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临床试验/NCT04985864
NCT04985864已完成不适用

A Study on Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Robotic Gait Training on Gait Function in Stroke Patients With Gait Impairment

Yun-Hee Kim2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年8月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
Yun-Hee Kim
入组人数
24
试验地点
2
主要终点
Change in 10 meter walk test
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to investigate the effects of simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 79 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age: 19 - 79 years
  • •More than 3 months post stroke
  • •Functional ambulation classification (FAC) (1~4)

排除标准

  • •History of serious neurological disease other than stroke
  • •Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
  • •History of psychiatric disease
  • •Contraindicated to tDCS

结局指标

主要结局

Change in 10 meter walk test

时间窗: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

Measurement of the time it takes a subject to walk 10m with self selected gait speed. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

次要结局

  • Change in Timed Up and Go test (TUG)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Changes in motor evoked potential(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Geriatric Depression Scale (GDS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Fugl-Meyer Assessment(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Functional ambulatory category(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Modified Ashworth Scale(MAS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Changes in Brain activation of resting-state functional MRI(session 0 (initial visit); session 10 (at approximately 4 weeks))
  • Change in Berg Balance Scale (BBS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Muscle Manual Test (MMT)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Modified Bathel index (MBI)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
  • Change in Range of Motion (ROM)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))

研究者

发起方
Yun-Hee Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yun-Hee Kim

Professor

Samsung Medical Center

研究点 (2)

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