Elaboration of a Sensitive Evaluation Protocol to the Necessary Cognitive Processes for Driving After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Performance Evaluation of Driving (EDEC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Performance Evaluation of Driving (EDEC)
时间窗: 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).
STROKE DRIVERS´ SCREENING ASSESSMENT (SDSA)
时间窗: 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.
Evaluation of driving planning on Map (COMAP)
时间窗: 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.
OBSERVATIONAL EVALUATION OF REAL DRIVING (ON-ROAD TEST)
时间窗: 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.
次要结局
- Visual Object and Space Perception Battery (VOSP)(Baseline)
- Psycho-technical driving test(Baseline)
- Mini-Mental State Examination(Baseline)
- Weekly Calendar Planning Activity (WCPA)(Baseline)
- The Useful Field of View Test (UFOV)(Baseline)
- Trail Making Test(Baseline)
- INECO Frontal Screening(Baseline)
- Domain-Specific Risk-Taking (DOSPERT)(Baseline)
- Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ-20)(Baseline)
- Risk Estimation Test(Baseline)
- Paced Auditory Serial Addition Test (PASAT)(Baseline)
- Five Digit Test(Baseline)
- Multi-driving Styles Inventory (MDSI)(Baseline)
- Hazard Perception Test(Baseline)
- Continuous Performance Test (CPT)(Baseline)
- Iowa Gambling Test(Baseline)
研究者
María Rodríguez Bailón
Principal Investigator
University of Malaga