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Portable Driving Simulator for Neurological Conditions
N/A
Recruiting
Led By Abiodun Akinwuntan, PhD, MPH MBA
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of a first ever stroke, PD, or MS
Be older than 18 years old
Must not have
Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. these visits will take place over an average of one week.
Awards & highlights
No Placebo-Only Group
Summary
This trialwill explore the efficacy of a low-cost, low-fidelity, portable driving simulator to retrain driving skills of stroke survivors, Parkinson's and MS patients.
Who is the study for?
This trial is for individuals with a first-ever stroke, Parkinson's disease (PD), or multiple sclerosis (MS) who have valid driver's licenses and at least 3 years of driving experience. They must score ≥24 on the Mini-mental State Examination and have binocular acuity meeting Kansas driving laws.
What is being tested?
The study compares a low-cost portable driving simulator (PDS) to a high-fidelity fixed-base simulator in retraining driving skills. Participants will be randomly assigned to one of these tools for training and evaluated before and after the sessions.
What are the potential side effects?
Potential side effects may include simulator sickness, which is less expected with the PDS due to its simpler setup compared to the high-fidelity simulator.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with stroke, Parkinson's disease, or multiple sclerosis for the first time.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a brain injury or another neurological condition, but not stroke, Parkinson's, or MS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. these visits will take place over an average of one week.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. these visits will take place over an average of one week.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Driving Performance
Simulator Sickness
User-Friendliness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-Fidelity PDS TrainingExperimental Treatment1 Intervention
Individuals with stroke, PD, or MS
Group II: High Fidelity Fixed-Base Simulator TrainingActive Control1 Intervention
Individuals with stroke, PD, or MS
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
515 Previous Clinical Trials
177,124 Total Patients Enrolled
8 Trials studying Stroke
653 Patients Enrolled for Stroke
Abiodun Akinwuntan, PhD, MPH MBAPrincipal InvestigatorUniversity of Kansas School of Health Professions