Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-03-01
2024-12-31
Brief Summary
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Participants will be asked to perform an extended neuropsychological testing and a real life on-road test, conducted by a professional driving instructor. Feedback will be given to the participants on request.
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Detailed Description
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The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator. This part will be approximately 2 hours. Since the first part is really tiresome, the test driving will be on an other day. The driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety.
Who can participate in the study:
* Aged 65 or younger
* Holds a driving licence
* Had an ischemic or hemorrhagic stroke
* Has sufficient physical abilities to operate a car
* Does not have certain medical conditions such epilepsy
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Stroke patients
Patients who suffered ischemic or hemorrhagic stroke.
Neuropsychological testing
The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.
On road test
The driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety.
Interventions
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Neuropsychological testing
The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.
On road test
The driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety.
Eligibility Criteria
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Inclusion Criteria
* ischemic or hemorrhagic stroke
* at least 6 months has passed after the stroke
* holds a valid driver's licence
Exclusion Criteria
* epilepsy
* serious movement disorders (eg. hemiplegia) that hider operating a car
* limb ataxia
* aphasia types that affect comprehension
* serious psychiatrical disorders
65 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
National Institute for Medical Rehabilitation, Hungary
OTHER_GOV
Responsible Party
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Principal Investigators
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Gábor Fazekas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Medical Rehabilitation, Hungary
Locations
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National Institute for Medical Rehabilitation
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IV/649-1/2022/EKU
Identifier Type: -
Identifier Source: org_study_id
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