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

Sponsor
Western University, Canada (Other)
Overall Status
Recruiting
CT.gov ID
NCT03195608
Collaborator
(none)
24
1
2
44.6
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lane change assistance system
  • Behavioral: Active Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessor will be masked regarding the pre or post-test status of the assessment.
Primary Purpose:
Device Feasibility
Official Title:
Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
Actual Study Start Date :
Apr 15, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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
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.

Active Comparator: 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.

Behavioral: Active Control
Participants will practice their driving on a driving simulator with feedback form a trained interventionist.
Other Names:
  • Simulator practice
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Western Ontario London Ontario Canada N6G1H1

    Sponsors and Collaborators

    • Western University, Canada

    Investigators

    • Principal Investigator: Liliana Alvarez, PhD, University of Western Ontario, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liliana Alvarez Jaramillo, Assistant Professor, Western University, Canada
    ClinicalTrials.gov Identifier:
    NCT03195608
    Other Study ID Numbers:
    • 109272
    First Posted:
    Jun 22, 2017
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liliana Alvarez Jaramillo, Assistant Professor, Western University, Canada
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2021