Early Versus Delayed Treatment of Unilateral Neglect After Stroke

Study Overview
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Brief Summary
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'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?

Official Title
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Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial

Conditions
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Spatial Neglect After Stroke

Intervention / Treatment
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* Procedure: Prism adaptation with optical shift of 10 degrees.
* Procedure: Prism adaptation optical shift of 0 degrees.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female > 17 years of age stroke patients with clinical neglect, demonstrated by neglect tests Exclusion Criteria: severe ocular abnormalities not being able to perform prism adaptation or neglect tests

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early phase, experimental<br>Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke. | Procedure: Prism adaptation with optical shift of 10 degrees.<br>* Prism adaptation with optical shift of 10 degrees.<br>|
| Experimental: Delayed phase, experimental<br>Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. | Procedure: Prism adaptation with optical shift of 10 degrees.<br>* Prism adaptation with optical shift of 10 degrees.<br>|
| Placebo Comparator: Early phase, placebo<br>Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke. | Procedure: Prism adaptation optical shift of 0 degrees.<br>* Prism adaptation with optical shift of 0 degrees.<br>|
| Placebo Comparator: Delayed phase, placebo<br>Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke. | Procedure: Prism adaptation optical shift of 0 degrees.<br>* Prism adaptation with optical shift of 0 degrees.<br>|
| Experimental: Delayed phase postural, experimental<br>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. | Procedure: Prism adaptation with optical shift of 10 degrees.<br>* Prism adaptation with optical shift of 10 degrees.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of prism adaptation | 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. | Briefly after and 3 months after therapy cycle. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of well-being. | Questionnaires about emotional and functional status. Briefly after the Prism Adaptation (PA) sessions and 3 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. | Briefly after and 3 months after therapy cycle. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spatial neglect, stroke