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临床试验/NCT03195608
NCT03195608已完成不适用

Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease

Western University, Canada2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

研究概览

简要总结

Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that increase the crash risk in this population. Current vehicle automation technologies are available, that although designed for the general public, may help drivers with PD stay on the roads longer and safer than currently possible. Using a driving simulator (a safe and cost-effective alternative with no impact on licensing for participants), this study will investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology (i.e., a simulated lane change assistance system) to address critical driving errors in individuals with mild to moderate Parkinson's disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will be masked regarding the pre or post-test status of the assessment.

入排标准

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

入选标准

  • Participants must be 21 years of age or older (as a feasibility study, this study will provide the opportunity to participate to those diagnosed with early onset PD)
  • Have been diagnosed with Parkinson's disease by a neurologist or movement disorder specialist
  • Currently hold a valid G driver's license
  • Meet provincial visual acuity (20/50 binocular) and visual field (120 continuous along the horizontal meridian with both eyes examined together) requirements for driving
  • Be proficient in English reading and speaking (self-reported).

排除标准

  • Have any other neurological or psychiatric conditions that would interfere with full participation in the study
  • Be taking psychotropic medication(s) that affect their mental and/or physical functioning

结局指标

主要结局

Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

时间窗: Baseline, 4 weeks, and 6 weeks

Refers to the lateral position of the vehicle in the lane.

Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

时间窗: Baseline, 4 weeks, and 6 weeks

Visual scanning is defined as eye movement and turning of the neck and head (e.g. glances, look sideways at an intersection, look at mirrors) to detect oncoming objects

Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

时间窗: Baseline, 4 weeks, and 6 weeks

Refers to the proper use of turning signals during lane changes

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liliana Alvarez Jaramillo

Assistant Professor

Western University, Canada

研究点 (2)

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