Clinical trial NCT06530134: Promote Awareness of the Driving Abilities of Post-stroke Patients.
Official title: Promote Awareness of the Driving Abilities of Post-stroke Patients: Interest of On-board Cameras and Self-assessment Questionnaires During a Driving Situation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: post-stroke
Lead sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Sponsor class: OTHER
Collaborators: name: University Gustave Eiffel
First posted: 2024-07-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is part of a Research Involving the Human Person of the interventional with minimal risks and constraints type (RIPH2).This is a prospective, monocentric, comparative, randomized and controlled study.
Primary purpose: OTHER

Brief summary: Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities.

This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams.

The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.


Eligibility criteria: Inclusion Criteria:

* Stroke (ischemic and / or hemorrhagic) between 1 month and 6 months
* Holder of a driving license for more than 3 years
* No resumption of driving
* MoCA score ≥ 10
* Affiliation to a social security scheme or beneficiary of such a scheme
* Having signed a free, informed and written consent
* Medically stable

Exclusion Criteria:

* Aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision \<6/10, visual field \<120 ° in binocular, \<50 ° to the right and to the left beyond the central point, \<30 ° vertically.
* History of neurological disease responsible for cognitive impairment
* Need for vehicle modifications except automatic gearbox
* Subject being in a period of exclusion from another protocol
* Insufficient command of the French language
* Protected adults (curators)
* Pregnancy declared
* Being unable to issue their consent

Primary outcomes:
measure: Awareness of driving behavior.
timeFrame: Day 0
Secondary outcomes:
measure: The concordance between the opinion of the two professionals (driving instructor and occupational therapist) and that of the patient about returning to driving, then compare this concordance between the two arms.
timeFrame: Day 0
measure: The concordance between the opinion of the driving teacher and the occupational therapist after the on-road test
timeFrame: Day 0
measure: The concordance between the opinion of the driving teacher and the occupational therapist for the interview grid
timeFrame: Day 0
measure: Compare the MOCA score between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Compare the score of Rey's Figure between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Compare the score of Bell Test between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Compare the attentional performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Compare the information processing speed between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Compare the working memory performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
timeFrame: Day 0
measure: Links between cognitive performance and the awareness score of driving skills.
timeFrame: Day 0
measure: Links between awareness of cognitive impairment and awareness of driving skills.
timeFrame: Day 0
measure: Become patients at 6 months
timeFrame: At 6 months
measure: Acceptability of the video device by professionals and patients
timeFrame: Day 0
Other outcomes:
Locations:
city: Ploemeur
country: France
facility: CMRRF de Kerpape
state: Bretagne
Study officials:
affiliation: CMRRF de Kerpape
name: Pauline Coignard, Doctor
role: PRINCIPAL_INVESTIGATOR
References: