Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Changes Postural Assessment Scale For Stroke
研究概览
简要总结
16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.
Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.
Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.
The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up & Go and the 10 meter walking test.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First Ever Stroke
- •Motor or sensory deficit
- •Understands and follows orders
- •Signed inform consent
排除标准
- •One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
结局指标
主要结局
Changes Postural Assessment Scale For Stroke
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.
Changes Time Up & Go
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.
Changes Four Square Step Test
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.
Changes Trunk Impairment Scale
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.
Changes 10 meter walking test
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
10 meter walking test, the faster the better
Changes Berg Balance Scale
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.
次要结局
未报告次要终点
研究者
Bornheim Stephen
Assistant Professor
University of Liege