Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident (ROADTRIP)

NCT ID: NCT03977506

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2021-04-02

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Behavoiral

The evaluation will be realized on two different assessment grids during the test on the road

Group Type: EXPERIMENTAL

On-road driving evaluation

Intervention Type: DIAGNOSTIC_TEST

The data assessed during the road test from the two assessment grids (recommendations of the HAS and Test ride for investigation practical fitness to drive) :

road position, vehicle control, track management, safety distances, speed, visual behavior, traffic signs, vehicle overtaking, anticipatory reactions and capabilities adaptation, attentional skills, decision-making, communication with other road users, assessment of specific situations such as insertion on a 2x2 lane, mechanical management and general impressions.

Interventions

On-road driving evaluation

The data assessed during the road test from the two assessment grids (recommendations of the HAS and Test ride for investigation practical fitness to drive) :

road position, vehicle control, track management, safety distances, speed, visual behavior, traffic signs, vehicle overtaking, anticipatory reactions and capabilities adaptation, attentional skills, decision-making, communication with other road users, assessment of specific situations such as insertion on a 2x2 lane, mechanical management and general impressions.

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Bardoux

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2017-A02276-47

Identifier Type: OTHER

Identifier Source: secondary_id

AOI 2016 BARDOUX

Identifier Type: -

Identifier Source: org_study_id