StrokeROADTRIPNCT03977506
Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident (ROADTRIP)
A study testing On-road driving evaluation in people with Stroke, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- On-road driving evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2018to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- On-road driving evaluation
- Keywords
- driving capacity, cerebrovascular accident, grid
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-road driving evaluationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Behavoiral | Experimental | The evaluation will be realized on two different assessment grids during the test on the road Receives: Diagnostic Test: On-road driving evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: at 3 months
Secondary outcomes (3)
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
Measured: at 3 months
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
Measured: at day 1
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
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start19 Jun 2018
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Why it stopped: difficulty of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Bardoux, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977506
- Sponsor's protocol ID
- AOI 2016 BARDOUX
- Other IDs
- 2017-A02276-47
- Acronym
- ROADTRIP
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03977506
- Acronym / sponsor ID
- ROADTRIP / AOI 2016 BARDOUX
- Conditions
- Stroke
- Keywords
- driving capacity, cerebrovascular accident, grid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of recrutment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavoiral | Experimental | Diagnostic Test: On-road driving evaluationThe evaluation will be realized on two different assessment grids during the test on the road |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-road driving evaluationThe 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. | Diagnostic test | Behavoiral |
Primary outcome
The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
Time frame: at day 1
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).
The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
Time frame: at 1 month
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).
The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations)
Time frame: at 3 months
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).
3 secondary outcomes
The sensitivity to change
Time frame: at 3 months
The sensitivity to change
Time frame: at day 1
The sensitivity to change
Time frame: at 1 month
Results and safety
The study was stopped early (reason given: difficulty of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Bardoux principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-road driving evaluation in people with Stroke, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty of recrutment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The metrologic properties of the two evaluation grids (evaluation grids based on HAS and TRIP recommendations) (time frame: at day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.