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Early Versus Delayed Treatment of Unilateral Neglect After Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01341574
Enrollment
100
Registered
2011-04-25
Start date
2011-08-31
Completion date
2015-12-31
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spatial Neglect After Stroke

Keywords

spatial neglect, stroke

Brief summary

'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?

Interventions

PROCEDUREPrism adaptation with optical shift of 10 degrees.

Prism adaptation with optical shift of 10 degrees.

PROCEDUREPrism adaptation optical shift of 0 degrees.

Prism adaptation with optical shift of 0 degrees.

Sponsors

Fund for Scientific Research, Flanders, Belgium
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effect of prism adaptationBriefly 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.

Secondary

MeasureTime frameDescription
The degree of well-being.Briefly after and 3 months after therapy cycle.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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026