Low-Fidelity PDS for Parkinson's (NCT03969927)
Retrain driving skills using simulator
- Trial ID
- NCT03969927
- 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
- Goal
- Retrain driving skills using simulator
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Kansas Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease, Multiple Sclerosis, Stroke
- Interventions
- Low-Fidelity PDS, High Fidelity Fixed-Base Simulator
Summary For Families
The goal is to help people with stroke, Parkinson's, or multiple sclerosis retrain impaired driving skills so they can drive more safely and confidently. The approach compares a portable, low-fidelity driving simulator with a high-fidelity fixed-base simulator, both of which recreate driving situations so you can practice steering, braking, lane keeping, hazard detection, and reaction timing while getting performance feedback; the portable version is designed to be easier to set up in clinics or homes and the high-fidelity system offers more realistic controls and visuals. Eligible volunteers are adults 25 to 75 with a first-ever stroke, Parkinson's, or MS, a valid driver's license with at least three years' experience, a Mini‑Mental State Exam score of 24 or higher, and binocular vision of at least 20/60; people with traumatic brain injury or other neurological conditions are excluded.
Locations
- Abiodun Akinwuntan, Kansas City, Kansas, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Low-Fidelity PDS. The goal is to help people with stroke, Parkinson's, or multiple sclerosis retrain impaired driving skills so they can drive more safely and confidently. The approach compares a portable, low-fidelity driving simulator with a high-fidelity fixed-base simulator, both of which recreate driving situations so you can practice steering, braking, lane keeping, hazard detection, and reaction timing while getting performance feedback; the portable version is designed to be easier to set up in clinics or homes and the high-fidelity system offers more realistic controls and visuals. Eligible volunteers are adults 25 to 75 with a first-ever stroke, Parkinson's, or MS, a valid driver's license with at least three years' experience, a Mini‑Mental State Exam score of 24 or higher, and binocular vision of at least 20/60; people with traumatic brain injury or other neurological conditions are excluded.
- Who can participate?
- Participants must be between 25 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 10 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Each participant will have a pre-training evaluation, five hours of assigned simulator training divided into five approximately one-hour sessions, and a post-training evaluation; the five training sessions will be completed in two weeks.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.