Stroke Clinical Trial
— ROADTRIPOfficial 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
Verified date | April 2021 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | April 2, 2021 |
Est. primary completion date | April 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations) | Acceptability will be based on the calculation of missing data at the level of each item and for the overall score of the study grids. Internal Consistency will be determined through Cronbach's alpha coefficient. Internal validity will be determined by study of correlation between the domains composing of the HAS and TRIP grids. Reproducibility .the Kappa concordance correlation coefficient will be used to determine the test-retest reliability. Internal validity will be determined by study of the correlation between of HAS and TRIP grids. External validity will be based on the study of correlations of scores from HAS and TRIP grids (Pearson or Spearman according to statistical distribution). | at day 1 | |
Primary | The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations) | Acceptability will be based on the calculation of missing data at the level of each item and for the overall score of the study grids. Internal Consistency will be determined through Cronbach's alpha coefficient. Internal validity will be determined by study of correlation between the domains composing of the HAS and TRIP grids. Reproducibility .the Kappa concordance correlation coefficient will be used to determine the test-retest reliability. Internal validity will be determined by study of the correlation between of HAS and TRIP grids. External validity will be based on the study of correlations of scores from HAS and TRIP grids (Pearson or Spearman according to statistical distribution). | at 1 month | |
Primary | The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations) | Acceptability will be based on the calculation of missing data at the level of each item and for the overall score of the study grids. Internal Consistency will be determined through Cronbach's alpha coefficient. Internal validity will be determined by study of correlation between the domains composing of the HAS and TRIP grids. Reproducibility .the Kappa concordance correlation coefficient will be used to determine the test-retest reliability. Internal validity will be determined by study of the correlation between of HAS and TRIP grids. External validity will be based on the study of correlations of scores from HAS and TRIP grids (Pearson or Spearman according to statistical distribution). | at 3 months | |
Secondary | The sensitivity to change | The ability of the instrument to highlight a variation deemed relevant by experts, will be explored. The analyses described above for the tests-retest comparisons analyses will be re-implemented, the calculation of the effect-size will be performed for each grid | at 3 months | |
Secondary | The sensitivity to change | The ability of the instrument to highlight a variation deemed relevant by experts, will be explored. The analyses described above for the tests-retest comparisons analyses will be re-implemented, the calculation of the effect-size will be performed for each grid | at day 1 | |
Secondary | The sensitivity to change | The ability of the instrument to highlight a variation deemed relevant by experts, will be explored. The analyses described above for the tests-retest comparisons analyses will be re-implemented, the calculation of the effect-size will be performed for each grid | at 1 month |
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