NCT04054700Unknown不适用
The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Wolf motor function test
研究概览
简要总结
Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients
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)
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 ≥ 3 months
- •29 ≤ Fugl-Meyer Assessment score
- •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
结局指标
主要结局
Wolf motor function test
时间窗: change from baseline at 4 weeks
an activity indicator, has 15 items for testing functional ability
Fugl-Meyer Assessment
时间窗: change from baseline at 4 weeks
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
次要结局
- Fugl-Meyer Assessment(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Motor status score(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Wolf motor function test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Mean velocity of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Motor activity log(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Action reach arm test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Box and block test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Curvature of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Jerk of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Motor evoked potential over motor cortex of the affected side(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Stroke impact scale 3.0(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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