The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postural control
研究概览
简要总结
Purpose:
The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program.
To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility.
Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions
Experimental: Arm 1
tDCS brain stimulation and simultaneous balance training
Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days.
No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training
详细描述
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.
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
Transcranial direct current stimulation
ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training.
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
ARM 2
ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
干预措施: Sham (Device)
结局指标
主要结局
Postural control
时间窗: After 5 days
Functional dynamic balance
次要结局
- Change of Static Balance(1 month)
- Static Balance(After 5 days)
- Change of Static Balance(1 week)
研究者
Fariba Yadolahi
Fariba Yadolahi-MD-MPH-PhD Candidate in physical therapy
Shahid Beheshti University of Medical Sciences