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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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). |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lane change assistance system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liliana Alvarez, PhD | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Western Ontario | London | Ontario | N6G1H1 | Canada |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Outcomes assessor will be masked regarding the pre or post-test status of the assessment.
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| Active Control | Behavioral | Participants will practice their driving on a driving simulator with feedback form a trained interventionist. |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |