NCT04077814已完成不适用
Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial
Federal University of Health Science of Porto Alegre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Kinematic gait anaysis.
研究概览
简要总结
The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with ischemic or hemorrhagic stroke diagnosis.
- •Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
- •Minimal cognitive ability to understand commands
- •Able to walk 10 meters unassisted or with minimal assistance
排除标准
- •No current use of antiepileptic drugs for seizures
- •Secondary musculoskeletal disorder involving the lower limb
- •Contraindication for electrical stimulation
结局指标
主要结局
Kinematic gait anaysis.
时间窗: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
次要结局
- Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Kinetic gait anaysis.(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Postural Control(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Functional Mobility(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Muscular tone assessed by the Modified Ashworth Scale(The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.)
- Serum levels of Brain-derived neurotrophic fator (BDNF).(The outcome will be assessed at baseline and 2 weeks after the intervention.)
- Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)(The outcome will be assessed at baseline and 2 weeks after the intervention.)
- Serum levels of insulin-like growth factors 1 (IGF-1)(The outcome will be assessed at baseline and 2 weeks after the intervention.)
研究者
Aline de Souza Pagnussat
Principal Investigator
Federal University of Health Science of Porto Alegre
研究点 (1)
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