Promote Awareness of the Driving Abilities of Post-stroke Patients.

NCT06530134 | Recruiting

• 1 other identifier: 2020-A03377-32
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

post-stroke

Outcome Measures

Primary Outcomes (1)

• Awareness of driving behavior.

  This criterion will be measured using the difference between patient's and the professional's scores from the interview with the situation analyzes. If the difference between the patient's score and that of the professionals is close to zero, it means that the patient correctly self-estimates their driving abilities. If the difference is positive, it means the patient overestimates their abilities. If the difference is negative, it means the patient underestimates their abilities. The professionals score is the mean of the score of each professional (occupational therapist and driving instructor) The patient fills out the questionnaire before and after the interview. The two professionals fill out the questionnaire once, before the interview. This score of driving behavior awareness after the interview will be compared to that before the interview, reflecting any potiential change in awareness following the interview.

  Day 0

Secondary Outcomes (13)

• 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.

  Day 0

• The concordance between the opinion of the driving teacher and the occupational therapist after the on-road test

  Day 0

• The concordance between the opinion of the driving teacher and the occupational therapist for the interview grid

  Day 0

• Compare the MOCA score between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)

  Day 0

• Compare the score of Rey's Figure between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)

  Day 0

Study Arms (2)

With video feedback

EXPERIMENTAL

Activation of on-board cameras during driving situation.

Other: Driving situation and video feedback

Without video feedback

OTHER

Non-Activation of on-board cameras during driving situation.

Other: Driving situation and usual recommendations (without video feedback)

Interventions

Driving situation and video feedback OTHER

At the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation using video feedback.

With video feedback

Driving situation and usual recommendations (without video feedback) OTHER

At the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation without video feedback, according to the usual recommendations. Comparison of responses to all questionnaires and interview grids sent before and after driving, to patients and professionals will determine whether video feedback promotes awareness of the difficulties of driving post-stroke patients.

Without video feedback

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Insufficient command of the French language
• Protected adults (curators)
• Pregnancy declared
• Being unable to issue their consent

Sponsors & Collaborators

• Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape: lead
• University Gustave Eiffel: collaborator

Study Sites (1)

CMRRF de Kerpape

Ploemeur, Brittany Region, 56270, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pauline Coignard, Doctor

  CMRRF de Kerpape

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Coignard, Doctor

CONTACT

0297826179; pauline.coignard@vyv3.fr

Marie-Caroline Delebecque, CRA

CONTACT

0297826293; kerpape.arc@vyv3.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: July 31, 2024
• Study Start: October 12, 2021
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)