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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yun-Hee Kim
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in 10 meter walk test
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Robot gait training with brain stimulation
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Intervention: Brain stimulation (Device)
Robot gait training with brain stimulation
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Intervention: Treadmill gait training (Device)
Gait training with sham brain stimulation
Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas
Intervention: Treadmill gait training (Device)
Outcomes
Primary Outcomes
Change in 10 meter walk test
Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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."
Secondary Outcomes
- Change in Timed Up and Go test (TUG)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Changes in motor evoked potential(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Geriatric Depression Scale (GDS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Fugl-Meyer Assessment(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Functional ambulatory category(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Modified Ashworth Scale(MAS)(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(session 0 (initial visit); session 10 (at approximately 4 weeks))
- Change in Berg Balance Scale (BBS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Muscle Manual Test (MMT)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Modified Bathel index (MBI)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Range of Motion (ROM)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
Investigators
Yun-Hee Kim
Professor
Samsung Medical Center