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

NCT ID: NCT07213180

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2023-09-25

Brief 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. 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.

Conditions

Post-stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier BONAVENTUR

Role: STUDY_DIRECTOR

CMRRF de Kerpape

Locations

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Ploemeur, Brittany Region, France

Countries

France

Other Identifiers

KER-2022_01

Identifier Type: OTHER

Identifier Source: secondary_id

2022-A01602-41

Identifier Type: -

Identifier Source: org_study_id