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OpenTrials
Completed

NCT Number: NCT03195608

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Driving Impaired Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Western Ontario

London, Ontario, N6G1H1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lane change assistance system

Device

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 Control

Behavioral

Participants will practice their driving on a driving simulator with feedback form a trained interventionist.

Other names: Simulator practice

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: Baseline, 4 weeks, and 6 weeks

    Refers to the proper use of turning signals during lane changes

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2017
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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