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临床试验/NCT05275114
NCT05275114已完成不适用

Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Yun-Hee Kim2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年3月11日最近更新:
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 Fugl-Meyer Assessment

研究概览

简要总结

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 19 to 80 years
  • Less than 58 FMA Upper scores
  • Patients whose lesions do not include stimulation regions
  • Patients with stroke with more than 3 months of onset

排除标准

  • Difficult to communicate due to severe language impairment.
  • Accompanied by an existing serious neurogenic disease
  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
  • If there are difficulties in conducting the research
  • Any patients who are judged by the investigator to be difficult to participate in this study
  • Patients with contraindicated MRI scans

结局指标

主要结局

Change in Fugl-Meyer Assessment

时间窗: Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)

The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

次要结局

  • Change in Box and Block test(Baseline(initial visit); Session 10 (at approximatel 4 weeks))
  • Change in Grip & Tip pinch strength(Baseline(initial visit); Session 10 (at approximatel 4 weeks))
  • Changes in Brain activation of resting-state functional MRI([Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)])
  • Change in Jebsen-Taylor hand function test(Baseline(initial visit); Session 10 (at approximatel 4 weeks))
  • Change in 9-hole pegboard test(Baseline(initial visit); Session 10 (at approximatel 4 weeks))
  • Change in Sequential finger tapping reaction time and accruacy(Baseline(initial visit); Session 10 (at approximatel 4 weeks))
  • Changes in motor evoked potential([Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)])

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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