Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the improvement in upper extremity performance assessed using Jebsen-Taylor test
研究概览
简要总结
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.
详细描述
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •age 18-80 years;
- •single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
- •stroke onset at least six months before;
- •hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).
排除标准
- •previous strokes;
- •epilepsy and other neurological conditions;
- •proprioceptive or tactile anesthesia;
- •shoulder or hand pain;
- •severe joint deformity;
- •severe chronic disease;
- •inability to give provide informed consent due to severe aphasia or cognitive impairment;
- •left handedness before the stroke.
研究组 & 干预措施
Somatosensory stimulation
Active group
干预措施: Relief band (Somatosensory stimulation) (Device)
Control group
Placebo stimulation
干预措施: Placebo stimulation (Device)
结局指标
主要结局
the improvement in upper extremity performance assessed using Jebsen-Taylor test
时间窗: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
次要结局
- Compliance with the interventions, assessed through a daily written log, and oral reports of the patients(immediately after the treatment)
- Adverse events(at end of treatment)