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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PD Drivers Using AV Technologies On-road
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Parkinson Disease, In-vehicle information system, Advanced driver assistance system

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UF Norman Fixel Institute for Neurological DiseasesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD Drivers Using AV Technologies On-road

Arm Description

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.

Outcomes

Primary Outcome Measures

Total number of driving errors
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.
Type and number of driving errors
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).

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
December 21, 2022
Sponsor
University of Florida
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT04660500
Brief Title
Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Official Title
Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, In-vehicle information system, Advanced driver assistance system

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD Drivers Using AV Technologies On-road
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
PD Drivers Using AV Technologies On-road
Intervention Description
All drives will include events to assess the impact of in-vehicle information systems (IVIS) and advanced driver assistance systems (ADAS) on the driving performance (driving errors) of drivers with PD. For IVIS the investigators will include options to assess errors with lane maintenance (with and without the lane departure warning system) and signaling (with and without blind spot detection). For ADAS the investigators will include conditions to assess errors in speeding (with and without adaptive cruise control) and lane exceedances (with and without lane keeping assist).
Primary Outcome Measure Information:
Title
Total number of driving errors
Description
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.
Time Frame
1 year up to study completion
Title
Type and number of driving errors
Description
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).
Time Frame
1 year up to study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Jeghers
Phone
352-273-6043
Email
mjeghers@phhp.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherrilene Classen, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Norman Fixel Institute for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adolfo Ramirez-Zamora
Phone
352-294-5400

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35812823
Citation
Classen S, Li Y, Giang W, Winter S, Wei J, Patel B, Jeghers M, Gibson B, Rogers J, Ramirez-Zamora A. RCT protocol for driving performance in people with Parkinson's using autonomous in-vehicle technologies. Contemp Clin Trials Commun. 2022 Jun 28;28:100954. doi: 10.1016/j.conctc.2022.100954. eCollection 2022 Aug.
Results Reference
derived

Learn more about this trial

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

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