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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease, Driving Impaired

Intervention / Treatment
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* Device: Lane change assistance system
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will complete a standardized battery of paper and pencil and computer tests. Following these tests, participants will complete a baseline simulator driving assessment without any form of assistive technology. We will employ a CDS-200 driving simulator (DriveSafety Inc., Salt Lake City, UT). A trained blinded evaluator will observe the recorded drive and score the drive. After the baseline assessment, participants will engage in 3 intervention sessions (lasting 30 minutes each). During these sessions, the lane change assistance system will be introduced and participants will be taught how to use it. After the 3 sessions, participants will participate in a post-test, similar to the baseline assessment but with a different route within the simulated world. They will drive this new route with the assistive technology. One to two weeks after the post-test, participants will be invited to participate in a follow-up assessment (battery of tests and simulator assessment). | Device: Lane change assistance system<br>* This study will investigate the feasibility and preliminary efficacy of a 6-session lane change ADAS-intervention on the simulated driving performance of individuals with mild to moderate PD. We anticipate that the use of lane change assist technology will decrease the number of driving errors in individuals with PD. As this is a feasibility study, we will evaluate: -recruitment capability and sample characteristics - data collection methods, procedures, and outcome measures - acceptability and suitability of the lane change assist technology intervention - preliminary efficacy The outcomes of this study will inform the design of a larger study, should such large-scale study be warranted.<br>|
| Active Comparator: Control<br>Participants will complete a standardized battery of paper and pencil and computer tests. Following these tests, participants will complete a baseline simulator driving assessment without any form of assistive technology. We will employ a CDS-200 driving simulator (DriveSafety Inc., Salt Lake City, UT). A trained blinded evaluator will observe the recorded drive and score the drive. After the baseline assessment, participants will engage in 3 intervention sessions (lasting 30 minutes each). During these sessions, participants will drive the scenario and receive feedback from a trained evaluator regarding their live performance. No lane change assistance system will be utilized. After the 3 sessions, participants will participate in a post-test, similar to the baseline assessment but with a different route within the simulated world. | Behavioral: Active Control<br>* Participants will practice their driving on a driving simulator with feedback form a trained interventionist.<br>* Other names: Simulator practice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks) | Refers to the lateral position of the vehicle in the lane. | Baseline, 4 weeks, and 6 weeks | 
| Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (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 | Baseline, 4 weeks, and 6 weeks | 
| Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks) | Refers to the proper use of turning signals during lane changes | Baseline, 4 weeks, and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-vehicle technologies, Parkinson's disease, Driving performance