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

NCT ID: NCT06530134

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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With video feedback

Activation of on-board cameras during driving situation.

Group Type EXPERIMENTAL

Driving situation and video feedback

Intervention Type 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.

Without video feedback

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

Group Type OTHER

Driving situation and usual recommendations (without video feedback)

Intervention Type 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.

Interventions

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Driving situation and video feedback

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.

Intervention Type OTHER

Driving situation and usual recommendations (without video feedback)

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Gustave Eiffel

OTHER

Sponsor Role collaborator

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pauline Coignard, Doctor

Role: PRINCIPAL_INVESTIGATOR

CMRRF de Kerpape

Locations

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CMRRF de Kerpape

Ploemeur, Brittany Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pauline Coignard, Doctor

Role: CONTACT

0297826179 ext. +33

Marie-Caroline Delebecque, CRA

Role: CONTACT

0297826293 ext. +33

Facility Contacts

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Marie-Caroline de Kerpape, CRA

Role: primary

0297826293 ext. +33

Other Identifiers

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2020-A03377-32

Identifier Type: -

Identifier Source: org_study_id

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