Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment (Upper Extremity)
研究概览
简要总结
Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.
详细描述
Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.
The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Written informed consent
- •Chronic stage of stroke (> 6 months)
- •No active finger extension/hand opening of the paretic side
排除标准
- •Pregnancy
- •Metal implants
- •Pacemaker
研究组 & 干预措施
Ipsilesional stimulation
Ipsilesional stimulation
干预措施: Ipsilesional stimulation (Device)
Contralesional stimulation
Contralesional stimulation
干预措施: Contralesional stimulation (Device)
结局指标
主要结局
Fugl-Meyer Assessment (Upper Extremity)
时间窗: change from baseline to both directly after intervention and 3 months after
次要结局
- Modified Ashworth Scale (MAS)(change from baseline to both directly after intervention and 3 months after)
- National Institute of Stroke Scale (NIHSS)(baseline)
- Stroke Impact Scale(change from baseline to both directly after intervention and 3 months after)
- Hospital Anxiety and Depression Scale(change from baseline to both directly after intervention and 3 months after)
- Neurological Fatigue Index(change from baseline to both directly after intervention and 3 months after)
- Credibility/Expectancy Questionnaire(change from baseline to both directly after intervention and 3 months after)
- Action Research Arm Test (ARAT)(change from baseline to both directly after intervention and 3 months after)
- 10m walking test(change from baseline to both directly after intervention and 3 months after)
- CAHAI-13(change from baseline to both directly after intervention and 3 months after)
- NEO-Fünf-Faktoren Inventar(baseline)
- Berlin Social Support Scale(change from baseline to both directly after intervention and 3 months after)
- Barthel Index(change from baseline to both directly after intervention and 3 months after)
- Arm-A(change from baseline to both directly after intervention and 3 months after)
- Fugl-Meyer Assessment (Lower Extremity)(change from baseline to both directly after intervention and 3 months after)
- Modified Rankin Scale (mRS)(change from baseline to both directly after intervention and 3 months after)
- EQ-5D(change from baseline to both directly after intervention and 3 months after)
- Situational Motivation Scale(change from baseline to both directly after intervention and 3 months after)