Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Chronic Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- kinematic data during scale for the assessment
研究概览
简要总结
Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.
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
- Single (Participant)
盲法说明
Participant does not know the allocation.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiplegic patients secondary to first cerebrovascular accidents
- •Onset ≥ 6 months
- •Fugl-Meyer Assessment score ≥ 19
- •Cognitively intact enough to understand and follow the instructions from the investigator
排除标准
- •Severe upper extremity pain that could interfere with rehabilitation therapy
- •Neurological disorders other than stroke that can cause motor deficits
- •Uncontrolled severe medical conditions.
研究组 & 干预措施
Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks
干预措施: Robot and tDCS on-line (Device)
Robot and tDCS on-line after sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks
干预措施: Robot and tDCS on-line after sham tDCS (Device)
结局指标
主要结局
kinematic data during scale for the assessment
时间窗: 5 weeks after baseline
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
次要结局
- kinematic data during scale for the assessment(baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Fugl-Meyer Assessment - upper extremity(baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Wolf Motor Function Test(baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Action reach arm test(baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
- Motor activity log(baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline)
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea