The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
NCT ID: NCT01617343
Last Updated: 2014-04-08
Study Results
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Basic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2012-08-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual care
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
No interventions assigned to this group
HEP-OKS
hemifield eye patching (HEP) + optokinetic stimulation (OKS)
Patients in this arm will wear standard spectacle frames containing noncorrective lenses to which right half-field patches are attached (hemifield eye patching, HEP). In case of patients already wearing prescribed glasses, the patches will be attached to their own glasses. The glasses will be worn all-day for the duration of the treatment phase (seven days) and only be removed for sleeping and face cleaning as well as for the duration of the daily OKS treatment sessions.
Furthermore these patients will receive daily sessions (20 minutes) of optokinetic stimulation (OKS). Therefore patients will be seated in front of a widescreen monitor, watching a black background with a pattern of various objects (size 1°), which coherently and continuously move to the left at a velocity of 10 °/s.
Interventions
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hemifield eye patching (HEP) + optokinetic stimulation (OKS)
Patients in this arm will wear standard spectacle frames containing noncorrective lenses to which right half-field patches are attached (hemifield eye patching, HEP). In case of patients already wearing prescribed glasses, the patches will be attached to their own glasses. The glasses will be worn all-day for the duration of the treatment phase (seven days) and only be removed for sleeping and face cleaning as well as for the duration of the daily OKS treatment sessions.
Furthermore these patients will receive daily sessions (20 minutes) of optokinetic stimulation (OKS). Therefore patients will be seated in front of a widescreen monitor, watching a black background with a pattern of various objects (size 1°), which coherently and continuously move to the left at a velocity of 10 °/s.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-existing neurodegenerative disease
* Inability to give informed consent
18 Years
90 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
University of Luebeck
OTHER
Responsible Party
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Bjoern Machner
MD, Principal Investigator
Principal Investigators
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Bjoern Machner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Luebeck
Locations
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University of Luebeck, Dept. of Neurology
Lübeck, Schleswig-Holstein, Germany
Countries
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References
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Machner B, Konemund I, Sprenger A, von der Gablentz J, Helmchen C. Randomized controlled trial on hemifield eye patching and optokinetic stimulation in acute spatial neglect. Stroke. 2014 Aug;45(8):2465-8. doi: 10.1161/STROKEAHA.114.006059. Epub 2014 Jun 12.
Other Identifiers
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HEP-OKS-01
Identifier Type: -
Identifier Source: org_study_id
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