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临床试验/NCT04054700
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

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

发起方
National Rehabilitation Center, Seoul, Korea
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Joon-Ho Shin

Team manager

National Rehabilitation Center, Seoul, Korea

研究点 (2)

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