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
适应症
干预措施
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
- 1
- 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
- 否
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
研究组 & 干预措施
Hand Tasks + M1(1mA) & aIPS(1mA) tDCS
Experimental
20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS
干预措施: tDCS stimulation with hand task (Device)
Hand Tasks + Sham tDCS
Active Comparator
20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS
干预措施: sham tDCS stimulation with hand task (Device)
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 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))
- Change in Jebsen-Taylor hand function test(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
研究点 (1)
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