StrokeDrive-StrokeNCT05659667
Cognitive Evaluation for Driving After a Stroke.
An observational study of Stroke and Drive, run by University of Malaga at 1 site in Spain.
Trial summary
Driving is a common activity which is crucial for most adults. It allows a mobility that contributes to the physic and economic independence. Stroke is an accute process and relatively common in developed countries, and it consists in the abrupt interruption of blood supply anywhere in the brain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 1 Dec 2023
- Phase
- Observational
- 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 70 years
- All sexes
- Adult, Older adult
Study population: * Case group: 50 adults (between 18 and 70 years old) in chronic phase of stroke (> 6 months from stroke), in possession of driving license and having to have driven in the three months before stroke. * Control group: 50 healthy adults with the same age as case group, match up in driving experience, age, sex and educational level with the group of people with stroke and driver´s license in validity.
Who may be able to join
- Participants must have the driver´s license.
- Age:18-70 years
- For patients:
- They must have the medical authorization for participating in the study (indicating that they are medically stable to participate in the study, regardless of whether they can drive or not).
- Chronic phase of stroke (> 6 months from stroke)
- They have driven in the three months before stroke.
Who cannot join
- Patients will be excluded if they have a stroke score below 24 on the Mini Mental State Examination, epileptic seizures, visual impairments (uncorrected visual acuity with glasses, diplopia, severe campimetric or visual field deficits, etc.), attentional hemineglect syndrome, severe balance disturbances and people who don't know/can read.
- They will be required to be able to move independently in a standing position, even if they need the help of assistive devices to do so.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elaboration of a Sensitive Evaluation Protocol to the Necessary Cognitive Processes for Driving After Stroke
Driving is a common activity which is crucial for most adults. It allows a mobility that contributes to the physic and economic independence. Stroke is an accute process and relatively common in developed countries, and it consists in the abrupt interruption of blood supply anywhere in the brain. Suffering a stroke is a road risk factor, because leaves sequelae in the driver that may interfere with the necessary capacities (including cognitive abilities) for a security driving. For stroke survivors (as young as adults), the fact of stop driving interferes with the activities that provides independence in their lives, so the posibility of driving again woul mean a big step in their recovery.
Driving is a complex activity that requires the proper functioning of cognitive and physical processes and functions, as well as appropriate behaviour to make good and quick decisions in different traffic situations. Within these cognitive and behavioural functions, we can talk about executive functions such as planning, cognitive flexibility or decision making; processing speed, praxis, perception, attention, memory, language comprehension and writing, and awareness of one's own abilities and deficits. Because of the complexity, relevance and number of cognitive processes required for safe driving, it is important to know and be able to measure the cognitive processes involved in the activity of driving. The main general objective of this project is to improve comprehension of cognitive elements that predict safe driving in patients who have suffered a stroke. This would allow the creation of a sensitive cognitive assessment protocol to determine the ability of people with stroke to drive again.
Read the detailed description
The aim of creating this protocol is to determine the tests that best predict safe driving after stroke. This protocol will be composed by different cognitive tools, classified in two categories: Off-Road tests and On-Road tests.
- In the Off-Road category there are two different parts:
1.a) One of these is "non-driving tests", in which we use cognitive tools that the scientific literature has shown to be predictive of safe driving, but which are not contextualised within the activity of driving. Perception is important for calculating distances as well as to distinguish between figure and background. "Visual Object and Space Perception Battery" (VOSP) will be administered to measure perception. It requires a good attentional orientation that encompasses the entire attentional field equally, in addition to sustained, selective and divided attention. So, for measure attention, we will use "The Used Field of View Test" (UFOV), "Trail Making Test" (Part A and B) and "Continuous Performance Test" (CPT). Mnesic abilities are essentials to record and maintain the memory while driving as well as the coding processes that allow the retention of visual information, or the working and prospective memory to remember the itinerary and the destination. For this purpose the "Paced Auditory Serial Addition Test" (PASAT) will be used. Executive functions are used to identify and solve new problems or situations quickly and effectively enough. To measure this, "Iowa Gambling Test", the "Five - Digit Test", and the "Spanish Weekly Planning Calendar Activity - 10" (Spanish WCPA-10) will be administered. In the reviewed literature on neuropsychological tests for predicting driving performance, there is a notable absence of references to motor and cognitive aspects related to practical driving. A test was proposed by experts during protocol development, combining subtests from "INECO Frontal Screening" and Luria's "Premotor Series" to address this gap. To assess personality-related aspects such as risk-taking, sensitivity to punishment and reward, the "Sensitivity to Punishment and Sensitivity to Reward Questionnaire" (SPSRQ-20) and "Domain-Specific Risk-Taking" (DOSPERT) will be employed. Lastly, the "Psycho-technical driving test" will be used for a general cognitive screening.
1.b) In the other part of Off-Road category, "driving tests" (contextualised within the activity of driving) will be included. One of them is new creation scale called COMAP, a test of planning, within the strategic level. Another test is the global cognitive evaluation for driving ability called "Stroke Drivers´ Screening Assessment" (SDSA), which includes sub-tests of attention, semantic memory and spatial relations. The SDSA has been created and validated in the English context, so the proposal is to validate it in the Spanish population with brain damage.To evaluate the personality and risk estimation, we use "Multi-driving Styles Inventory" (MDSI), "Hazard Perception Test", "Risk Estimation Test".
- The On-Road category is composed of a newly created test called "EDEC" (Performance Assessment Driving), which will be validated both for simulator driving and for the driving test with a real car on an open circuit.
- Keywords
- fitness to drive, assessment, occupational therapy, cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Case group: 50 adults (between 18 and 70 years old) in chronic phase of stroke (> 6 months from stroke), in possession of driving license and having to have driven in the three months before stroke. | |
| Healthy adults | 50 healthy adults with the same age as case group, match up in driving experience, age, sex and educational level with the group of people with stroke, and driver´s license in validity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation of Driving (EDEC)
The On-Road category is composed of a newly created test called "EDEC" (Performance Assessment Driving), which will be validated both for simulator driving and for the driving test with a real car on an open circuit.
The EDEC assesses driving performance in people who have suffered a stroke.The evaluation is structured in 3 moments: before, during and after driving, in a simulator driving and in a circuit open to traffic. During these moments, specific actions related to driving are assessed, related to Michon's three levels (1971, 1978, 1985).
The researcher will observe the performance of the items on several occasions, assigning the corresponding score to each item.
An inter-observer reliability study will be carried out, so that two researchers will evaluate with this test. The assessment is carried out in a manual or automatic dual-control vehicle (passenger car).
Measured: Baseline
Evaluation of driving planning on Map (COMAP)
This new creation test is based on other planification test, such as Weekly Calendar Planning Activity (WCPA), and it intends to measure the cognitive aspects involved in the general planning phase prior to driving. The person will have to organize and design (in the map) the route that will follow, to complete 5 necessary tasks for passing the weekend in a village house. The evaluator must rate the performance of the person in the COMAP. We will collect the following variables: time required, the strategies and test performance.
Measured: Baseline
STROKE DRIVERS´ SCREENING ASSESSMENT (SDSA)
It is a cognitive test developed in United Kingdom, that evaluates fitness to drive in people with stroke. The SDSA was designed and validated for stoke patients. It provides clinically useful information about cognitive functions that are relevant to driving (concentration and sustained attention, mental speed, memory, reasoning and the ability to attend to two different visual dimensions at the same time). It is made up of 4 tasks: Dot Cancellation Test, Direction Test, Compass Test and Road Sign Recognition Test. Since it is a test that has demonstrated predictive validity in driving and since it is the only test found that includes semantic memory of traffic signs, we decided to include it. To do so, we need to validate it in the Spanish context with the clinical population that we already included in this project.
Measured: Baseline
OBSERVATIONAL EVALUATION OF REAL DRIVING (ON-ROAD TEST)
This assessment shall consist of observing the participant's driving performance in a real car test.This evaluation will be carried out by qualified staff in driving school's cars with all security measures and necessary controls. The driving instructor's assessment may have options: favourable, doubtful and unfavorable. The evaluation of this test will be done in conjunction with the EDEC.
Measured: Baseline
Secondary outcomes (16)
Mini-Mental State Examination
It is used to obtain a measure of the general cognitive status. MMSE is a 30-point questionnaire that is extensively used in clinical and research settings to measure cognitive impairment (it is commonly used in medicine and allied health to screen for dementia). It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment.
Measured: Baseline
Visual Object and Space Perception Battery (VOSP)
VOSP is a battery for the evaluation of the visual recognition and visoperceptive abilities. This test only need a verbal answer from the patient, after a visual exposition of a stimulus. For this Project, we will only administrate the subtests which are validated in spanish population:
- Shape detection.
- Test 3: Object decisión.
- Test 4: progressive outline.
- Test 5: position discrimination
- Number localization.
Measured: Baseline
The Useful Field of View Test (UFOV)
It is a visual processing and visual attention test that is administered by computer and has got three subtests: processing speed, divided attention, and selective attention. The divided and selective attention subtest have been asociated significatly with the patient's classification with stroke to pass or fail in driving test.
Measured: Baseline
Trail Making Test
It evaluates divided attention and attentional executive control. It has two parts: A) It consists of joining consecutive numbers scattered on a sheet. B) Not only there are numbers, but also letters. It consists of joining numbers and letters in order, alternating numbers and letters (1-A, 2-B,). Execution time and errors are evaluated.
Measured: Baseline
Continuous Performance Test (CPT)
Computerized test to measure sustained attention and attentional vigilance. We give to the person an instruction to detect a specific letter that appear in the computer screen, in a letter group showed in a short period of time and separated also for very brief spaces of time. Letter detection ability and reaction time are evaluated.
Measured: Baseline
Paced Auditory Serial Addition Test (PASAT)
It measures work memory, calculation, and information processing speed. The evaluator says numbers aloud, and the participant must add the number that the evaluator has just said to him with the previous number that he has said.
Measured: Baseline
INECO Frontal Screening
This screening test was designed to provide health professionals with a sensitive and specific executive screening test to determine frontal dysfunction in patients with dementia.
Measured: Baseline
Five Digit Test
This test evaluates executive attention, measuring the person's ability to manage the interference. Consists of 4 parts: 1) The person must say the value of a number that appear in a square. 2) The person must say the amount of stars that appear in a square. 3) The person must say the amount of number that appear in a square. 4) The person must say the number or the amount of numbers that appear, depending on the thickness of the square.
Measured: Baseline
Iowa Gambling Test
It is a test to evaluate decisions making, which requires cognitive and emotional abilities. Four cards shuffle are introduced to the dubject (A,B,C and D) and it is indicated that if he lift card, he will gain or loss money. The person starts with a determinate amount of cards that the bank lends him, and it is indicated that he must gain money and loss the less money possible. All cards presentated give money and lost money, but in cards A and B the amount of money that you loss could be higher than in cards C and D. The person must discover what cards are more rentable with the goal to gain money and not lose a lot of money.
Measured: Baseline
Weekly Calendar Planning Activity (WCPA)
This is a performance based test that measures different executive functions, among which are: planning, problem solving, inhibition of non-relevant information and maintenance and monitoring of rules. In its short version, it is based on asking the patient to schedule 10 appointments (that appear in random order) during a 1 week span. Some appointments are incompatible with others, so the patient has to take them into account to plan correctly. In addition, the patient is asked to comply with 5 rules which are informed at the beginning of the test and are kept in view throughout the task. The test provides different variables for its analysis, as well as the successes when planning, such as the types of mistakes made, the ability to detect them, the time, the rules followed or the strategies used.
Measured: Baseline
Domain-Specific Risk-Taking (DOSPERT)
It was designed to evaluate as risk estimation attitudes as function of perceived risk in different aspects of the life. In this studio we will use the risk perception subtest of the translated version by Rubio and Narváez. It has got 30 ítems in likert-type format with seven different answers, where 1 is "nothing risked" and 7 is "extremely risked". The Subjective Estimation of Risk (EsdR) depends on the own self-evaluation of driving ability and risk calibration in the driving moment, in function of the estimation of the benefits and costs of such risk. The highest risk estimation in reoffending drivers could relate with one more global factor that also implies the estimate of his risk in other facets of life that lead to drug use or other additions. A low ESdR in a situation could be a feature, a greater propensy to show some drivers like a personality characteristic.
Measured: Baseline
Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ-20)
It is a self-reported likert-type scale whose objective is to measure sensitivity to punishment and reward. Sensitivity to Punishment (SP) is related to the inhibition of the behaviour and signals of punishment, while Sensitivity to Reward (SR) is related to the abscense inhibition of behaviour and with the awareness of reinforcement signals. The items of this questionnaire are in likert-type format with four altenative for answer where 1 is "strongly disagree" and 4 is "strongly agree".
Measured: Baseline
Multi-driving Styles Inventory (MDSI)
It is a self-reported likert-type scale asking about the person's perceived driving styles: reckless, aggressive, anxious, distracted, cautious and stress reduction.
Measured: Baseline
Hazard Perception Test
This is a computer-based test contextualised in the driving context. The person is shown 39 videos of a real traffic situation and must identify exactly what the risk of the situation is.
Measured: Baseline
Risk Estimation Test
This test is formed by 40 videos in which the person must estimate the risk posed by a traffic situation in a scale from 1 to 6.
Measured: Baseline
Psycho-technical driving test
Driving aptitude test, based on these dimensions: Concentrated attention, Multiple reactions, Anticipatory speed, Bimanual coordination, Decision making and Personality
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 May 2022
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Principal investigator, María Rodríguez Bailón, University of Malaga
- Investigators
- Candida Castro-Ramirez, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659667
- Sponsor's protocol ID
- 1607-N-21
- Acronym
- Drive-Stroke
- Status last verified
- Mar 2024
- First submitted
- 2 Dec 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellagamba D, Vionnet L, Margot-Cattin I, Vaucher P. Standardized on-road tests assessing fitness-to-drive in people with cognitive impairments: A systematic review. PLoS One. 2020 May 18;15(5):e0233125. doi: 10.1371/journal.pone.0233125. eCollection 2020.
PubMed 32421733Wolfe PL, Lehockey KA. Neuropsychological Assessment of Driving Capacity. Arch Clin Neuropsychol. 2016 Sep;31(6):517-29. doi: 10.1093/arclin/acw050. Epub 2016 Jul 29.
PubMed 27474026Selander H, Wressle E, Samuelsson K. Cognitive prerequisites for fitness to drive: Norm values for the TMT, UFOV and NorSDSA tests. Scand J Occup Ther. 2020 Apr;27(3):231-239. doi: 10.1080/11038128.2019.1614214. Epub 2019 May 15.
PubMed 31088186Unsworth CA, Baker A, Lannin N, Harries P, Strahan J, Browne M. Predicting fitness-to-drive following stroke using the Occupational Therapy - Driver Off Road Assessment Battery. Disabil Rehabil. 2019 Jul;41(15):1797-1802. doi: 10.1080/09638288.2018.1445784. Epub 2018 Feb 28.
PubMed 29488407Fields SM, Unsworth CA. Revision of the Competency Standards for Occupational Therapy Driver Assessors: An overview of the evidence for the inclusion of cognitive and perceptual assessments within fitness-to-drive evaluations. Aust Occup Ther J. 2017 Aug;64(4):328-339. doi: 10.1111/1440-1630.12379. Epub 2017 May 19.
PubMed 28524365
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of a Sensitive Evaluation Protocol to the Necessary Cognitive Processes for Driving After Stroke
- ClinicalTrials.gov ID
- NCT05659667
- Acronym / sponsor ID
- Drive-Stroke / 1607-N-21
- Keywords
- fitness to drive, assessment, occupational therapy, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Dec 2022 (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.
Driving is a common activity which is crucial for most adults. It allows a mobility that contributes to the physic and economic independence. Stroke is an accute process and relatively common in developed countries, and it consists in the abrupt interruption of blood supply anywhere in the brain. Suffering a stroke is a road risk factor, because leaves sequelae in the driver that may interfere with the necessary capacities (including cognitive abilities) for a security driving. For stroke survivors (as young as adults), the fact of stop driving interferes with the activities that provides independence in their lives, so the posibility of driving again woul mean a big step in their recovery.
Driving is a complex activity that requires the proper functioning of cognitive and physical processes and functions, as well as appropriate behaviour to make good and quick decisions in different traffic situations. Within these cognitive and behavioural functions, we can talk about executive functions such as planning, cognitive flexibility or decision making; processing speed, praxis, perception, attention, memory, language comprehension and writing, and awareness of one's own abilities and deficits. Because of the complexity, relevance and number of cognitive processes required for safe driving, it is important to know and be able to measure the cognitive processes involved in the activity of driving. The main general objective of this project is to improve comprehension of cognitive elements that predict safe driving in patients who have suffered a stroke. This would allow the creation of a sensitive cognitive assessment protocol to determine the ability of people with stroke to drive again.
Detailed description
The aim of creating this protocol is to determine the tests that best predict safe driving after stroke. This protocol will be composed by different cognitive tools, classified in two categories: Off-Road tests and On-Road tests.
- In the Off-Road category there are two different parts:
1.a) One of these is "non-driving tests", in which we use cognitive tools that the scientific literature has shown to be predictive of safe driving, but which are not contextualised within the activity of driving. Perception is important for calculating distances as well as to distinguish between figure and background. "Visual Object and Space Perception Battery" (VOSP) will be administered to measure perception. It requires a good attentional orientation that encompasses the entire attentional field equally, in addition to sustained, selective and divided attention. So, for measure attention, we will use "The Used Field of View Test" (UFOV), "Trail Making Test" (Part A and B) and "Continuous Performance Test" (CPT). Mnesic abilities are essentials to record and maintain the memory while driving as well as the coding processes that allow the retention of visual information, or the working and prospective memory to remember the itinerary and the destination. For this purpose the "Paced Auditory Serial Addition Test" (PASAT) will be used. Executive functions are used to identify and solve new problems or situations quickly and effectively enough. To measure this, "Iowa Gambling Test", the "Five - Digit Test", and the "Spanish Weekly Planning Calendar Activity - 10" (Spanish WCPA-10) will be administered. In the reviewed literature on neuropsychological tests for predicting driving performance, there is a notable absence of references to motor and cognitive aspects related to practical driving. A test was proposed by experts during protocol development, combining subtests from "INECO Frontal Screening" and Luria's "Premotor Series" to address this gap. To assess personality-related aspects such as risk-taking, sensitivity to punishment and reward, the "Sensitivity to Punishment and Sensitivity to Reward Questionnaire" (SPSRQ-20) and "Domain-Specific Risk-Taking" (DOSPERT) will be employed. Lastly, the "Psycho-technical driving test" will be used for a general cognitive screening.
1.b) In the other part of Off-Road category, "driving tests" (contextualised within the activity of driving) will be included. One of them is new creation scale called COMAP, a test of planning, within the strategic level. Another test is the global cognitive evaluation for driving ability called "Stroke Drivers´ Screening Assessment" (SDSA), which includes sub-tests of attention, semantic memory and spatial relations. The SDSA has been created and validated in the English context, so the proposal is to validate it in the Spanish population with brain damage.To evaluate the personality and risk estimation, we use "Multi-driving Styles Inventory" (MDSI), "Hazard Perception Test", "Risk Estimation Test".
- The On-Road category is composed of a newly created test called "EDEC" (Performance Assessment Driving), which will be validated both for simulator driving and for the driving test with a real car on an open circuit.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Case group: 50 adults (between 18 and 70 years old) in chronic phase of stroke (> 6 months from stroke), in possession of driving license and having to have driven in the three months before stroke. |
| Healthy adults | – | –50 healthy adults with the same age as case group, match up in driving experience, age, sex and educational level with the group of people with stroke, and driver´s license in validity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Case group: 50 adults (between 18 and 70 years old) in chronic phase of stroke (> 6 months from stroke), in possession of driving license and having to have driven in the three months before stroke. * Control group: 50 healthy adults with the same age as case group, match up in driving experience, age, sex and educational level with the group of people with stroke and driver´s license in validity.
Key inclusion criteria (6 listed)
- Participants must have the driver´s license.
- Age:18-70 years
- They must have the medical authorization for participating in the study (indicating that they are medically stable to participate in the study, regardless of whether they can drive or not).
- Chronic phase of stroke (> 6 months from stroke)
- They have driven in the three months before stroke.
Key exclusion criteria (2 listed)
- Patients will be excluded if they have a stroke score below 24 on the Mini Mental State Examination, epileptic seizures, visual impairments (uncorrected visual acuity with glasses, diplopia, severe campimetric or visual field deficits, etc.), attentional hemineglect syndrome, severe balance disturbances and people who don't know/can read.
- They will be required to be able to move independently in a standing position, even if they need the help of assistive devices to do so.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance Evaluation of Driving (EDEC)
Time frame: Baseline
The On-Road category is composed of a newly created test called "EDEC" (Performance Assessment Driving), which will be validated both for simulator driving and for the driving test with a real car on an open circuit. The EDEC assesses driving performance in people who have suffered a stroke.The evaluation is structured in 3 moments: before, during and after driving, in a simulator driving and in a circuit open to traffic. During these moments, specific actions related to driving are assessed, related to Michon's three levels (1971, 1978, 1985). The researcher will observe the performance of the items on several occasions, assigning the corresponding score to each item. An inter-observer reliability study will be carried out, so that two researchers will evaluate with this test. The assessment is carried out in a manual or automatic dual-control vehicle (passenger car).
Evaluation of driving planning on Map (COMAP)
Time frame: Baseline
This new creation test is based on other planification test, such as Weekly Calendar Planning Activity (WCPA), and it intends to measure the cognitive aspects involved in the general planning phase prior to driving. The person will have to organize and design (in the map) the route that will follow, to complete 5 necessary tasks for passing the weekend in a village house. The evaluator must rate the performance of the person in the COMAP. We will collect the following variables: time required, the strategies and test performance.
STROKE DRIVERS´ SCREENING ASSESSMENT (SDSA)
Time frame: Baseline
It is a cognitive test developed in United Kingdom, that evaluates fitness to drive in people with stroke. The SDSA was designed and validated for stoke patients. It provides clinically useful information about cognitive functions that are relevant to driving (concentration and sustained attention, mental speed, memory, reasoning and the ability to attend to two different visual dimensions at the same time). It is made up of 4 tasks: Dot Cancellation Test, Direction Test, Compass Test and Road Sign Recognition Test. Since it is a test that has demonstrated predictive validity in driving and since it is the only test found that includes semantic memory of traffic signs, we decided to include it. To do so, we need to validate it in the Spanish context with the clinical population that we already included in this project.
OBSERVATIONAL EVALUATION OF REAL DRIVING (ON-ROAD TEST)
Time frame: Baseline
This assessment shall consist of observing the participant's driving performance in a real car test.This evaluation will be carried out by qualified staff in driving school's cars with all security measures and necessary controls. The driving instructor's assessment may have options: favourable, doubtful and unfavorable. The evaluation of this test will be done in conjunction with the EDEC.
16 secondary outcomes
Mini-Mental State Examination
Time frame: Baseline
Visual Object and Space Perception Battery (VOSP)
Time frame: Baseline
The Useful Field of View Test (UFOV)
Time frame: Baseline
Trail Making Test
Time frame: Baseline
Continuous Performance Test (CPT)
Time frame: Baseline
Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline
INECO Frontal Screening
Time frame: Baseline
Five Digit Test
Time frame: Baseline
Iowa Gambling Test
Time frame: Baseline
Weekly Calendar Planning Activity (WCPA)
Time frame: Baseline
Domain-Specific Risk-Taking (DOSPERT)
Time frame: Baseline
Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ-20)
Time frame: Baseline
Multi-driving Styles Inventory (MDSI)
Time frame: Baseline
Hazard Perception Test
Time frame: Baseline
Risk Estimation Test
Time frame: Baseline
Psycho-technical driving test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 32421733Bellagamba D, Vionnet L, Margot-Cattin I, Vaucher P. Standardized on-road tests assessing fitness-to-drive in people with cognitive impairments: A systematic review. PLoS One. 2020 May 18;15(5):e0233125. doi: 10.1371/journal.pone.0233125. eCollection 2020.
- Background: PubMed 27474026Wolfe PL, Lehockey KA. Neuropsychological Assessment of Driving Capacity. Arch Clin Neuropsychol. 2016 Sep;31(6):517-29. doi: 10.1093/arclin/acw050. Epub 2016 Jul 29.
- Background: PubMed 31088186Selander H, Wressle E, Samuelsson K. Cognitive prerequisites for fitness to drive: Norm values for the TMT, UFOV and NorSDSA tests. Scand J Occup Ther. 2020 Apr;27(3):231-239. doi: 10.1080/11038128.2019.1614214. Epub 2019 May 15.
- Background: PubMed 29488407Unsworth CA, Baker A, Lannin N, Harries P, Strahan J, Browne M. Predicting fitness-to-drive following stroke using the Occupational Therapy - Driver Off Road Assessment Battery. Disabil Rehabil. 2019 Jul;41(15):1797-1802. doi: 10.1080/09638288.2018.1445784. Epub 2018 Feb 28.
- Background: PubMed 28524365Fields SM, Unsworth CA. Revision of the Competency Standards for Occupational Therapy Driver Assessors: An overview of the evidence for the inclusion of cognitive and perceptual assessments within fitness-to-drive evaluations. Aust Occup Ther J. 2017 Aug;64(4):328-339. doi: 10.1111/1440-1630.12379. Epub 2017 May 19.
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
Candida Castro-Ramirez principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Drive, run by University of Malaga at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 21 Mar 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance Evaluation of Driving (EDEC) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659667, which also lists 5 linked publications.
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 21 Mar 2024.