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.
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.
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:
- Determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting.
- 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.
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke
- 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 group | Role | What they receive |
|---|---|---|
| Low-Fidelity PDS Training | Experimental | Individuals with stroke, PD, or MS Receives: Device: Low-Fidelity PDS |
| High Fidelity Fixed-Base Simulator Training | Active comparator | Individuals 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.
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.
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.
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.
- First posted31 May 2019
- Study start28 Aug 2019
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abiodun Akinwuntan, PhD, MPH MBA, Principal investigator, University of Kansas School of Health Professions
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03969927
- Acronym / sponsor ID
- STUDY00142927
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke
- Keywords
- Simulation, Driving Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Fidelity PDS Training | Experimental | Device: Low-Fidelity PDSIndividuals with stroke, PD, or MS |
| High Fidelity Fixed-Base Simulator Training | Active comparator | Device: High Fidelity Fixed-Base SimulatorIndividuals with stroke, PD, or MS |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Fidelity PDSAlso: Portable Driving SimulatorThe 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. | Device | Low-Fidelity PDS Training |
| High Fidelity Fixed-Base SimulatorThis intervention uses the large high-fidelity fixed-base driving simulator to retrain study participants and improve their driving related skills. | Device | High Fidelity Fixed-Base Simulator Training |
Primary outcome
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.
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]
Simulator Sickness
Time frame: Assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. These visits will take place over an average of one week.
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]
Driving Performance
Time frame: Assessed during visit 1, and visit 5. These visits will take place over an average of one week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abiodun Akinwuntan, PhD, MPH MBA principal investigator
University of Kansas School of Health Professions
1 site in 1 country: see every site and its status.
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.