NCT03969927 User-friendliness of a Portable Driving Simulator
| NCT ID | NCT03969927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-08-28 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2019-08-28 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of a first ever stroke, PD, or MS * Valid driver's licenses, ≥ 3 years driving experience, * Mini-mental State Examination score ≥24, and * Binocular acuity of at least 20/60 in compliance with state of Kansas driving laws Exclusion Criteria: \- Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.
Contact & Investigator
Abiodun Akinwuntan, PhD, MPH MBA
PRINCIPAL INVESTIGATOR
University of Kansas School of Health Professions
Frequently Asked Questions
Who can join the NCT03969927 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03969927 currently recruiting?
Yes, NCT03969927 is actively recruiting participants. Contact the research team at aakinwuntan@kumc.edu for enrollment information.
Where is the NCT03969927 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT03969927 clinical trial?
NCT03969927 is sponsored by University of Kansas Medical Center. The principal investigator is Abiodun Akinwuntan, PhD, MPH MBA at University of Kansas School of Health Professions. The trial plans to enroll 30 participants.
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