NUSHU shoe for Parkinson's (NCT06975059)
Vibrating shoe improves walking stability
- Trial ID
- NCT06975059
- Official Title
- Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
- Goal
- Vibrating shoe improves walking stability
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Weill Medical College of Cornell University
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- NUSHU shoe
Summary For Families
The goal is to map how gait and balance change across early, moderate, and advanced Parkinson's, and to test whether vibrotactile foot cues from the NUSHU shoe can improve stability and step timing. The approach uses a sensor-packed, wearable shoe that records steps, sway, and asymmetry while delivering timed vibrations to the foot to provide rhythmic cues that may help with balance and gait, it is noninvasive and designed to be used alongside usual medications like levodopa rather than replace them. Eligible participants are adults 18 and older with a PD diagnosis who can walk independently and score 22 or higher on the MoCA, and the study also enrolls healthy adults 18 and older with no neurological disease; people who cannot wear the device or have other major brain or gait disorders are excluded.
Locations
- Weill Cornell, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying NUSHU shoe. The goal is to map how gait and balance change across early, moderate, and advanced Parkinson's, and to test whether vibrotactile foot cues from the NUSHU shoe can improve stability and step timing. The approach uses a sensor-packed, wearable shoe that records steps, sway, and asymmetry while delivering timed vibrations to the foot to provide rhythmic cues that may help with balance and gait, it is noninvasive and designed to be used alongside usual medications like levodopa rather than replace them. Eligible participants are adults 18 and older with a PD diagnosis who can walk independently and score 22 or higher on the MoCA, and the study also enrolls healthy adults 18 and older with no neurological disease; people who cannot wear the device or have other major brain or gait disorders are excluded.
- Who can participate?
- Participants must be at least 18 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 2 years and 1 month.
- 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?
- Participants have four in-person visits, and at three of those visits they will wear the shoes with and without vibration in clinic.