Low-Fidelity Driving Simulator Training and Driving Outcomes in Parkinson's Disease: A Pilot Randomized Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Driving performance - Standard Lane Deviation Position
Study Overview
Brief Summary
The goal of this clinical trial is to learn if low-fidelity driving simulator training works to improve cognitive performance, driving behavior, and driving aptitude in individuals with Parkinson's disease. The main questions it aims to answer are:
- Does low-fidelity driving simulator training improve cognitive performance?
- Does low-fidelity driving simulator training improve driving performance?
- Does low-fidelity driving simulator training improve driving aptitude?
Researchers will compare driving simulator training to no-training (waitlist control group) to see if the low-fidelity driving simulator is effective in individuals with Parkinson's disease.
Participants will:
- Undergo 10 sessions of driving simulator training or be placed in the no-training group.
- Training group participants will visit the driving simulator lab 2-3 times a week for 4 weeks for training.
- Paper-based tests and driving simulator tests will be done before and after 10 sessions of training (or a waiting period).
Detailed Description
Driving is an important activity of daily living for most people in the United States, including older adults. It is an integral part of mobility, independent living, and physical, social, and economic well-being. Parkinson's disease is the second most common neurodegenerative disease, and it is an important societal issue and global priority. A recent survey study has reported that 84% of pwPD held a driving license. Among pwPD holding a driving license, 15% reported being involved in a motor vehicle crash in the past 3 years. Another study reported that among pwPD involved in motor vehicle crashes, 11% of them were at-fault collisions, which raises safety concerns among drivers with PD.5 Several studies have established that pwPD exhibit impaired driving skills evaluated on driving simulator experiments and on-road tests. Despite the challenges associated with driving in persons with Parkinson's disease, it is indicated that they can learn specific tasks but require more practice than healthy controls. In this study, we attempt to evaluate the training effectiveness of a portable driving simulator in improving cognitive performance, driver behavior, and aptitude in pwPD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with Parkinson's disease diagnosed by a movement disorder specialist.
- •Diagnosis of PD was based on the UK Brain Bank Diagnostic Criteria.
- •Hoehn and Yahr stage 1 to 3 in the medication ON state with no troublesome dyskinesia.
- •Minimum binocular acuity of 20/40 or better at least in one eye according to the Kansas DMV statutes.
- •Montreal Cognitive Assessment (MoCA) ≥
- •Ambulates independently with or without walking aids.
- •Possess a valid driver's license.
Exclusion Criteria
- •Any concomitant neurological comorbidity, such as stroke, traumatic brain injury, or multiple sclerosis, that would hinder driving.
- •Atypical forms of Parkinsonism
- •History of substance abuse in the last 10 years.
- •History of uncontrolled psychiatric problems
- •Undergone deep brain stimulation or focused ultrasound treatment
- •Uncontrolled diabetes mellitus
Arms & Interventions
Training
Participants in the training arm will undergo 10 sessions of low-fidelity driving simulator training targeting different skills related to driving.
Intervention: Low-fidelity driving simulator training (Other)
Waitlist control
The waitlist control group will not undergo any training during the study period. They will be offered a short training after the study is complete.
Outcomes
Primary Outcomes
Driving performance - Standard Lane Deviation Position
Time Frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)
SDLP refers to the mean Lane position of the driver's vehicle to the roadway centerline (defined as zero). The center of the vehicle is the reference point. Positive values indicate lane positions on the right side of the road; negative values indicate left. Default roadway lane widths are 12 ft (3.66 m) across; therefore, values close to 6 ft (1.83 m) indicate positioning near the center of a lane.
Driving aptitude - The Adelaide Driving Self-Efficacy Scale
Time Frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)
The Adelaide Driving Self-Efficacy Scale is a self-reported assessment of participants' beliefs in their capability to organize and execute actions towards safe driving. It is a 12-item questionnaire that measures an individual's self-perceived confidence in performing various driving-related activities, such as driving in heavy traffic or at night. It uses a 0 (not confident at all) to 10 (completely confident) rating scale for each activity, with total scores indicating overall driving confidence.
Secondary Outcomes
- Driving performance - Driver errors.(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Montreal Cognitive Assessment(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Dot cancellation test errors(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Rey-Osterrieth Complex Figure Copy(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Trail Making Tests A & B(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Snellgrove Maze Task(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Cognitive performance - Stroke Driver Screening Assessment (US version)(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving performance - Divided attention(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving performance - Time to Collision(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving Performance - Navigating Intersections(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving performance - Complex Brake Reaction Time(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving performance - The Test Ride for Investigating Practical Fitness to Drive driving simulator score(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving aptitude - Driver Comfort Questionnaire(Baseline (pre-intervention) and at 4 weeks (post-intervention))
- Driving aptitude - Driving and Riding Avoidance Scale(Baseline (pre-intervention) and at 4 weeks (post-intervention))
Investigators
Abiodun Akinwuntan, Ph.D., MPH, MBA, FASAHP
Professor and Dean, School of Health Professions
University of Kansas Medical Center