Cognitive Evaluation for Driving After a Stroke.

NCT05659667 | Completed

• 1 other identifier: 1607-N-21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Drive

Keywords

fitness to drive; assessment; occupational therapy; cognition

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Baseline

Secondary Outcomes (16)

• Mini-Mental State Examination

  Baseline

• Visual Object and Space Perception Battery (VOSP)

  Baseline

• The Useful Field of View Test (UFOV)

  Baseline

• Trail Making Test

  Baseline

• Continuous Performance Test (CPT)

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Universidad de Granada: collaborator

Study Sites (1)

María Rodríguez Bailón

Málaga, 29016, Spain

Location

Related Publications (5)

• 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.

  PMID: 32421733 BACKGROUND

• 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.

  PMID: 27474026 BACKGROUND

• 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.

  PMID: 31088186 BACKGROUND

• 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.

  PMID: 29488407 BACKGROUND

• 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.

  PMID: 28524365 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Candida Castro-Ramirez

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

ES (1)