Post-strokeRETROUVENCT07213180
Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)
An observational study of Post-stroke, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-stroke
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2022to 25 Sep 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients who have undergone a driving driving assessment in 2019 at CMRRF de Kerpape or at Kerpape or Henry Gabrielle Hospital
Who may be able to join
- 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
Who cannot join
- Protected adults (guardianship)
- Insufficient command of the French language
- Deceased patients
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Ploemeur, Brittany Region, 56275
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of return to driving after stroke
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.
Measured: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Demographic factors associated with return to driving
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).
Measured: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Clinical factors associated with return to driving
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).
Measured: From date of stroke to date of driving assessment in 2019, assessed retrospectively.
Secondary outcomes (1)
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.
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.
Measured: From end of 2019 assessment to date of telephone questionnaire in 2022, assessed prospectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start25 Nov 2022
- Primary completion25 Mar 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-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
- Cohort
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BONAVENTUR, Study director, CMRRF de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213180
- Sponsor's protocol ID
- 2022-A01602-41
- Other IDs
- KER-2022_01
- Acronym
- RETROUVE
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROUVE : Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)
- ClinicalTrials.gov ID
- NCT07213180
- Acronym / sponsor ID
- RETROUVE / 2022-A01602-41
- Conditions
- Post-stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 8 Oct 2025 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients who have undergone a driving driving assessment in 2019 at CMRRF de Kerpape or at Kerpape or Henry Gabrielle Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Protected adults (guardianship)
- Insufficient command of the French language
- Deceased patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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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.
Olivier BONAVENTUR study director
CMRRF de Kerpape
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 Post-stroke, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 8 Oct 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of return to driving after stroke (time frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.). The study lists 3 primary outcomes in all. 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 8 Oct 2025.