Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: PD Drivers Using AV Technologies On-road

• Registration Number: NCT04660500
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-09
• Study Start: 2021-01-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25
2. 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
3. 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)
4. Currently driving with a valid license
5. 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)
6. Lives independently in the community
7. Proficient in reading/speaking English
8. A Montreal Cognitive Assessment (MoCA) score of 20 or higher

Exclusion Criteria

1. Concurrent neurological conditions (e.g., stroke, seizures; dementia)
2. Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation
3. Use of psychotropic medications having adverse effect on mental/physical functioning
4. Severe, unpredictable motor fluctuations
5. Severe sleep difficulties.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD Drivers Using AV Technologies On-road	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.

Primary Outcome Measures

Name	Time	Method
Type and number of driving errors	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	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.

Trial Locations

Locations (1)

UF Norman Fixel Institute for Neurological Diseases; 🇺🇸 Gainesville, Florida, United States