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

Not Applicable

Completed

• Conditions: Parkinson Disease; Driving Impaired
• Interventions: Device: Lane change assistance system; Behavioral: Active Control

• Registration Number: NCT03195608
• Lead Sponsor: Western University, Canada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Study Start: 2019-04-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Lane change assistance system	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).
Control	Active Control	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.

Primary Outcome Measures

Name	Time	Method
Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)	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)	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)	Baseline, 4 weeks, and 6 weeks	Refers to the proper use of turning signals during lane changes

Trial Locations

Locations (1)

University of Western Ontario; 🇨🇦 London, Ontario, Canada