NCT02818608已完成不适用
Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb 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 51 人开始时间: 2017年8月14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
- 51
- 试验地点
- 1
- 主要终点
- Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
研究概览
简要总结
The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe 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
- 30 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 and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
- •Ability to reach 60 degrees in the shoulder flexion
- •Minimal cognitive ability to understand commands
- •No current use of antiepileptic drugs for seizures
排除标准
- •Painful shoulder, adhesive capsulitis or glenohumeral subluxation
- •Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
结局指标
主要结局
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
时间窗: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
3-D motion analysis system
次要结局
- Manual dexterity assessed by means of the block and box test(Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
- Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)(Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
- Muscular tone assessed by the Modified Ashworth Scale(Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
- Grip force assessed by means of dynamometer(Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
- Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale(Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
研究者
Aline de Souza Pagnussat
PhD
Federal University of Health Science of Porto Alegre
研究点 (1)
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