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

NCT03195608 | Completed

• 1 other identifier: 109272
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Driving Impaired

Keywords

In-vehicle technologies; Parkinson's disease; Driving performance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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.

Intervention

Active Control BEHAVIORAL

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

Also known as: Simulator practice

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

University of Western Ontario

London, Ontario, N6G1H1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Liliana Alvarez, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be masked regarding the pre or post-test status of the assessment.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 22, 2017
• Study Start: April 15, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)