Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
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
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
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
