NCT06111989

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

September 6, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

fitness to driveneuropsychologycognitivemachine learning

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.

Behavioral: Neuropsychological testingBehavioral: On road test

Interventions

The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator.

Stroke patients
On road testBEHAVIORAL

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.

Stroke patients

Eligibility Criteria

AgeUp to 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Gábor Fazekas, MD, PhD

    National Institute for Medical Rehabilitation, Hungary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gábor Fazekas, MD, PhD

CONTACT

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

Locations