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临床试验/NCT03460886
NCT03460886已完成不适用

Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Changes in motor evoked potential

研究概览

简要总结

The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.

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, Outcomes Assessor)

入排标准

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

入选标准

  • Chronic stroke patients with 6 months after onset.
  • Functional ambulation category ≥ 3

排除标准

  • patients who needs assist in surface level walking
  • patients with mini mental status exam score under 9
  • patients with implantable electronic device
  • metal device inside skull
  • history of epilepsy
  • pregnancy

结局指标

主要结局

Changes in motor evoked potential

时间窗: before and after intervention (approximately 30 minutes)

measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.

次要结局

  • Changes in 10 meter walking test(before and after intervention (approximately 30 minutes))
  • Timed up and go test(before and after intervention (approximately 30 minutes))
  • Changes in Fugl Meyer Assessment(before and after intervention (approximately 30 minutes))
  • Functional ambulatory category(before and after intervention (approximately 30 minutes))
  • Changes in motricity index(before and after intervention (approximately 30 minutes))
  • Modified ashworth scale(before and after intervention (approximately 30 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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