Early Versus Delayed Treatment of Unilateral Neglect After Stroke
This study is currently recruiting participants.
Verified April 2012 by University Ghent
Sponsor:
University Ghent
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01341574
First received: April 18, 2011
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
'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?
| Condition | Intervention |
|---|---|
|
Spatial Neglect After Stroke |
Procedure: Prism adaptation with optical shift of 10 degrees. Procedure: Prism adaptation optical shift of 0 degrees. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial |
Further study details as provided by University Ghent:
Primary Outcome Measures:
- effect of prism adaptation [ Time Frame: Briefly after and 3 months after therapy cycle. ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- The degree of well-being. [ Time Frame: Briefly after and 3 months after therapy cycle. ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early phase, experimental
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.
Prism adaptation with optical shift of 10 degrees.
|
|
Experimental: Delayed phase, experimental
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.
Prism adaptation with optical shift of 10 degrees.
|
|
Placebo Comparator: Early phase, placebo
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.
Prism adaptation with optical shift of 0 degrees.
|
|
Placebo Comparator: Delayed phase, placebo
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.
Prism adaptation with optical shift of 0 degrees.
|
|
Experimental: 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.
|
Procedure: Prism adaptation with optical shift of 10 degrees.
Prism adaptation with optical shift of 10 degrees.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341574
Contacts
| Contact: Nathalie Vaes, Ph.D. student | Nathalie.Vaes@ugent.be | |
| Contact: Guy Vingerhoets, Ph.D. | Guy.Vingerhoets@ugent.be |
Locations
| Belgium | |
| Rehabilitation Hospital "Hof ter Schelde" | Recruiting |
| Antwerp, Belgium | |
| Contact: Christophe Lafosse, Ph.D Christophe.Lafosse@hofterschelde.be | |
| Principal Investigator: Christophe Lafosse, Ph.D. | |
| Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation | Recruiting |
| Ghent, Belgium | |
| Contact: Kristine Oostra, M.D. Kristine.Oostra@uzgent.be | |
| Principal Investigator: Kristine Oostra, M.D. | |
| Ghent University Hospital, Department of Neurology | Recruiting |
| Ghent, Belgium | |
| Contact: Dimitri Hemelsoet, M.D. Dimitri.Hemelsoet@ugent.be | |
| Principal Investigator: Dimitri Hemelsoet, M.D. | |
Sponsors and Collaborators
University Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
| Principal Investigator: | Guy Vingerhoets, Ph.D. , Professor | University Ghent |
More Information
No publications provided
| Responsible Party: | University Ghent |
| ClinicalTrials.gov Identifier: | NCT01341574 History of Changes |
| Other Study ID Numbers: | 2011/161, G.0906.10 |
| Study First Received: | April 18, 2011 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Ghent:
|
spatial neglect stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Perceptual Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013