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

NCT07463755 | Not Yet Recruiting

• 1 other identifier: STUDY00161777
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease (PD)

Keywords

Low-fidelity driving simulator; Parkinson's disease; Cognitive performance; Driving performance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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)

Other Outcomes (1)

• Daily Driving Log

  Baseline (pre-intervention) and at 4 weeks (post-intervention)

Study Arms (2)

Training

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

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.

Interventions

Low-fidelity driving simulator training OTHER

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.

Training

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

Mobility and Falls Lab

Kansas City, Kansas, 66103, United States

Location

Related Publications (11)

• 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.

  PMID: 16186521 BACKGROUND

• 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.

  PMID: 20944662 BACKGROUND

• 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.

  PMID: 17909156 BACKGROUND

• 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.

  PMID: 15654027 BACKGROUND

• 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.

  PMID: 19805726 BACKGROUND

• 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.

  PMID: 15747369 BACKGROUND

• 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.

  PMID: 15726539 BACKGROUND

• 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.

  PMID: 34542030 BACKGROUND

• 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.

  PMID: 24976103 BACKGROUND

• 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.

  PMID: 17082464 BACKGROUND

• 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.

  PMID: 14636668 BACKGROUND

Central Study Contacts

Abiodun E Akinwuntan, Ph.D.

CONTACT

913-588-5235; aakinwuntan@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean, School of Health Professions

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: March 11, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)