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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "A recent survey study has reported that 84% of pwPD held a driving license."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether training on a simple driving simulator helps people with Parkinson's disease improve their thinking skills and driving ability. Researchers will compare people who complete 10 training sessions over 4 weeks with people who wait without training. Both groups will take paper tests and driving simulator tests before and after this period.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson's disease diagnosed by a movement disorder specialist using UK Brain Bank rules.
- Have Parkinson's at stage 1 to 3 on the Hoehn and Yahr scale while medicine is working, with no troublesome movements you cannot control.
- Have vision of 20/40 or better in at least one eye, as required by Kansas driving rules.
- Score at least 20 on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.
- Can walk on your own, with or without a walking aid.
- Have a valid driver's license.
Who can't join
- Have another brain or nerve condition, such as a stroke, brain injury, or multiple sclerosis, that would make driving harder.
- Have an unusual form of parkinsonism, a condition with symptoms like Parkinson's disease.
- Have a history of drug or alcohol abuse in the past 10 years.
- Have a history of mental health problems that are not controlled.
- Have had deep brain stimulation, which uses electrical signals in the brain, or focused ultrasound treatment, which uses sound waves.
- Have diabetes that is not controlled.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
KS
- Mobility and Falls Lab · Kansas City, KS 66103Samuel K Durairaj, MPT · Study contact · 913-326-7999 · sdurairaj@kumc.eduAbiodun E Akinwuntan, Ph.D. · Principal investigatorHannes Devos, PhD · Sub-investigatorSamuel K Durairaj, MPT · Sub-investigatorMore trials in Kansas City