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Fitness to Drive Among Stroke Patients

N

National Institute for Medical Rehabilitation, Hungary

Status

Enrolling

Conditions

Stroke
Driving Impaired

Treatments

Behavioral: Neuropsychological testing
Behavioral: On road test

Study type

Observational

Funder types

Other

Identifiers

NCT06111989
IV/649-1/2022/EKU

Details and patient eligibility

About

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.

Full description

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

Enrollment

100 estimated patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Stroke patients
Description:
Patients who suffered ischemic or hemorrhagic stroke.
Treatment:
Behavioral: On road test
Behavioral: Neuropsychological testing

Trial contacts and locations

1

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Central trial contact

Gábor Fazekas, MD, PhD; Gábor Szabó

Data sourced from clinicaltrials.gov

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