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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Driving situation and video feedback

    Other intervention

    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.

  • Driving situation and usual recommendations (without video feedback)

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: With video feedbackExperimental treatment 1 intervention
Group B: Without video feedbackOther 1 intervention

Trial outcomes

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.

Time frame
Day 0

Secondary outcomes

1

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.

The score of question 4 of the "Q final-pro" questionnaire will be compared to question 7 of the "Q final-pa" questionnaire (with or without feedback depending on the arm). The differences between the two opinions (Patient Opinions-Professional Opinions) on all the evaluations will allow to establish a score "of concordance of the opinions of rework". A score equal to zero means that the opinions are the same between the patient and the professionals (best outcome), a positive or negative score means that the opinions are divergent. The closer the score is to zero, the better the result. The same process will be followed with the control group that did not receive video feedback in order to compare the concordance scores of the rework notices between the two arms.

Time frame
Day 0
2

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

Study of the concordance between the total score of the TRIP (Test Ride for Investigating Practical Fitness to Drive) grid (Qpost-cond-trip) of the driving teacher and that of the occupational therapist (score/100) Calcul of a correlation coefficient : the higher the coefficient, the more consistent the assessments between the 2 professionals are (better outcome).

Time frame
Day 0
3

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

Study of the concordance between the total score of the interview grid (Qentr-pro) of the driving teacher and that of the occupational therapist (score/28). Calcul of a correlation coefficient : the higher the coefficient, the more consistent the assessments between the 2 professionals are (better outcome).

Time frame
Day 0
4

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

• \[MOCA test /30 score\] PFO compared to PUO (MOCA : Montreal Cognitive Assessment)

Time frame
Day 0

Other outcomes

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