The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Spasticity (Modified Ashworth scale)
研究概览
简要总结
Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.
详细描述
In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.
Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •first-ever ischemic stroke;
- •chronic phase of recovery (>6 months);
- •ability to walk 6- meter supported or unsupported;
- •ability to stand at least unsupported for 40-seconds with eyes closed;
- •only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.
排除标准
- •Use of any neuro- or psycho-active medications that alters balance;
- •any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases;
- •ongoing/recent (within 3 months) balance rehabilitation.
研究组 & 干预措施
Arm 1:tDCS
Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Arm 2: Sham tDCS
Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days
干预措施: Sham tDCS (Device)
结局指标
主要结局
Spasticity (Modified Ashworth scale)
时间窗: After 5 days
Modified Ashworth scale(MAS)
次要结局
- Motoneuron excitability (H-reflex latency)(After 5 days)
- Motoneuron excitability(After 5 days)
研究者
Fariba Yadolahi
MD-MPH-PhD candidate
Shahid Beheshti University of Medical Sciences