Clinical trial NCT05659667: Cognitive Evaluation for Driving After a Stroke.
Official title: Elaboration of a Sensitive Evaluation Protocol to the Necessary Cognitive Processes for Driving After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Drive
Keywords: fitness to drive
assessment
occupational therapy
cognition
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2022-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

1) 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".

2) 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Performance Evaluation of Driving (EDEC)
timeFrame: Baseline
measure: Evaluation of driving planning on Map (COMAP)
timeFrame: Baseline
measure: STROKE DRIVERS´ SCREENING ASSESSMENT (SDSA)
timeFrame: Baseline
measure: OBSERVATIONAL EVALUATION OF REAL DRIVING (ON-ROAD TEST)
timeFrame: Baseline
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: Baseline
measure: Visual Object and Space Perception Battery (VOSP)
timeFrame: Baseline
measure: The Useful Field of View Test (UFOV)
timeFrame: Baseline
measure: Trail Making Test
timeFrame: Baseline
measure: Continuous Performance Test (CPT)
timeFrame: Baseline
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline
measure: INECO Frontal Screening
timeFrame: Baseline
measure: Five Digit Test
timeFrame: Baseline
measure: Iowa Gambling Test
timeFrame: Baseline
measure: Weekly Calendar Planning Activity (WCPA)
timeFrame: Baseline
measure: Domain-Specific Risk-Taking (DOSPERT)
timeFrame: Baseline
measure: Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ-20)
timeFrame: Baseline
measure: Multi-driving Styles Inventory (MDSI)
timeFrame: Baseline
measure: Hazard Perception Test
timeFrame: Baseline
measure: Risk Estimation Test
timeFrame: Baseline
measure: Psycho-technical driving test
timeFrame: Baseline
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: María Rodríguez Bailón
Study officials:
affiliation: Universidad de Granada
name: Candida Castro-Ramirez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wolfe 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.
citation: Selander 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.
citation: Unsworth 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.
citation: Fields 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.