Clinical trial NCT03977506: Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident (ROADTRIP)
Official title: Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident :Recommendations of the HAS (Hight Autority of Health in France) and Test Ride for Investigation Practical Fitness to Drive
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: driving capacity
cerebrovascular accident
grid
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the inclusive patients will benefit the first test of driving during 45minutes. The evaluation will be realized by a present occupational therapist and a neuropsychologist in the vehicle.

The second test on road will be for the part of included patients and will be made with the driving instructor and the therapist.

Then, the third test on road will be realized after sessions on driving simulator for the part of the patients requiring a re-entrainment.
Primary purpose: DIAGNOSTIC

Brief summary: Precise recommendations concerning the methods of evaluation for the resumption of the driving after a not evolutionary stroke were recommended recently by the High Authority of Health. These describe among others elements to be estimated during the test on the road, in the presence of the driving instructor who remains Gold standard.

However, no standardized assessment grid serving as decision-making tool is at present validated.

Actually the test made by the unit of evaluation of the automobile resumption of the university hospital on the road, in a car of apprenticeship with double pedals and in the presence of a professional binomial (driving instructor and occupational therapist) then validated by the opinion of the doctor of the service. The current standard is thus very subjective and lack of sensibility.

It is necessary to study the metrological properties of both available assessment grids (that established from the recommendations of the HAS and TRIP), none of them reached a level of validation enough in this population.

The TRIP is this day validated only at the elderly people. The hypothesis of the search is an insufficiency of TRIP to estimate the patients presenting aftereffects of cerebrovascular accident.

The main objective of this work is to validate the new assessment grid after a study of its metrological properties in the situation of the driving on the road.

Detailed description: The patients will benefit a medical consultation to estimate the possibility of inclusion in the study. During this consultation, the results of the neuropsychological and ophthalmological examinations will be explored and a specificity of the sensitive-driving deficits presented by the patient will be estimated to recommend the arrangements of necessary vehicle if necessary.

All the inclusive patients will benefit then the first test of driving in "ecological" situation accompanied by a lasting driving instructor during 45minutes. The evaluation will be realized by a present occupational therapist and a neuropsychologist in the vehicle, on two different assessment grids.

The second test on road will be for the part of included patients and will be made with the driving instructor and the therapist.

Then, the third test on road will be realized after sessions on driving simulator for the part of the patients requiring a re-entrainment.

Eligibility criteria: Inclusion Criteria:

* 18 Years to 80 Years
* Cognitive and/or sensitive-motor disorders after a cerebrovascular accident
* Candidate for resumption of driving on the road and having to pass an aptitude test
* French legal protection

Exclusion Criteria:

* Contraindications for resumption of driving on the road (visual field amputation, binocular visual acuity less than 5/10; cognitive impairment not compatible with driving; other medical contraindication).
* Protected populations not concerned by the study (guardianship, curatorship, deprived of the freedoms, safeguarding of justice).

Primary outcomes:
measure: The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
timeFrame: at day 1
measure: The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
timeFrame: at 1 month
measure: The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
timeFrame: at 3 months
Secondary outcomes:
measure: The sensitivity to change
timeFrame: at 3 months
measure: The sensitivity to change
timeFrame: at day 1
measure: The sensitivity to change
timeFrame: at 1 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sylvie Bardoux
role: PRINCIPAL_INVESTIGATOR
References: