Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Functional Ambulatory Category (FAC)
研究概览
简要总结
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Robot + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
干预措施: tDCS (Device)
Robot + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
干预措施: 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
干预措施: tDCS (Device)
Robot + sham tDCS
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
干预措施: Robotic-assisted gait training (Device)
结局指标
主要结局
Functional Ambulatory Category (FAC)
时间窗: 4 weeks after treatment
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
时间窗: Baseline
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
时间窗: 1 day after treatment
Assesses functional ambulation in patients undergoing physical therapy
次要结局
- 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)
研究者
Byung-Mo Oh
Clinical Professor
Seoul National University Hospital