Promote Awareness of the Driving Abilities of Post-stroke Patients: Interest of On-board Cameras and Self-assessment Questionnaires During a Driving Situation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Awareness of driving behavior.
研究概览
简要总结
Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities.
This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams.
The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke (ischemic and / or hemorrhagic) between 1 month and 6 months
- •Holder of a driving license for more than 3 years
- •No resumption of driving
- •MoCA score ≥ 10
- •Affiliation to a social security scheme or beneficiary of such a scheme
- •Having signed a free, informed and written consent
- •Medically stable
排除标准
- •Aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision <6/10, visual field <120 ° in binocular, <50 ° to the right and to the left beyond the central point, <30 ° vertically.
- •History of neurological disease responsible for cognitive impairment
- •Need for vehicle modifications except automatic gearbox
- •Subject being in a period of exclusion from another protocol
- •Insufficient command of the French language
- •Protected adults (curators)
- •Pregnancy declared
- •Being unable to issue their consent
研究组 & 干预措施
With video feedback
Activation of on-board cameras during driving situation.
干预措施: Driving situation and video feedback (Other)
Without video feedback
Non-Activation of on-board cameras during driving situation.
干预措施: Driving situation and usual recommendations (without video feedback) (Other)
结局指标
主要结局
Awareness of driving behavior.
时间窗: Day 0
This criterion will be measured using the difference between patient's and the professional's scores from the interview with the situation analyzes. If the difference between the patient's score and that of the professionals is close to zero, it means that the patient correctly self-estimates their driving abilities. If the difference is positive, it means the patient overestimates their abilities. If the difference is negative, it means the patient underestimates their abilities. The professionals score is the mean of the score of each professional (occupational therapist and driving instructor) The patient fills out the questionnaire before and after the interview. The two professionals fill out the questionnaire once, before the interview. This score of driving behavior awareness after the interview will be compared to that before the interview, reflecting any potiential change in awareness following the interview.
次要结局
- Compare the MOCA score between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- Compare the score of Bell Test between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- The concordance between the opinion of the two professionals (driving instructor and occupational therapist) and that of the patient about returning to driving, then compare this concordance between the two arms.(Day 0)
- The concordance between the opinion of the driving teacher and the occupational therapist after the on-road test(Day 0)
- Compare the information processing speed between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- Compare the working memory performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- Links between awareness of cognitive impairment and awareness of driving skills.(Day 0)
- Compare the attentional performance between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- The concordance between the opinion of the driving teacher and the occupational therapist for the interview grid(Day 0)
- Compare the score of Rey's Figure between patients who had a favorable opinion (PFO) and patients who had an unfavorable opinion (PUO)(Day 0)
- Become patients at 6 months(At 6 months)
- Links between cognitive performance and the awareness score of driving skills.(Day 0)
- Acceptability of the video device by professionals and patients(Day 0)