Spatial Neglect After Stroke Clinical Trial
Official title:
Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
| Verified date | November 2021 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
'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: 1. 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. 2. Which factors lead to a less favorable treatment outcome or to therapy resistance for PA? 3. Will the impact of PA be larger if postural factors are taken into account in the prism therapy?
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Rehabilitation Hospital "Hof ter Schelde" | Antwerp | |
| Belgium | Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation | Ghent | |
| Belgium | Ghent University Hospital, Department of Neurology | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Fund for Scientific Research, Flanders, Belgium |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |