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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195608
• Other study ID #: 109272
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Driving Impaired
• Parkinson Disease

Intervention

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.

Behavioral:
• Active Control
Participants will practice their driving on a driving simulator with feedback form a trained interventionist.

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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