Fitness to Drive Among Stroke Patients

Sponsor

National Institute for Medical Rehabilitation, Hungary (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111989

Collaborator

Semmelweis University (Other)

100

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Driving Impaired	Behavioral: Neuropsychological testing Behavioral: On road test

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Driving test result [through study completion, an average of 2 years]
The driving instructor's classification (pass/fail)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute for Medical Rehabilitation	Budapest		Hungary	1121

Sponsors and Collaborators

National Institute for Medical Rehabilitation, Hungary
Semmelweis University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institute for Medical Rehabilitation, Hungary

ClinicalTrials.gov Identifier:

NCT06111989

Other Study ID Numbers:

IV/649-1/2022/EKU

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Institute for Medical Rehabilitation, Hungary

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 1, 2023