Fitness to Drive Among Stroke Patients

NCT ID: NCT06111989

Last Updated: 2023-11-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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The goal of this observational study is to learn more about who can continue driving a car after a stroke. The focus of this study is on the relationship between cognitive abilities and fitness-to-drive.

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.

Detailed Description

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The relationship between cognitive abilities and driving skills is really complex. This study aims to introduce novel data analysing methods that can be used by medical professionals to decide whether the stroke patient is able to operate a vehicle safely or not.

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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Stroke Driving Impaired

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke patients

Patients who suffered ischemic or hemorrhagic stroke.

Neuropsychological testing

Intervention Type BEHAVIORAL

The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.

On road test

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 65 or younger
* ischemic or hemorrhagic stroke
* at least 6 months has passed after the stroke
* holds a valid driver's licence

Exclusion Criteria

* visual impairments (eg. visual field loss, nystagmus or diplopia)
* epilepsy
* serious movement disorders (eg. hemiplegia) that hider operating a car
* limb ataxia
* aphasia types that affect comprehension
* serious psychiatrical disorders
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role collaborator

National Institute for Medical Rehabilitation, Hungary

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Gábor Fazekas, MD, PhD

Role: CONTACT

+3613911946

Gábor Szabó

Role: CONTACT

+3613911900 ext. 1311

Facility Contacts

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Gábor Fazekas, MD habil PhD

Role: primary

+3613911946

Gábor Szabó

Role: backup

+3613911900 ext. 1311

Other Identifiers

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IV/649-1/2022/EKU

Identifier Type: -

Identifier Source: org_study_id

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