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

U

University Hospital, Clermont-Ferrand

Status

Terminated

Conditions

Stroke

Treatments

Diagnostic Test: On-road driving evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03977506
AOI 2016 BARDOUX
2017-A02276-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Behavoiral
Experimental group
Description:
The evaluation will be realized on two different assessment grids during the test on the road
Treatment:
Diagnostic Test: On-road driving evaluation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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