Low-Fidelity Driving Simulator Training in Parkinson's Disease.

Low-Fidelity Driving Simulator Training and Driving Outcomes in Parkinson's Disease: A Pilot Randomized Control Study

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Other: Low-fidelity driving simulator training

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abiodun E Akinwuntan, Ph.D.; Phone Number: 711 TTY 913-588-5235; Email: aakinwuntan@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Mobility and Falls Lab
      • Contact: Samuel K Durairaj, MPT; Phone Number: 913-326-7999; Email: sdurairaj@kumc.edu
      • Principal Investigator: Abiodun E Akinwuntan, Ph.D.
      • Sub-Investigator: Hannes Devos, PhD
      • Sub-Investigator: Samuel K Durairaj, MPT
      • Sub-Investigator: Kelly Lyons, PhD
      • Sub-Investigator: Jianghua He, PhD
      • Sub-Investigator: Linda D'Silva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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) ≥ 20.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training; Participants in the training arm will undergo 10 sessions of low-fidelity driving simulator training targeting different skills related to driving.	Other: Low-fidelity driving simulator training; Participants in the treatment group will undergo 10 sessions of training on a low-fidelity driving simulator. Each session will last approximately 45-60 minutes. There will be 2-3 sessions each week for 4 weeks.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving performance - Standard Lane Deviation Position	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.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving aptitude - The Adelaide Driving Self-Efficacy Scale	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.	Baseline (pre-intervention) and at 4 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance - Montreal Cognitive Assessment	The Montreal Cognitive Assessment is a brief screening tool used to detect mild cognitive impairment and early dementia. It evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. Total score is 30 points. > or = 26 ---- Normal 18 to 25 ----- Mild cognitive impairment	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Cognitive performance - Dot cancellation test errors	The Dot Cancellation Test is a neuropsychological evaluation tool used to assess focus, attention, visual scanning, and occasionally motor speed or neglect. It is also referred to as the Cancellation Test or Visual Cancellation Task. The participant is given a page with a random cluster of dots and instructed to cross out (cancel) a particular type of cluster of dots. The investigator calculates the time taken and the number of errors committed by the participant.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Cognitive performance - Rey-Osterrieth Complex Figure Copy	The Rey-Rey-Osterrieth Complex Figure Copy Test is a neuropsychological tool used to assess visuospatial constructional ability, planning, and organizational skills. The individual is asked to copy a complex geometric figure, and their drawing is scored based on the accuracy and placement of 18 specific design components. The score ranges from 0 to 36. A higher score indicates better performance.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Cognitive performance - Trail Making Tests A & B	The Trail Making Test is a paper-and-pencil assessment used to measure attention, processing speed, and executive function. It has two parts: TMT-A, where individuals connect numbers in sequence (1-25), primarily tests visual scanning and processing speed. TMT-B requires alternating between numbers and letters in order (1-A-2-B, etc.), placing greater demand on cognitive flexibility and set-shifting.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Cognitive performance - Snellgrove Maze Task	The Snellgrove Maze Task is a paper-and-pencil test designed to screen for cognitive and executive function impairments that may affect safe driving. The participant is asked to navigate a complex maze as quickly and accurately as possible without lifting the pencil from the page. Performance is measured by time to completion and number of errors (e.g., wrong turns, dead ends). Longer times and higher error counts are associated with poorer executive function.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Cognitive performance - Stroke Driver Screening Assessment (US version)	The Stroke Driver Screening Assessment (SDSA) is a standardized battery of paper-and-pencil tests developed to predict fitness to drive after stroke or other brain injuries. It includes subtests such as Dot Cancellation (visual attention), Directions Test (visuospatial and executive skills), Road Sign Recognition (memory and comprehension), and Compass Test (spatial orientation).	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving performance - Divided attention	Divided attention in simulator evaluations refers to a driver's ability to manage driving tasks while simultaneously responding to secondary demands, such as detecting shapes. Performance is typically measured by reaction time, accuracy of responses, and driving stability (lane keeping, speed control) during the dual-task condition. Poor divided attention scores suggest reduced cognitive flexibility and higher crash risk.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving performance - Time to Collision	Time to Collision is a safety metric in driving simulator evaluations that estimates how long it would take for a driver to collide with a lead vehicle or hazard if both maintained their current speed and trajectory. A shorter TTC indicates less available reaction time and a higher crash risk. Critical thresholds (often ≤ 1.5-2.0 seconds) are used to identify unsafe or delayed responses.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving Performance - Navigating Intersections	Navigating intersections in simulator evaluations assesses a driver's ability to manage visual scanning, hazard perception, decision-making, and vehicle control while navigating an intersection. The performance is measured by gap acceptance.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving performance - Complex Brake Reaction Time	Complex Brake Reaction Time in simulator evaluations measures how quickly a driver can detect an unexpected hazard, process the situation, and apply the brake in a more demanding context. Longer Complex Brake Reaction Time indicates delayed hazard response and higher crash risk.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving performance - Driver errors.	Driver mistakes, such as the number of collisions, the number of lane positioning errors, total number of tickets, will be recorded during the simulator drive assessment. Higher scores indicate poor driving performance.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving performance - The Test Ride for Investigating Practical Fitness to Drive driving simulator score	The Test Ride for Investigating Practical Fitness to Drive is a structured driving simulator assessment developed to evaluate the practical fitness to drive of older adults and individuals with medical conditions. Total items are 49 scored on an ordinal scale of 1-4. Total score is 196. A higher score indicates better driving performance.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving aptitude - Driver Comfort Questionnaire	The Driver Comfort Questionnaire is a self-report questionnaire designed to assess how comfortable and confident individuals feel in different driving situations. It is scored between 0 and 100 percent. A higher score indicates a higher comfort level of driving.	Baseline (pre-intervention) and at 4 weeks (post-intervention)
Driving aptitude - Driving and Riding Avoidance Scale	The Driving and Riding Avoidance Scale is a questionnaire that measures the extent to which individuals avoid certain driving or riding situations due to discomfort, anxiety, or reduced confidence. There are 20 items in this questionnaire. Each item is scored 0-4. A lower score indicates less avoidance behavior.	Baseline (pre-intervention) and at 4 weeks (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Driving Log	A self-reported Daily Driving Log, manually entered in a journal by each participant, will be collected to analyze driving patterns during the study period.	Baseline (pre-intervention) and at 4 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Publications and helpful links

General Publications

• Redgrave P, Rodriguez M, Smith Y, Rodriguez-Oroz MC, Lehericy S, Bergman H, Agid Y, DeLong MR, Obeso JA. Goal-directed and habitual control in the basal ganglia: implications for Parkinson's disease. Nat Rev Neurosci. 2010 Nov;11(11):760-72. doi: 10.1038/nrn2915. Epub 2010 Oct 14.
• Meindorfner C, Korner Y, Moller JC, Stiasny-Kolster K, Oertel WH, Kruger HP. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005 Jul;20(7):832-42. doi: 10.1002/mds.20412.
• Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. doi: 10.1212/01.wnl.0000247740.47667.03. Epub 2006 Nov 2.
• Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.
• Akinwuntan AE, De Weerdt W, Feys H, Pauwels J, Baten G, Arno P, Kiekens C. Effect of simulator training on driving after stroke: a randomized controlled trial. Neurology. 2005 Sep 27;65(6):843-50. doi: 10.1212/01.wnl.0000171749.71919.fa.
• Devos H, Vandenberghe W, Nieuwboer A, Tant M, Baten G, De Weerdt W. Predictors of fitness to drive in people with Parkinson disease. Neurology. 2007 Oct 2;69(14):1434-41. doi: 10.1212/01.wnl.0000277640.58685.fc.
• Wood JM, Worringham C, Kerr G, Mallon K, Silburn P. Quantitative assessment of driving performance in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):176-80. doi: 10.1136/jnnp.2004.047118.
• Uc EY, Rizzo M, Anderson SW, Dastrup E, Sparks JD, Dawson JD. Driving under low-contrast visibility conditions in Parkinson disease. Neurology. 2009 Oct 6;73(14):1103-10. doi: 10.1212/WNL.0b013e3181bacf6e.
• Stolwyk RJ, Triggs TJ, Charlton JL, Iansek R, Bradshaw JL. Impact of internal versus external cueing on driving performance in people with Parkinson's disease. Mov Disord. 2005 Jul;20(7):846-57. doi: 10.1002/mds.20420.
• Brock P, Oates LL, Gray WK, Henderson EJ, Mann H, Haunton VJ, Skelly R, Hand A, Davies ML, Walker RW. Driving and Parkinson's Disease: A Survey of the Patient's Perspective. J Parkinsons Dis. 2022;12(1):465-471. doi: 10.3233/JPD-212686.
• Collia DV, Sharp J, Giesbrecht L. The 2001 National Household Travel Survey: a look into the travel patterns of older Americans. J Safety Res. 2003;34(4):461-70. doi: 10.1016/j.jsr.2003.10.001.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive performance; Driving performance; Parkinson's disease; Low-fidelity driving simulator
• Other Study ID Numbers: STUDY00161777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a non-federal pilot study. Sharing IDP will be considered if any request is made after publication in a journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No