Back to results

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

Primary Purpose

Parkinson Disease, Driving Impaired

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lane change assistance system

Active Control

About this trial

This is an interventional device feasibility trial for Parkinson Disease focused on measuring In-vehicle technologies, Parkinson's disease, Driving performance

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Western OntarioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03195608

First Posted

June 16, 2017

Last Updated

April 5, 2021

Sponsor

Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT03195608

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 15, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Driving Impaired

Keywords

In-vehicle technologies, Parkinson's disease, Driving performance

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcomes assessor will be masked regarding the pre or post-test status of the assessment.

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Lane change assistance system

Intervention Description

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

Behavioral

Intervention Name(s)

Active Control

Other Intervention Name(s)

Simulator practice

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

Description

Refers to the lateral position of the vehicle in the lane.

Time Frame

Baseline, 4 weeks, and 6 weeks

Title

Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

Description

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

Time Frame

Baseline, 4 weeks, and 6 weeks

Title

Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)

Description

Refers to the proper use of turning signals during lane changes

Time Frame

Baseline, 4 weeks, and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liliana Alvarez, PhD

Phone

5196612111

Ext

88957

lalvare2@uwo.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liliana Alvarez, PhD

Organizational Affiliation

University of Western Ontario, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Western Ontario

City

London

State/Province

Ontario

ZIP/Postal Code

N6G1H1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Colonna, BSc

Phone

5196612111

Ext

88964

rcolonna@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs