Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Recruiting · 6 sites across 6 states
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground. Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study. During the study participants will be asked to do the following: * Answer questions about their medical history and balance. * Do some standing and walking tests. Some of the tests will be timed. * Attend study visits and participate in study phone calls. * Keep track of any falls and notify study staff if they fall. * Wear the Walkasins device on a regular basis.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Age 55 or older (male or female).
- •Has a clinical diagnosis of peripheral neuropathy in their medical record or by a doctor’s note.
- •Reports problems with walking and balance.
- •Foot size that allows the Walkasins to work correctly.
- •Agrees to use the Walkasins device as recommended.
🚫 You may not be able to join if…
- •Cannot stand on one leg for at least 30 seconds (because their balance is likely not impaired enough to benefit).
- •Has acute thrombophlebitis (including deep vein thrombosis) reported by the participant.
- •Has severe peripheral vascular disease reported by the participant.
- •Has untreated swelling/skin problems in the lower leg area where the device would be used (including infection, inflamed skin, eruptions, or swelling/lesions).
- •Cannot perceive vibration from the Walkasins Haptic Module or weighs more than 300 pounds.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 55–any age
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06959277 · Locations: Arizona · Massachusetts · Minnesota · New York · Pennsylvania · Texas