Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA) (RETROUVE)

RETROUVE : Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)

The RETROUVE study will provide healthcare professionals, patients and their families informations on the rate of return to driving in people who have suffered a stroke, and will provide a better understanding of the various factors that explain this return. This bi-centric study is being conducted in 2 parts: a retrospective part involving an analysis of medical records, and a prospective part involving a telephone questionnaire.

The main aim of this study is to assess the rate of return to driving in patients who have suffered a stroke, following an assessment of their fitness to drive. It will also aim to study the factors that explain a return to driving in post-stroke patients.

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to evaluate the rate of return to driving among stroke patients who underwent a formal fitness-to-drive assessment at the Kerpape CMRRF or Henry Gabrielle Hospital in 2019. Stroke patients may experience impairments in motor, cognitive, and executive functions, which can affect their ability to drive safely. The assessment involves a multidisciplinary evaluation including medical examination (vision, hearing, motor coordination), neuropsychological assessment (executive functions, attention, processing speed), and an on-road or simulator-based driving evaluation conducted by a driving instructor and occupational therapist.

The study consists of two phases:

Retrospective Analysis: Medical records of patients who underwent the driving assessment in 2019 will be reviewed. Collected variables include demographic characteristics (age, gender, education level), clinical data (stroke type, severity, comorbidities, medications affecting alertness), and driving assessment outcomes (favorable, unfavorable, or favorable with restrictions). The analysis will compare patients who were judged fit to drive with those who were judged unfit, in order to identify factors associated with a favorable driving outcome. Statistical methods include Chi-square tests, Student's t-tests or Wilcoxon tests depending on data distribution, and logistic regression to identify influential clinical, demographic, and driving-related factors.

Telephone Follow-Up: Approximately three years after the initial assessment, participants will be contacted by telephone to complete a follow-up questionnaire. The questionnaire evaluates current driving practices, limitations, perceived difficulties, and strategies adopted since the stroke. Telephone interviews are conducted by research staff and last approximately one hour.

All participants identified through medical records are informed about the study and their non-objection is recorded in the medical file. Data collection and analyses will adhere to the intention-to-treat principle. Missing data will be included in analyses, and any additional exploratory analyses will be clearly documented in the final report.

The study provides insight into long-term driving outcomes after stroke, the adaptation strategies patients implement, and the demographic and clinical factors influencing successful resumption of driving.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Brittany Region
      • Ploemeur, Brittany Region, France, 56275
        • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients who have undergone a driving driving assessment in 2019 at CMRRF de Kerpape or at Kerpape or Henry Gabrielle Hospital

Description

Inclusion Criteria:

  • Patient aged ≥ 18 years and ≤ 85
  • Having suffered a stroke (ischaemic and/or haemorrhagic)
  • Having completed a driving assessment in 2019 at one of the 2 centres participating in the study
  • Have not objected to taking part in the study

Exclusion Criteria:

  • Protected adults (guardianship)
  • Insufficient command of the French language
  • Deceased patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of return to driving after stroke
Time Frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Proportion of stroke patients assessed as fit to drive (favorable decision) by the multidisciplinary team and the registered physician, based on the 2019 driving assessments at Kerpape CMRRF or Henry Gabrielle Hospital.
From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Demographic factors associated with return to driving
Time Frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Age, gender, and education level of stroke patients, analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).
From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Clinical factors associated with return to driving
Time Frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Clinical characteristics of stroke patients (stroke type, lesion side and date, comorbidities) analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).
From date of stroke to date of driving assessment in 2019, assessed retrospectively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the maintenance of driving three years after a stroke and any changes in driving habits and/or practices, as well as driving habits and/or practices, as well as any new strategies brought about.
Time Frame: From end of 2019 assessment to date of telephone questionnaire in 2022, assessed prospectively.

This questionnaire will be sent to patients to gather information on their driving habits, limitations, fears and driving strategies.

The aim is not to focus on the problem of accidents in post-stroke patients. Rather, the aim is to find out whether they were able to maintain their driving activity despite the onset of a stroke, and to identify any driving difficulties they encountered. We also want to see whether they have changed their driving habits and/or implemented new strategies. The demographic and clinical information we obtain about them will also enable us to identify the most influential factors in the recovery process.

From end of 2019 assessment to date of telephone questionnaire in 2022, assessed prospectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Olivier BONAVENTUR, CMRRF de Kerpape

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

September 25, 2023

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Estimated)

October 8, 2025

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-A01602-41
  • KER-2022_01 (Other Identifier: CMRRF de Kerpape)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-stroke

Subscribe