Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Four Square Step Test
研究概览
简要总结
Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.
详细描述
This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute stroke
- •Able to walk 10m independently
- •High risk of falling
排除标准
- •Severe functional limitations
- •Cognitive impairment
结局指标
主要结局
Four Square Step Test
时间窗: Change from Baseline in Risk of Falls at 3 months
次要结局
- Berg Balance Scale(Baseline, Week 2, Week 4 and Week 12)
- Occurrence of Falling Index(Baseline, Week 2, Week 4 and Week 12)
- Overall Stability Index(Baseline, Week 2, Week 4 and Week 12)
- Falls Efficacy Scale - International(Baseline, Week 2, Week 4 and Week 12)
- Six-minute walk test(Baseline, Week 2, Week 4 and Week 12)
- Sit to Stand Test(Baseline, Week 2, Week 4 and Week 12)
研究者
Suellen Marinho Andrade
Professor, PhD
Federal University of Paraíba