Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Type and number of driving errors
研究概览
简要总结
For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help mitigate functional deficits, improve driving performance, decrease driving errors and enhance their ability to stay on the road. Using a pretest/posttest design the investigators will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide recommendations to drivers with PD, the clinical community and industry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25
- •Has mild or moderate disease severity, based on the MDS-Unified Parkinson's Disease Rating Scale for motor symptoms (hereafter referred to as the UPDRS section 3) in the on state of medications (i.e., one hour of taking PD medications) and the Modified Hoehn and Yahr disease severity scale
- •Is representative of one of two PD groups based on age, i.e., participants with symptom onset between 35-64 years of age (younger onset), or participants with symptom onset between ages 65- 85 years (older onset)
- •Currently driving with a valid license
- •Meets the Florida state requirement for visual acuity of at least 20/50 in one eye, if one eye is blind or 20/200 or worse the other eye must be 20/40 or better (20/40 in at least one eye) and field of vision (130 degrees or more)
- •Lives independently in the community
- •Proficient in reading/speaking English
- •A Montreal Cognitive Assessment (MoCA) score of 20 or higher
排除标准
- •Concurrent neurological conditions (e.g., stroke, seizures; dementia)
- •Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation
- •Use of psychotropic medications having adverse effect on mental/physical functioning
- •Severe, unpredictable motor fluctuations
- •Severe sleep difficulties.
研究组 & 干预措施
PD Drivers Using AV Technologies On-road
Each driver will drive on-road, everybody will be exposed to two drives (Drive 1, Drive 2) one drive with and the other without in-vehicle technology. The order of technology (with vs. without IVIS or ADAS) and the order of the routes (Drive 1 vs. Drive 2) will be randomly allocated to control for order effects.
干预措施: PD Drivers Using AV Technologies On-road (Other)
结局指标
主要结局
Type and number of driving errors
时间窗: 1 year up to study completion
Type of driving errors include: speeding, lane maintenance and signaling on-road recorded by the evaluator, or via vehicle recorded kinematics and telematics (e.g., in-vehicle GPS to record speed).
Total number of driving errors
时间窗: 1 year up to study completion
The evaluator will record the total number of driving errors by number and type (i.e., speeding, lane maintenance, and signaling) on a standardized data collection form.
次要结局
未报告次要终点