Fitness to Drive Among Stroke Patients
To Drive or Not to Drive? A Machine Learning Data Analysis Approach Among Stroke Patients
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 1, 2023
October 1, 2023
2.8 years
September 6, 2023
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Driving test result
The driving instructor's classification (pass/fail)
through study completion, an average of 2 years
Study Arms (1)
Stroke patients
Patients who suffered ischemic or hemorrhagic stroke.
Interventions
The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.
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.
Eligibility Criteria
Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary
You may qualify if:
- or younger
- ischemic or hemorrhagic stroke
- at least 6 months has passed after the stroke
- holds a valid driver's licence
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute for Medical Rehabilitation
Budapest, 1121, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gábor Fazekas, MD, PhD
National Institute for Medical Rehabilitation, Hungary
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2023
First Posted
November 1, 2023
Study Start
March 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
November 1, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share