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

Yun-Hee Kim1 个研究点分布在 1 个国家目标入组 24 人2021年8月1日

适应症Stroke

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Stroke
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
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年8月1日

结束日期

2022年5月16日

最后更新

3年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Yun-Hee Kim

责任方

Sponsor Investigator

主要研究者

Yun-Hee Kim

Professor

Samsung Medical Center

入排标准

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

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))