A Study on Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Robotic Gait Training on Gait Function in Stroke Patients With Gait Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Yun-Hee Kim
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in 10 meter walk test
研究概览
简要总结
The purpose of this study was to investigate the effects of simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 19 - 79 years
- •More than 3 months post stroke
- •Functional ambulation classification (FAC) (1~4)
排除标准
- •History of serious neurological disease other than stroke
- •Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
- •History of psychiatric disease
- •Contraindicated to 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: Brain stimulation (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: Treadmill gait training (Device)
Gait training with sham brain stimulation
Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas
干预措施: Treadmill gait training (Device)
结局指标
主要结局
Change in 10 meter walk test
时间窗: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Measurement of the time it takes a subject to walk 10m with self selected gait speed. 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 Timed Up and Go test (TUG)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Changes in motor evoked potential(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Geriatric Depression Scale (GDS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Fugl-Meyer Assessment(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Functional ambulatory category(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Modified Ashworth Scale(MAS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Changes in Brain activation of resting-state functional MRI(session 0 (initial visit); session 10 (at approximately 4 weeks))
- Change in Berg Balance Scale (BBS)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Muscle Manual Test (MMT)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Modified Bathel index (MBI)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))
- Change in Range of Motion (ROM)(session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up))