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Parkinson's Disease (PD)NCT07463755

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

A study testing Low-fidelity driving simulator training in people with Parkinson's Disease (PD), run by University of Kansas Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
Low-fidelity driving simulator training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
15 Apr 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abiodun E Akinwuntan, Ph.D. contact

913-588-5235 ext. 711 TTY

aakinwuntan@kumc.edu

United States1 site
  • Mobility and Falls Lab

    Kansas City, Kansas, 66103

    Samuel K Durairaj, MPT, 913-326-7999, sdurairaj@kumc.edu

    Abiodun E Akinwuntan, Ph.D.

Other trials in United States

About this study

Official title: 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?
Read more

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).
Read the 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.

Being tested
Low-fidelity driving simulator training
Keywords
Low-fidelity driving simulator, Parkinson's disease, Cognitive performance, Driving performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-fidelity driving simulator trainingOther

    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.

Study groups in NCT07463755
Study groupRoleWhat they receive
TrainingExperimentalParticipants in the training arm will undergo 10 sessions of low-fidelity driving simulator training targeting different skills related to driving.
Receives: Other: Low-fidelity driving simulator training
Waitlist controlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (14)
  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07463755
Sponsor's protocol ID
STUDY00161777
Status last verified
Mar 2026
First submitted
17 Sep 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a non-federal pilot study. Sharing IDP will be considered if any request is made after publication in a journal.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34542030
  • 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.

    PubMed 24976103
  • 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.

    PubMed 17082464
  • 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.

    PubMed 14636668

Questions about this trial

What is this clinical trial studying?

A study testing Low-fidelity driving simulator training in people with Parkinson's Disease (PD), run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abiodun E Akinwuntan, Ph.D. (913-588-5235 ext. 711 TTY, aakinwuntan@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Driving performance - Standard Lane Deviation Position (time frame: Baseline (pre-intervention) and at 4 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07463755, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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