NCT04055597Unknown不适用
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of Functional ataxia rating scale - upper limb
研究概览
简要总结
Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Stroke with cerebellar hemorrhage or infarction
- •ataxia or tremor on upper extremities secondary to stroke
- •Cognitively intact enough to understand and follow the instructions from the investigator
排除标准
- •History of surgery of affected upper limb
- •Fracture of affected upper limb
研究组 & 干预措施
Robot and tDCS on-line
Experimental
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
干预措施: Robot and tDCS on-line (Other)
Robot and sham tDCS
Sham Comparator
Combined sham tDCS and upper extremity rehabilitation robot
干预措施: Robot and sham tDCS (Other)
结局指标
主要结局
Change of Functional ataxia rating scale - upper limb
时间窗: Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline
Change of Functional ataxia rating scale - upper limb
Change of Scale for the assessment and rating of ataxia
时间窗: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Change of Scale for the assessment and rating of ataxia
次要结局
- Fugl-Meyer Assessment - upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Composite cerebellar functional severity score(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Jerk during reaching and finger pointing(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Smoothness during reaching and finger pointing(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Behavioral activation system/behavioral inhibition system scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Beck's depression index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Stroke rehabilitation motivation scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Intrinsic motivation inventory(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Numeric rating scale for upper extremity pain(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Functional reaching test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- modified Barthel index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- % maximal voluntary contraction from upper extremity muscles during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Kinematic data during scale for the assessment and rating of ataxia(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Scale for the assessment and rating of ataxia(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Functional ataxia rating scale - upper limb(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Kinematic data during scale during the Functional ataxia rating scale - upper limb(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea
研究点 (2)
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