StrokeNCT06111989
Fitness to Drive Among Stroke Patients
An observational study of Stroke and Driving Impaired, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Stroke, Driving Impaired
- What is being tested?
- Neuropsychological testing and On road test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Mar 2022to 31 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary
Who may be able to join
- 65 or younger
- ischemic or hemorrhagic stroke
- at least 6 months has passed after the stroke
- holds a valid driver's licence
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
National Institute for Medical Rehabilitation
Budapest, 1121
Gábor Fazekas, MD habil PhD, +3613911946, fazekas.gabor@omint.hu
Gábor Szabó, +3613911900 ext. 1311, szabo.gabor@omint.hu
About this study
Official title: 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.
Read the 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
- Conditions
- Stroke, Driving Impaired
- Being tested
- Neuropsychological testing, On road test
- Keywords
- fitness to drive, neuropsychology, cognitive, machine learning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.
On road testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Patients who suffered ischemic or hemorrhagic stroke. Receives: Behavioral: Neuropsychological testing; Behavioral: On road test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving test result
The driving instructor's classification (pass/fail)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Rehabilitation, Hungary
- Sponsor type
- Other government
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor
- Investigators
- Gábor Fazekas, MD, PhD, Principal investigator, National Institute for Medical Rehabilitation, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111989
- Sponsor's protocol ID
- IV/649-1/2022/EKU
- Status last verified
- Oct 2023
- First submitted
- 6 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Drive or Not to Drive? A Machine Learning Data Analysis Approach Among Stroke Patients
- ClinicalTrials.gov ID
- NCT06111989
- Acronym / sponsor ID
- IV/649-1/2022/EKU
- Conditions
- Stroke, Driving Impaired
- Keywords
- fitness to drive, neuropsychology, cognitive, machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute for Medical Rehabilitation, HungaryOther government
- Collaborators
- Semmelweis University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Behavioral: Neuropsychological testing, Behavioral: On road testPatients who suffered ischemic or hemorrhagic stroke. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary
Key inclusion criteria (4 listed)
- 65 or younger
- ischemic or hemorrhagic stroke
- at least 6 months has passed after the stroke
- holds a valid driver's licence
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingThe neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator. | Behavioural | Stroke patients |
| On road testThe 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. | Behavioural | Stroke patients |
Primary outcome
Driving test result
Time frame: through study completion, an average of 2 years
The driving instructor's classification (pass/fail)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gábor Fazekas, MD, PhD principal investigator
National Institute for Medical Rehabilitation, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Driving Impaired, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gábor Fazekas, MD, PhD (+3613911946, fazekas.gabor@omint.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving test result (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.