- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07213180
- Original Trial
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brittany Region
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Ploemeur, Brittany Region, France, 56275
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of return to driving after stroke
Time Frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
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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.
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From date of stroke to date of driving assessment in 2019, assessed retrospectively.
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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).
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From date of stroke to date of driving assessment in 2019, assessed retrospectively.
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Clinical factors associated with return to driving
Time Frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
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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).
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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.
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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.
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Collaborators and Investigators
Investigators
- Study Director: Olivier BONAVENTUR, CMRRF de Kerpape
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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