Skip to main content
OpenTrials
Completed

NCT Number: NCT01341574

Early Versus Delayed Treatment of Unilateral Neglect After Stroke

'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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spatial Neglect After Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital "Hof ter Schelde", Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prism adaptation with optical shift of 10 degrees.

Procedure

Prism adaptation with optical shift of 10 degrees.

Prism adaptation optical shift of 0 degrees.

Procedure

Prism adaptation with optical shift of 0 degrees.

Primary outcomes

  1. effect of prism adaptation

    Time frame: 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.

Secondary outcomes

  1. The degree of well-being.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2011
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.