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

NCT ID: NCT03195608

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Lane change assistance system

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

Active Control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Simulator practice

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Liliana Alvarez Jaramillo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liliana Alvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

University of Western Ontario

London, Ontario, Canada

Countries

Canada

Other Identifiers

109272

Identifier Type: -

Identifier Source: org_study_id