Neglect Treatment by Prism Adaptation in the Acute Phase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Unilateral spatial neglect
研究概览
简要总结
This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. This syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. Patients at a first event brain injury hospitalized into the Neurology and Neurosurgery Departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). The effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. These results can have a strong impact on the long-term functional outcome of these patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery);
- •Structural images of the brain lesion available (magnetic resonance or tomographic scans);
- •Good Normal (or corrected) visual acuity;
- •Presence of USN, as assessed by a standard neuropsychological evaluation.
排除标准
- •Previous neurological disorder and/or current or previous psychiatric disease.
- •Presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ;
- •Presence of difficulty in task's comprehension preventing its completion;
- •Impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).
结局指标
主要结局
Unilateral spatial neglect
时间窗: Day 0; Day 5; 12 weeks after the end of the protocol
Scores in the neuropsychological tasks administered just before and after the rehabilitation protocol: BEN battery, with the number of lateralized omissions in target cancellation, drawing and reading; bisection bias for the line bisection test
Disability measures
时间窗: Day 0; Day 5; 12 weeks after the end of the protocol
Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)
Functional measures
时间窗: Day 0; Day 5; 12 weeks after the end of the protocol
Scores in the functional test testing USN administered just before and after the rehabilitation protocol: CBS scale, evaluating the impact of neglect in 10 daily living activities (range 0-30)
Balance
时间窗: Day 0; Day 5; 12 weeks after the end of the protocol
Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)
次要结局
- Neuropsychological tests: Right vs. Left neglect(Day 5; 12 weeks after the end of the protocol)
- Functional Measures: Right vs. Left neglect(Day 5; 12 weeks after the end of the protocol)
- Disability Measures: Right vs. Left neglect(Day 5; 12 weeks after the end of the protocol)
- Balance: Right vs. Left neglect(Day 5; 12 weeks after the end of the protocol)
- Functional Measures: Follow-up(12 weeks after the end of the protocol)
- Balance: Follow-up(12 weeks after the end of the protocol)
研究者
Roberta Ronchi
Principal Investigator
University of Geneva, Switzerland