User-friendliness of a Portable Driving Simulator
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Aug 2019
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedAugust 16, 2024
August 1, 2024
5.8 years
May 25, 2019
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
User-Friendliness
User-Friendliness will be assessed using a User-Friendliness Survey which is a Likert scale. \[1-5 scale with 1 representing the lowest degree of user-friendliness and 5 representing the highest degree of user-friendliness\]
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. \[This will be reported from a 0-228.14 scale with 0 representing the lowest possible degree of Simulator Sickness and 228.14 indicating the greatest possible degree of Simulator Sickness\]
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.
Assessed during visit 1, and visit 5. These visits will take place over an average of one week.
Study Arms (2)
Low-Fidelity PDS Training
EXPERIMENTALIndividuals with stroke, PD, or MS
High Fidelity Fixed-Base Simulator Training
ACTIVE COMPARATORIndividuals with stroke, PD, or MS
Interventions
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.
This intervention uses the large high-fidelity fixed-base driving simulator to retrain study participants and improve their driving related skills.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abiodun Akinwuntan
Kansas City, Kansas, 66160-8500, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abiodun Akinwuntan, PhD, MPH MBA
University of Kansas School of Health Professions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participant and the research assistant providing the training are not masked. The rest of the study conductors are masked regarding participant arm allocation.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2019
First Posted
May 31, 2019
Study Start
August 28, 2019
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data will be available after the completion of the study.
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.