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Early Versus Delayed Treatment of Unilateral Neglect After Stroke

Primary Purpose

Spatial Neglect After Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Prism adaptation with optical shift of 10 degrees.
Prism adaptation optical shift of 0 degrees.
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spatial Neglect After Stroke focused on measuring spatial neglect, stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

Early phase, experimental

Delayed phase, experimental

Early phase, placebo

Delayed phase, placebo

Delayed phase postural, experimental

Arm Description

Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke.

Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke.

Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke.

Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 18, 2011
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT01341574
Brief Title
Early Versus Delayed Treatment of Unilateral Neglect After Stroke
Official Title
Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect After Stroke
Keywords
spatial neglect, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early phase, experimental
Arm Type
Experimental
Arm Description
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke.
Arm Title
Delayed phase, experimental
Arm Type
Experimental
Arm Description
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke.
Arm Title
Early phase, placebo
Arm Type
Placebo Comparator
Arm Description
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke.
Arm Title
Delayed phase, placebo
Arm Type
Placebo Comparator
Arm Description
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke.
Arm Title
Delayed phase postural, experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prism adaptation with optical shift of 10 degrees.
Intervention Description
Prism adaptation with optical shift of 10 degrees.
Intervention Type
Procedure
Intervention Name(s)
Prism adaptation optical shift of 0 degrees.
Intervention Description
Prism adaptation with optical shift of 0 degrees.
Primary Outcome Measure Information:
Title
effect of prism adaptation
Description
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.
Time Frame
Briefly after and 3 months after therapy cycle.
Secondary Outcome Measure Information:
Title
The degree of well-being.
Description
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.
Time Frame
Briefly after and 3 months after therapy cycle.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Vingerhoets, Ph.D., Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital "Hof ter Schelde"
City
Antwerp
Country
Belgium
Facility Name
Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation
City
Ghent
Country
Belgium
Facility Name
Ghent University Hospital, Department of Neurology
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Early Versus Delayed Treatment of Unilateral Neglect After Stroke

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