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

'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?

Study Overview

• Status: Completed
• Conditions: Spatial Neglect After Stroke
• Intervention / Treatment: Procedure: Prism adaptation with optical shift of 10 degrees.; Procedure: Prism adaptation optical shift of 0 degrees.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Rehabilitation Hospital "Hof ter Schelde"
  • Ghent, Belgium
    • Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation
  • Ghent, Belgium
    • Ghent University Hospital, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Guy Vingerhoets, Ph.D., Professor, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: stroke; spatial neglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Stroke; Perceptual Disorders
• Other Study ID Numbers: 2011/161; G.0906.10 (Other Grant/Funding Number: FWO)