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临床试验/NCT02029651
NCT02029651Unknown不适用

Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial

National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2014年1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
59
试验地点
2
主要终点
Fugl-meyer assessment_upper extremity

研究概览

简要总结

The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic stroke patients
  • Medical research council scale >= 2 of finger or wrist flexor/extensor
  • Medical research council scale >= 2 of elbow pronation/supination

排除标准

  • Bilateral weakness of upper extremities
  • Uncontrolled medical or surgical illness
  • Predisposing psychological or neurological disorders
  • Severe aphasia unable to communicate
  • Severe cognitive impairment not to cooperate
  • Severe pain impeding upper extremity rehabilitation

结局指标

主要结局

Fugl-meyer assessment_upper extremity

时间窗: Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention

次要结局

  • Satisfaction about intervention(after 20th intervention)
  • Stroke impact scale(Baseline, after 20th intervention)
  • Modified Ashworth scale of affected upper extremity(Baseline, after 20th intervention)
  • Medical research council scale of muscle strength of affected upper extremity(Baseline,after 20th intervention)
  • Fugl-meyer assessment_upper extremity(Baseline, after 10th intervention, after 20th intervention, 1 month after intervention)
  • Jebsen hand function test(Baseline, after 10th intervention, after 20th intervention, 1 month after intervention)
  • Purdue pegboard(Baseline, after 10th intervention, after 20th intervention, 1 month after intervention)

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

Manager

National Rehabilitation Center, Seoul, Korea

研究点 (2)

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