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Parkinson DiseaseNCT03969927

User-friendliness of a Portable Driving Simulator

A study testing Low-Fidelity PDS and High Fidelity Fixed-Base Simulator in people with Parkinson Disease and Multiple Sclerosis, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Parkinson Disease, Multiple Sclerosis, Stroke
What is being tested?
Low-Fidelity PDS and High Fidelity Fixed-Base Simulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
28 Aug 2019to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Abiodun Akinwuntan

    Kansas City, Kansas, 66160-8500

Other trials in United States

About this study

Official title: User-friendliness of a Portable Driving Simulator to Retrain Impaired Driving Skills in Stroke Survivors and in Individuals With Parkinson's Disease and Multiple Sclerosis

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.

Read more

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.

Read the detailed description

Aims: The aims of the proposed study are to determine (1) the ease of use and development of simulator sickness while operating the low fidelity Portable Driving Simulator (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, persons with Parkinson's Disease (PD) or multiple sclerosis (MS) in a high-fidelity fixed-base simulator.

Hypotheses: For the first study aim 1, the investigators hypothesize that the simple set up of the PDS will make it easier to use and better mitigate incidence of simulator sickness that typically leads to attrition than in a high-fidelity simulator.

For study aim 2, 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.

Background: Currently, simulator-based training is the method with the best evidence of retraining impaired driving-related skills after stroke and with promise in individuals with Parkinson's disease (PD) or multiple sclerosis (MS). Driving simulators enable patients to retrain impaired driving skills in a context that evokes and ''mimics'' the perceptual, cognitive, and motor processes used in real-world driving. The fact that real-world traffic and driving situations can be presented many times over, without any safety risk, under full experimenter or clinician control, and with ''instant replay'' possibility to augment feedback enhances the utility of the driving simulator as an ideal tool for driving rehabilitation.

However, the use of simulators to retrain driving skills of patients with stroke, PD, or MS has been very limited because of three major reasons. The cost of currently available driving simulators (between $50,000 to $500,000), the space needed to house the simulators (15 to 50 square feet), and the incidence of simulator sickness (rate = 5 - 25%) in high-fidelity simulators. The principal investigator recently developed a low cost ($10,000) low fidelity portable driving simulator (PDS) in the University of Kansas Laboratory for Advanced Rehabilitation Research in Simulation (LARRS) that measures 25.5" Wide, 32.5" High, and 25" Deep and requires only approximately 4 square feet of space.

Study Objectives:

  1. Determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting.
  2. Determine the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator.

Study Procedures: The study team will recruit 10 participants with a first ever stroke, 10 participants with PD (Hoehn \& Yahr stage 2 or 3 during on-medication) and 10 participants with MS (Expanded Disability Status Scale between 3 and 6.5). Participants in each diagnosis group will be randomly allocated, based on a computer generated random sequence, into either the PDS or high-fidelity simulator training. The randomization process will be done by principal investigator. All participants will undergo a pre-training evaluation that includes driving-related physical, visual, and cognitive tests. Studies have shown that a minimum of five hours of training in a simulator is needed for meaningful improvement in driving skills. As such, each participant will receive five hours of the assigned training. The first session in the simulator will establish participants' baseline driving performance. The next three training sessions will be directed at addressing the deficits in specific skills identified from the baseline performance. The fifth session in the simulator will establish participants' post-training driving performance. All participants will again undergo a post-training evaluation similar to the pre-training evaluation. The five training sessions in the simulator will each last approximately one hour per day, twice or thrice a week, and will be completed in two weeks. The study coordinator, who will be blind to participants' group allocation, will administer both the pre- and post-training evaluations. A research student in the Laboratory for Advanced Rehabilitation Research in Simulation supervised by Dr. Hannes Devos and Dr. Abiodun Akinwuntan will train all participants.

Being tested
Low-Fidelity PDS, High Fidelity Fixed-Base Simulator
Keywords
Simulation, Driving Simulation
Medical subject headings
Parkinson Disease, Multiple Sclerosis, Stroke

What participants receive

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

  • Low-Fidelity PDSDevice

    Also called Portable Driving Simulator

    The principal investigator recently developed a low cost ($10,000) low fidelity portable driving simulator (PDS) in the University of Kansas Laboratory for Advanced Rehabilitation Research in Simulation (LARRS) that measures 25.5" Wide, 32.5" High, and 25" Deep and requires only approximately 4 square feet of space.

    This intervention uses the PDS to retrain study participants and improve their driving related skills.

  • High Fidelity Fixed-Base SimulatorDevice

    This intervention uses the large high-fidelity fixed-base driving simulator to retrain study participants and improve their driving related skills.

Study groups in NCT03969927
Study groupRoleWhat they receive
Low-Fidelity PDS TrainingExperimentalIndividuals with stroke, PD, or MS
Receives: Device: Low-Fidelity PDS
High Fidelity Fixed-Base Simulator TrainingActive comparatorIndividuals with stroke, PD, or MS
Receives: Device: High Fidelity Fixed-Base Simulator

What is being measured

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

  1. User-Friendliness

    User-Friendliness will be assessed using a User-Friendliness Survey which is a Likert scale. [1-5 scale with 1 representing the lowest degree of user-friendliness and 5 representing the highest degree of user-friendliness]

    Measured: Assessed at the End of visit 2, visit 3, and visit 4. These visits will take place over an average of one week.

  2. Simulator Sickness

    Simulator Sickness and symptoms of Simulator Sickness will be assessed using questionnaire adapted from the 1993 Kennedy et al Simulator Sickness Questionnaire. [This will be reported from a 0-228.14 scale with 0 representing the lowest possible degree of Simulator Sickness and 228.14 indicating the greatest possible degree of Simulator Sickness]

    Measured: Assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. These visits will take place over an average of one week.

  3. Driving Performance

    Driving Performance will be assessment by a Driving rehabilitation specialist before and after each participant undergoes training. The participants will be tested on the high-fidelity driving simulator and the driving simulator provide objective measurements of lane position maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time.

    Measured: Assessed during visit 1, and visit 5. These visits will take place over an average of one week.

Timeline

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

  1. First posted31 May 2019
  2. Study start28 Aug 2019
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969927
Sponsor's protocol ID
STUDY00142927
Status last verified
Jun 2025
First submitted
25 May 2019
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data generated during the project will be entered into a secure REDCap database. This database will be housed on a secure network drive that is routinely backed-up to an offsite data storage location. Upon completion of the project, all data will be de-identified and available for other investigators at their request, in compliance with the NIH guidelines. The study team does not anticipate unique resources will be developed and thus are not providing a plan for resource sharing Sharing Model Organisms: Generation of new model organisms is not anticipated for this project. Genome-Wide Association Studies (GWAS): This project does not include a genome-wide association study.

Questions about this trial

What is this clinical trial studying?

A study testing Low-Fidelity PDS and High Fidelity Fixed-Base Simulator in people with Parkinson Disease and Multiple Sclerosis, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User-Friendliness (time frame: Assessed at the End of visit 2, visit 3, and visit 4. These visits will take place over an average of one week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Aug 2026.

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