Fitness to Drive Among Stroke Patients

October 26, 2023 updated by: National Institute for Medical Rehabilitation, Hungary

To Drive or Not to Drive? A Machine Learning Data Analysis Approach Among Stroke Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary, 1121
        • Recruiting
        • National Institute for Medical Rehabilitation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke patients
Patients who suffered ischemic or hemorrhagic stroke.
Behavioral: Neuropsychological testing
The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Driving test result
Time Frame: through study completion, an average of 2 years
The driving instructor's classification (pass/fail)
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Medical Rehabilitation, Hungary

Collaborators

Semmelweis University

Investigators

  • Principal Investigator: Gábor Fazekas, MD, PhD, National Institute for Medical Rehabilitation, Hungary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV/649-1/2022/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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