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

NCT03977506 | Terminated

• 2 other identifiers: AOI 2016 BARDOUX2017-A02276-47
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

driving capacity; cerebrovascular accident; grid

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• The sensitivity to change

  at 3 months

• The sensitivity to change

  at day 1

• The sensitivity to change

  at 1 month

Study Arms (1)

Behavoiral

EXPERIMENTAL

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

Diagnostic Test: On-road driving evaluation

Interventions

On-road driving evaluation 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.

Behavoiral

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sylvie Bardoux

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: June 19, 2018
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

FR (1)