Fitness to Drive Among Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111989
• Other study ID #: IV/649-1/2022/EKU
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: National Institute for Medical Rehabilitation, Hungary
• Contact: Gábor Fazekas, MD, PhD
• Phone: +3613911946
• Email: fazekas.gabor[@]omint.hu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Driving Impaired
• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hungary	National Institute for Medical Rehabilitation	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Medical Rehabilitation, Hungary	Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving test result	The driving instructor's classification (pass/fail)	through study completion, an average of 2 years