Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT03977506
Status:
TERMINATED
Last Update Posted:
2021-04-08
First Post:
2019-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident (ROADTRIP)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty of recrutment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROADTRIP
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A02276-47 | OTHER | ANSM | View |