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The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients

U

University of Luebeck

Status and phase

Completed
Phase 3

Conditions

Spatial Neglect
Cerebral Stroke

Treatments

Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)

Study type

Interventional

Funder types

Other

Identifiers

NCT01617343
HEP-OKS-01

Details and patient eligibility

About

Spatial neglect represents one of the major cognitive disorders following stroke. Patients patients fail to be aware of objects or people to their left and orientate instead to their right side. Enduring neglect has been found to be a poor prognostic indicator for functional independence following stroke. Despite some promising experimental accounts there are no established treatments for this condition.

The aim of this study is to test whether a combined treatment with hemifield eye patching (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve functional outcome in patients with hemispatial neglect following stroke.

The investigators hypothesise that the treatment with HEP and OKS will lead to a greater reduction of neglect scoring in the neglect test battery as well as a greater improvement in functional independence scores as compared to the spontaneous clinical course of the usual-care control group.

Full description

To specify, this study should answer the following main question: Does the daily wearing of hemifield eye patches over a period of 1 week in combination with daily sessions of optokinetic stimulation lead to a significant reduction of neglect behaviour as measured by total scores in a paper-and-pencil neglect test battery and/or an improvement in functional independence scores (Catherine-Bergego-Scale, Barthel Index) in a cohort of stroke patients with acute hemispatial neglect as compared to the spontaneous course of the disease in a control patient group without a neglect-specific treatment?

Enrollment

23 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Right hemisphere stroke
  • Spatial neglect as determined by pathological scores in at least two tests of a neglect test battery (Azouvi et al., JNNP, 2004)
  • Age > 18 years old
  • Informed consent signature

Exclusion criteria

  • Bilateral or previous unilateral stroke lesions
  • Pre-existing neurodegenerative disease
  • Inability to give informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

23 participants in 2 patient groups

Usual care
No Intervention group
Description:
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
HEP-OKS
Experimental group
Treatment:
Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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