Cerebrovascular AccidentAUTOCAM-AVCNCT06530134
Promote Awareness of the Driving Abilities of Post-stroke Patients.
A study testing Driving situation and video feedback and Driving situation and usual recommendations (without video feedback) in people with Cerebrovascular Accident, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial summary
Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Driving situation and video feedback and Driving situation and usual recommendations (without video feedback)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to Nov 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke (ischemic and / or hemorrhagic) between 1 month and 6 months
- Holder of a driving license for more than 3 years
- No resumption of driving
- MoCA score ≥ 10
- Affiliation to a social security scheme or beneficiary of such a scheme
- Having signed a free, informed and written consent
- Medically stable
Who cannot join
- Aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision <6/10, visual field <120 ° in binocular, <50 ° to the right and to the left beyond the central point, <30 ° vertically.
- History of neurological disease responsible for cognitive impairment
- Need for vehicle modifications except automatic gearbox
- Subject being in a period of exclusion from another protocol
- Insufficient command of the French language
- Protected adults (curators)
- Pregnancy declared
- Being unable to issue their consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CMRRF de Kerpape
Ploemeur, Brittany Region, 56270
Marie-Caroline de Kerpape, CRA, 0297826293 ext. +33, kerpape.arc@vyv3.fr
Pauline Coignard, Doctor
About this study
Official title: Promote Awareness of the Driving Abilities of Post-stroke Patients: Interest of On-board Cameras and Self-assessment Questionnaires During a Driving Situation.
Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities.
This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams.
The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.
- Conditions
- Cerebrovascular Accident
- Being tested
- Driving situation and video feedback, Driving situation and usual recommendations (without video feedback)
- Keywords
- post-stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving situation and video feedbackOther
At the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation using video feedback.
Driving situation and usual recommendations (without video feedback)Other
At the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation without video feedback, according to the usual recommendations.
Comparison of responses to all questionnaires and interview grids sent before and after driving, to patients and professionals will determine whether video feedback promotes awareness of the difficulties of driving post-stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| With video feedback | Experimental | Activation of on-board cameras during driving situation. Receives: Other: Driving situation and video feedback |
| Without video feedback | Other | Non-Activation of on-board cameras during driving situation. Receives: Other: Driving situation and usual recommendations (without video feedback) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of driving behavior.
This criterion will be measured using the difference between patient's and the professional's scores from the interview with the situation analyzes.
If the difference between the patient's score and that of the professionals is close to zero, it means that the patient correctly self-estimates their driving abilities. If the difference is positive, it means the patient overestimates their abilities. If the difference is negative, it means the patient underestimates their abilities.
The professionals score is the mean of the score of each professional (occupational therapist and driving instructor)
The patient fills out the questionnaire before and after the interview. The two professionals fill out the questionnaire once, before the interview. This score of driving behavior awareness after the interview will be compared to that before the interview, reflecting any potiential change in awareness following the interview.
Measured: Day 0
Secondary outcomes (13)
The concordance between the opinion of the two professionals (driving instructor and occupational therapist) and that of the patient about returning to driving, then compare this concordance between the two arms.
The score of question 4 of the "Q final-pro" questionnaire will be compared to question 7 of the "Q final-pa" questionnaire (with or without feedback depending on the arm). The differences between the two opinions (Patient Opinions-Professional Opinions) on all the evaluations will allow to establish a score "of concordance of the opinions of rework". A score equal to zero means that the opinions are the same between the patient and the professionals (best outcome), a positive or negative score means that the opinions are divergent. The closer the score is to zero, the better the result. The same process will be followed with the control group that did not receive video feedback in order to compare the concordance scores of the rework notices between the two arms.
Measured: Day 0
The concordance between the opinion of the driving teacher and the occupational therapist after the on-road test
Study of the concordance between the total score of the TRIP (Test Ride for Investigating Practical Fitness to Drive) grid (Qpost-cond-trip) of the driving teacher and that of the occupational therapist (score/100)
Calcul of a correlation coefficient : the higher the coefficient, the more consistent the assessments between the 2 professionals are (better outcome).
Measured: Day 0
The concordance between the opinion of the driving teacher and the occupational therapist for the interview grid
Study of the concordance between the total score of the interview grid (Qentr-pro) of the driving teacher and that of the occupational therapist (score/28).
Calcul of a correlation coefficient : the higher the coefficient, the more consistent the assessments between the 2 professionals are (better outcome).
Measured: Day 0
Compare the MOCA score between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
- [MOCA test /30 score] PFO compared to PUO (MOCA : Montreal Cognitive Assessment)
Measured: Day 0
Compare the score of Rey's Figure between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
- [Rey's Figure score /36, execution time (s)] PFO compared to PUO
Measured: Day 0
Compare the score of Bell Test between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
- [Bell Test score /35, execution time (s)] PFO compared to PUO
Measured: Day 0
Compare the attentional performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
TAP Scores PFO compared to PUO (TAP : Attention Assessment Tests)
Measured: Day 0
Compare the information processing speed between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
- Score combining the scores at the code and symbol tests /38 ] PFO compared to PUO (WAIS : Wechsler Adult Intelligence Scale)
Measured: Day 0
Compare the working memory performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
- [WAIS-IV digit memory score /19] PFO compared to PUO
Measured: Day 0
Links between cognitive performance and the awareness score of driving skills.
To study the links between cognitive performance and awareness, MOCA score will be correlated with awareness scores (Patient Score Difference - Professional Score obtained before the interview (Qentr-pro completed before the interview)).
Measured: Day 0
Links between awareness of cognitive impairment and awareness of driving skills.
To assess awareness of cognitive disorders, the difference in scores (Patient Score / Self-assessment - Professional Score / Hetero-assessment) of the BRIEF A will be calculated.
The Brief A test (Behavior Rating Inventory of Executive Function) aims to investigate the existence of a deficit of consciousness of cognitive disorders in patients. The patient's assessment score from the self-assessment questionnaire will be compared with that of professionals (hetero-assessment). The difference between the two scores (Patient Score / Self-assessment - Average Professional Score / Hetero-assessment) will determine whether the patient has a lack of awareness of his cognitive disorders. If the difference (Patient Score - Professional Score) is positive, the patient overestimates his disorders; if it is negative, the patient underestimates them; if it is zero it means that the patient is estimating them correctly.
Measured: Day 0
Become patients at 6 months
The behaviors and driving strategies of patients 6 months after their resumption of driving (Q follow-up) will be compared with those declared in the initial questionnaire on the answers to the following questions: "Since you have resumed driving, do you think that you have more difficulty driving than before? "," If so, in which situations do you think you have more difficulty "," Since your recovery, do you think you are avoiding more situations than before? "," If so, what are the situations you think you can avoid the most? "," Since your recovery, have you developed different driving strategies for driving? "," If so, what strategies have you put in place to drive safely "," Since your recovery, has the activity of driving scared you more than before? "," Do you think the activity of driving is more tiring than before? "
Measured: At 6 months
Acceptability of the video device by professionals and patients
The acceptability of the video device by professionals will be measured by the answers obtained to question 6 of the final questionnaire completed by professionals (Qfinal-pro) (e.g. questions: as a professional, having video feedback was easy to use during the interview, choice of items to tick). The closer the score is to 12, the higher the acceptability of the video device by professionals.
The acceptability of the video device by the patients will be measured thanks to the feelings that the patients will have expressed in question 2 of the final questionnaire (on interest, pleasure, stress, perceived usefulness, satisfaction and pleasure experienced by compared to the device).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start12 Oct 2021
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is part of a Research Involving the Human Person of the interventional with minimal risks and constraints type (RIPH2).This is a prospective, monocentric, comparative, randomized and controlled study.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Collaborators
- University Gustave Eiffel
- Responsible party
- Sponsor
- Investigators
- Pauline Coignard, Doctor, Principal investigator, CMRRF de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530134
- Sponsor's protocol ID
- 2020-A03377-32
- Acronym
- AUTOCAM-AVC
- Status last verified
- Jul 2024
- First submitted
- 20 Oct 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promote Awareness of the Driving Abilities of Post-stroke Patients: Interest of On-board Cameras and Self-assessment Questionnaires During a Driving Situation.
- ClinicalTrials.gov ID
- NCT06530134
- Acronym / sponsor ID
- AUTOCAM-AVC / 2020-A03377-32
- Conditions
- Cerebrovascular Accident
- Keywords
- post-stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Collaborators
- University Gustave Eiffel
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 31 Jul 2024 (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.
Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities.
This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams.
The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is part of a Research Involving the Human Person of the interventional with minimal risks and constraints type (RIPH2).This is a prospective, monocentric, comparative, randomized and controlled study.
| Arm | Type | Receives |
|---|---|---|
| With video feedback | Experimental | Other: Driving situation and video feedbackActivation of on-board cameras during driving situation. |
| Without video feedback | Other | Other: Driving situation and usual recommendations (without video feedback)Non-Activation of on-board cameras during driving situation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stroke (ischemic and / or hemorrhagic) between 1 month and 6 months
- Holder of a driving license for more than 3 years
- No resumption of driving
- MoCA score ≥ 10
- Affiliation to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (8 listed)
- Aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision <6/10, visual field <120 ° in binocular, <50 ° to the right and to the left beyond the central point, <30 ° vertically.
- History of neurological disease responsible for cognitive impairment
- Need for vehicle modifications except automatic gearbox
- Subject being in a period of exclusion from another protocol
- Insufficient command of the French language
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 |
|---|---|---|
| Driving situation and video feedbackAt the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation using video feedback. | Other | With video feedback |
| Driving situation and usual recommendations (without video feedback)At the end of the driving situation, 35 patients will be asked to express themselves and analyze 4 driving situations resulting from the course of the driving situation without video feedback, according to the usual recommendations. Comparison of responses to all questionnaires and interview grids sent before and after driving, to patients and professionals will determine whether video feedback promotes awareness of the difficulties of driving post-stroke patients. | Other | Without video feedback |
Primary outcome
Awareness of driving behavior.
Time frame: Day 0
This criterion will be measured using the difference between patient's and the professional's scores from the interview with the situation analyzes. If the difference between the patient's score and that of the professionals is close to zero, it means that the patient correctly self-estimates their driving abilities. If the difference is positive, it means the patient overestimates their abilities. If the difference is negative, it means the patient underestimates their abilities. The professionals score is the mean of the score of each professional (occupational therapist and driving instructor) The patient fills out the questionnaire before and after the interview. The two professionals fill out the questionnaire once, before the interview. This score of driving behavior awareness after the interview will be compared to that before the interview, reflecting any potiential change in awareness following the interview.
13 secondary outcomes
The concordance between the opinion of the two professionals (driving instructor and occupational therapist) and that of the patient about returning to driving, then compare this concordance between the two arms.
Time frame: Day 0
The concordance between the opinion of the driving teacher and the occupational therapist after the on-road test
Time frame: Day 0
The concordance between the opinion of the driving teacher and the occupational therapist for the interview grid
Time frame: Day 0
Compare the MOCA score between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Compare the score of Rey's Figure between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Compare the score of Bell Test between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Compare the attentional performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Compare the information processing speed between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Compare the working memory performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)
Time frame: Day 0
Links between cognitive performance and the awareness score of driving skills.
Time frame: Day 0
Links between awareness of cognitive impairment and awareness of driving skills.
Time frame: Day 0
Become patients at 6 months
Time frame: At 6 months
Acceptability of the video device by professionals and patients
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Pauline Coignard, Doctor principal investigator
CMRRF de Kerpape
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving situation and video feedback and Driving situation and usual recommendations (without video feedback) in people with Cerebrovascular Accident, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline Coignard, Doctor (0297826179 ext. +33, pauline.coignard@vyv3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of driving behavior. (time frame: Day 0). 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 31 Jul 2024.