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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Driving performance - Standard Lane Deviation Position [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving aptitude - The Adelaide Driving Self-Efficacy Scale [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]

Secondary outcome measures (12)

• Cognitive performance - Montreal Cognitive Assessment [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Cognitive performance - Dot cancellation test errors [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Cognitive performance - Rey-Osterrieth Complex Figure Copy [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Cognitive performance - Trail Making Tests A & B [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Cognitive performance - Snellgrove Maze Task [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Cognitive performance - Stroke Driver Screening Assessment (US version) [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving performance - Divided attention [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving performance - Time to Collision [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving Performance - Navigating Intersections [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving performance - Complex Brake Reaction Time [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving performance - Driver errors. [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]
• Driving performance - The Test Ride for Investigating Practical Fitness to Drive driving simulator score [Time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Mobility and Falls Lab — Kansas City

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07463755 · STUDY00161777

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗