Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Functional Ambulatory Category (FAC)
Study Overview
Brief Summary
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Robot + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Intervention: tDCS (Device)
Robot + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Intervention: Robotic-assisted gait training (Device)
Robot + sham tDCS
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Intervention: tDCS (Device)
Robot + sham tDCS
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Intervention: Robotic-assisted gait training (Device)
Outcomes
Primary Outcomes
Functional Ambulatory Category (FAC)
Time Frame: 4 weeks after treatment
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Time Frame: Baseline
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Time Frame: 1 day after treatment
Assesses functional ambulation in patients undergoing physical therapy
Secondary Outcomes
- 6-min walk test(4 weeks after treatment)
- Fugl-Meyer assessment scale for lower extremity(4 weeks after treatment)
- Motor evoked potential(1 day after treatment)
- 10-meter walk test(4 weeks after treatment)
- Modified Rankin's Scale(4 weeks after treatment)
- 10-meter walk test(1 day after treatment)
- 10-meter walk test(Baseline)
- 6-min walk test(Baseline)
- 6-min walk test(1 day after treatment)
- Modified Rankin's Scale(Baseline)
- Modified Rankin's Scale(1 day after treatment)
- Fugl-Meyer assessment scale for lower extremity(Baseline)
- Fugl-Meyer assessment scale for lower extremity(1 day after treatment)
- Motor evoked potential(Baseline)
Investigators
Byung-Mo Oh
Clinical Professor
Seoul National University Hospital