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Wearable gadget aims to stop falls in neuropathy patients

NCT ID NCT06959277

Symptom relief Sponsor: RxFunction Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 4 times

Summary

This study tests a device called Walkasins, worn on the lower legs, that vibrates to give sensory feedback about foot pressure. The goal is to see if using it daily for six months improves balance and walking in 200 adults aged 55+ with peripheral neuropathy. Participants will do walking tests and report their fall experiences, comparing results to a control group that gets the device later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Walkasins (a lower limb sensory prosthesis device)
What this could lead to
If it works, this device could help people with peripheral neuropathy feel more stable and reduce their risk of falling during daily activities.
What could go wrong
This is a relatively small trial (200 people) and the device is not a treatment for the underlying nerve damage. It may not work for everyone, and long-term benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to understand and provide informed consent for him or herself * Age 55 and older, male or female * Able to complete all functional outcome measures without the use of an assistive device * Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-chemotherapy, indicating that their PN has become a chronic condition. * Self-reported gait and balance problems * Foot size that allows the Walkasins to function appropriately * Willing to use the Walkasins device as recommended Exclusion Criteria: * Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he/she is excluded because his/her balance is likely not impaired enough to benefit from Walkasins.) * Self-reported acute thrombophlebitis, including deep vein thrombosis * Self-reported severe peripheral vascular disease * Untreated lymphedema * Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use * Self-reported, untreated fractures in the foot and ankle * Other neurological or musculoskeletal conditions that moderately or severely impact walking * Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins * Weight of more than 300 pounds * Inability to perceive vibration from Walkasins Haptic Module

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced neuropathy diabetic neuropathy Mobility Limitation peripheral nervous system disorder peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Balance control in elderly Gait disorders Peripheral neuropathies Peripheral neuropathy due to chemotherapy Peripheral neuropathy with type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dent Neurologic Institute

    RECRUITING

    Amherst, New York, 14226, United States

  • Fairview Frontiers

    ACTIVE_NOT_RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • Marcus Institute for Aging Research, Hebrew SeniorLife

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02131, United States

  • OrthoArizona--Mesa Arbor Avenue

    ACTIVE_NOT_RECRUITING

    Mesa, Arizona, 85206, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15206, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

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