Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- effect of prism adaptation
研究概览
简要总结
'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.
One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.
Research questions:
- Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
- Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
- Will the impact of PA be larger if postural factors are taken into account in the prism therapy?
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
- Single (Participant)
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
- •male or female
- •> 17 years of age
- •stroke patients with clinical neglect, demonstrated by neglect tests
排除标准
- •severe ocular abnormalities
- •not being able to perform prism adaptation or neglect tests
研究组 & 干预措施
Early phase, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke.
干预措施: Prism adaptation with optical shift of 10 degrees. (Procedure)
Delayed phase, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke.
干预措施: Prism adaptation with optical shift of 10 degrees. (Procedure)
Early phase, placebo
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke.
干预措施: Prism adaptation optical shift of 0 degrees. (Procedure)
Delayed phase, placebo
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke.
干预措施: Prism adaptation optical shift of 0 degrees. (Procedure)
Delayed phase postural, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. In this group, postural aspects are taken into account.
干预措施: Prism adaptation with optical shift of 10 degrees. (Procedure)
结局指标
主要结局
effect of prism adaptation
时间窗: Briefly after and 3 months after therapy cycle.
The effect of Prism Adaptation (PA) will be evaluated regarding the degree of neglect, postural control and cerebral functioning, briefly after the therapy cycle and 3 months later. Briefly after the PA sessions and three months later, in patients in the early as well as the delayed phase after stroke: * early: PA starting within 4 weeks after stroke; * delayed: PA starting 2 months after stroke; * OR divided in an early and a delayed group according to the median.
次要结局
- The degree of well-being.(Briefly after and 3 months after therapy cycle.)