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临床试验/NCT02210403
NCT02210403已完成不适用

The Influence of tDCS on the Arm and Hand Function in Stroke Patients

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change of Fugl-Meyer assessment (FMA) score

研究概览

简要总结

The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Stroke patients onset > 6 months
  • •First ever stroke
  • •Decreased hand and arm function
  • •Mini Mental State Examination (>24)

排除标准

  • •Depression
  • •Pregnancy
  • •Alcohol abuse
  • •Aneurysm clips
  • •Pacemaker
  • •Neurostimulator
  • •Implemented defibrillator
  • •Magnetically activated implant or device
  • •implemented pump
  • •Spinal cord simulator
  • •Implemented hearing aid
  • •Artificial or prosthetic limb
  • •Metal parts in the body
  • •Any external or internal metal
  • •Artificial heart valve
  • •Other implants
  • •History of brain surgery
  • •Family history of Epilepsy

研究组 & 干预措施

Upper limb motor function training + tDCS

Active Comparator

Bi-hemispheric tDCS with motor function training

干预措施: transcranial direct current stimulation (tDCS) (Device)

upper limb motor function training + sham tDCS

Sham Comparator

sham tDCS with motor function training

干预措施: transcranial direct current stimulation (tDCS) (Device)

结局指标

主要结局

Change of Fugl-Meyer assessment (FMA) score

时间窗: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention

次要结局

  • Change of Modified Ashworth scale (MAS)(Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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