跳至主要内容
临床试验/NCT06111989
NCT06111989招募中不适用

To Drive or Not to Drive? A Machine Learning Data Analysis Approach Among Stroke Patients

National Institute for Medical Rehabilitation, Hungary1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Driving test result

研究概览

简要总结

The goal of this observational study is to learn more about who can continue driving a car after a stroke. The focus of this study is on the relationship between cognitive abilities and fitness-to-drive.

Participants will be asked to perform an extended neuropsychological testing and a real life on-road test, conducted by a professional driving instructor. Feedback will be given to the participants on request.

详细描述

The relationship between cognitive abilities and driving skills is really complex. This study aims to introduce novel data analysing methods that can be used by medical professionals to decide whether the stroke patient is able to operate a vehicle safely or not.

The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator. This part will be approximately 2 hours. Since the first part is really tiresome, the test driving will be on an other day. The driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety.

Who can participate in the study:

  • Aged 65 or younger
  • Holds a driving licence
  • Had an ischemic or hemorrhagic stroke
  • Has sufficient physical abilities to operate a car
  • Does not have certain medical conditions such epilepsy

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 or younger
  • ischemic or hemorrhagic stroke
  • at least 6 months has passed after the stroke
  • holds a valid driver's licence

排除标准

  • visual impairments (eg. visual field loss, nystagmus or diplopia)
  • serious movement disorders (eg. hemiplegia) that hider operating a car
  • limb ataxia
  • aphasia types that affect comprehension
  • serious psychiatrical disorders

结局指标

主要结局

Driving test result

时间窗: through study completion, an average of 2 years

The driving instructor's classification (pass/fail)

次要结局

未报告次要终点

研究者

发起方
National Institute for Medical Rehabilitation, Hungary
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验