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Promote Awareness of the Driving Abilities of Post-stroke Patients. (AUTOCAM-AVC)

C

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Status

Enrolling

Conditions

Cerebrovascular Accident

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06530134
2020-A03377-32

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

With video feedback
Experimental group
Description:
Activation of on-board cameras during driving situation.
Treatment:
Other: Driving situation and video feedback
Without video feedback
Other group
Description:
Non-Activation of on-board cameras during driving situation.
Treatment:
Other: Driving situation and usual recommendations (without video feedback)

Trial contacts and locations

1

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Central trial contact

Pauline Coignard, Doctor; Marie-Caroline Delebecque, CRA

Data sourced from clinicaltrials.gov

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