NCT03969927 · University of Kansas Medical Center
User-friendliness of a Portable Driving Simulator
What this study is about
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).
View original scientific description
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.
Interventions
DEVICE
Low-Fidelity PDS
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.
DEVICE
High Fidelity Fixed-Base Simulator
This intervention uses the large high-fidelity fixed-base driving simulator to retrain study participants and improve their driving related skills.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Kansas City, Kansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 16, 2024 · Source of record for eligibility and locations