Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in 10 meter walk test from baseline in gait speed
研究概览
简要总结
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: more than 18 years
- •More than 6 months post stroke
- •Functional ambulation classification (FAC) (1~4)
排除标准
- •Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- •Difficult to understand experimental tasks because of extremely severe cognitive impairment
- •History of disorders involving central nervous system
- •History of psychiatric disease
- •implanted objects that would contraindicate tDCS
研究组 & 干预措施
Robot gait training with brain stimulation
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
干预措施: Robot gait training (Device)
Robot gait training with brain stimulation
Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
干预措施: Brain stimulation (Device)
Robot gait training without brain stimulation
Lokomat robot training and sham tDCS on the leg motor areas
干预措施: Robot gait training (Device)
结局指标
主要结局
Change in 10 meter walk test from baseline in gait speed
时间窗: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
次要结局
- Change in Functional ambulatory category from baseline in gait function(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Change on gait function (muslce activation)(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Change in Berg Balance Scale from baseline in balance(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Changes in Brain activation of resting-state functional MRI(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Change on gait function (kinematic)(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Change in Timed Up and Go test from baseline in balance(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Change on gait function (kinetic)(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))
- Changes in motor evoked potentia(session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up))