E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change scores over two weeks for the standardised primary outcome measure
研究概览
简要总结
The purpose of this study is to investigate the efficacy, acceptability, and safety of the therapeutic system E-BRAiN for the treatment of stroke-related impairments.
详细描述
This randomized controlled trial, RCT with cross-over design sequentially allocates participants with stroke-related impairment to both a two week course of conventional rehabilitation therapy and a two week course of therapy using the therapy system E-BRAiN (purpose-built therapy system using a socially interactive humanoid robot); participants are randomly allocated to the sequences "conventional => robot" or "robot => conventional". Stroke survivors with one of the target syndromes, i.e. mild arm paresis, or moderate to severe arm paresis, or visuospatial neglect are invited to participate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at study entry ≥ 18 years
- •Stroke (ischemic stroke, non-traumatic intracerebral haemorrhage, subarachnoidal haemorrhage)
- •Incomplete arm paresis (Motricity Index, arm score >1 [Min] and < 100 [Max]) or
- •Visuospatial neglect (clinical signs and NET subtest "star cancellation" score < 50)
- •Candidate able to consent and provides informed consent or
- •legal representative provides informed consent
排除标准
- •Pregnant or breast feeding
- •Obliged to live in an institution by law or public authority
- •With case presentation arm paresis: another condition that causes arm paresis is present
- •With case presentation visuospatial neglect: another condition that causes a relevant visual-perceptual deficit that cannot be compensated is present; exception: homonymous visual field deficits are not an exclusion criterion
结局指标
主要结局
Change scores over two weeks for the standardised primary outcome measure
时间窗: 2 weeks
Change scores are difference scores for assessments taken two weeks apart. Changes scores are based on standardised outcome measures. Assessment scores for each measure (see below) are standardised using the known variance in stroke survivor populations for the respective measure. The following assessments will be used for standardised outcome measures: Nine-Hole-Peg-Test, NHPT (finger dexterity) and Box-and-Block Test, BBT (gross manual dexterity) (for participants with mild arm paresis); Fugl Meyer, Arm motor score, FM Arm (selective arm and hand movement capacity) (participants with moderate to severe arm paresis); Neglect-Test, NET (spatial visual attention) (participants with visual neglect).
次要结局
- Work alliance(2 weeks)
- Drop-out rate(2 weeks)
- Goal attainment(2 weeks)
- Change scores over two weeks for "Motivation for therapy"(2 weeks)
- Adverse events(2 weeks)
- Change scores over two weeks for "Emotional distress"(2 weeks)