Early Versus Delayed Treatment of Unilateral Neglect After Stroke

NCT01341574 | Completed

• 2 other identifiers: 2011/161G.0906.10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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. 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. 2.Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
3. 3.Will the impact of PA be larger if postural factors are taken into account in the prism therapy?

Conditions

Spatial Neglect After Stroke

Keywords

spatial neglect; stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The degree of well-being.

  Briefly after and 3 months after therapy cycle.

Study Arms (5)

Early phase, experimental

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.

Delayed phase, experimental

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.

Early phase, placebo

PLACEBO COMPARATOR

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.

Delayed phase, placebo

PLACEBO COMPARATOR

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.

Delayed phase postural, experimental

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.

Interventions

Prism adaptation with optical shift of 10 degrees. PROCEDURE

Prism adaptation with optical shift of 10 degrees.

Delayed phase postural, experimental; Delayed phase, experimental; Early phase, experimental

Prism adaptation optical shift of 0 degrees. PROCEDURE

Prism adaptation with optical shift of 0 degrees.

Delayed phase, placebo; Early phase, placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female
• \> 17 years of age
• stroke patients with clinical neglect, demonstrated by neglect tests

You may not qualify if:

• severe ocular abnormalities
• not being able to perform prism adaptation or neglect tests

Sponsors & Collaborators

• University Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (3)

Rehabilitation Hospital "Hof ter Schelde"

Antwerp, Belgium

Location

Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation

Ghent, Belgium

Location

Ghent University Hospital, Department of Neurology

Ghent, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guy Vingerhoets, Ph.D., Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 25, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

BE (3)