Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Type and number of driving errors
Study Overview
Brief Summary
For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help mitigate functional deficits, improve driving performance, decrease driving errors and enhance their ability to stay on the road. Using a pretest/posttest design the investigators will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide recommendations to drivers with PD, the clinical community and industry.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25
- •Has mild or moderate disease severity, based on the MDS-Unified Parkinson's Disease Rating Scale for motor symptoms (hereafter referred to as the UPDRS section 3) in the on state of medications (i.e., one hour of taking PD medications) and the Modified Hoehn and Yahr disease severity scale
- •Is representative of one of two PD groups based on age, i.e., participants with symptom onset between 35-64 years of age (younger onset), or participants with symptom onset between ages 65- 85 years (older onset)
- •Currently driving with a valid license
- •Meets the Florida state requirement for visual acuity of at least 20/50 in one eye, if one eye is blind or 20/200 or worse the other eye must be 20/40 or better (20/40 in at least one eye) and field of vision (130 degrees or more)
- •Lives independently in the community
- •Proficient in reading/speaking English
- •A Montreal Cognitive Assessment (MoCA) score of 20 or higher
Exclusion Criteria
- •Concurrent neurological conditions (e.g., stroke, seizures; dementia)
- •Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation
- •Use of psychotropic medications having adverse effect on mental/physical functioning
- •Severe, unpredictable motor fluctuations
- •Severe sleep difficulties.
Arms & Interventions
PD Drivers Using AV Technologies On-road
Each driver will drive on-road, everybody will be exposed to two drives (Drive 1, Drive 2) one drive with and the other without in-vehicle technology. The order of technology (with vs. without IVIS or ADAS) and the order of the routes (Drive 1 vs. Drive 2) will be randomly allocated to control for order effects.
Intervention: PD Drivers Using AV Technologies On-road (Other)
Outcomes
Primary Outcomes
Type and number of driving errors
Time Frame: 1 year up to study completion
Type of driving errors include: speeding, lane maintenance and signaling on-road recorded by the evaluator, or via vehicle recorded kinematics and telematics (e.g., in-vehicle GPS to record speed).
Total number of driving errors
Time Frame: 1 year up to study completion
The evaluator will record the total number of driving errors by number and type (i.e., speeding, lane maintenance, and signaling) on a standardized data collection form.
Secondary Outcomes
No secondary outcomes reported