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Smart sock aims to steady shaky steps in nerve damage patients

NCT ID NCT07554443

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called Walkasins, worn like an ankle strap and insole, that gives gentle vibrations to help people with peripheral neuropathy feel their feet better. The goal is to see if it improves walking, balance, and daily physical activity. Eighteen adults aged 60 and older with nerve damage will wear the device for 10 weeks while researchers track their steps, activity levels, and walking tests.

What this could mean

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

Active substance
Walkasins wearable sensory prosthesis
What this could lead to
If it works, this device could help older adults with nerve damage walk better, feel steadier, and be more active in daily life.
What could go wrong
This is a small early study with only 18 people, so results may not apply to everyone. The device may not improve activity or balance for all users.

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 18 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

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

60 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: * Be 60 years of age or older * Have a diagnosis of PN with plantar sensory loss * Demonstrate balance impairment, defined as a Single-Leg Stance time of \<23 seconds * Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted) * Be willing to use the Walkasins device as recommended * Be willing to participate in all aspects of physical activity monitoring and study assessments Exclusion Criteria: * Under 60 years old * Do not have a diagnosis of PN with plantar sensory loss * 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 * Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \<23 seconds

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy Fatigue Mobility Limitation Motor Activity peripheral nervous system disorder peripheral neuropathy

As listed by the trial registrant

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

Balance Balance disorders Balance impairment, gait disorders, fatigue Peripheral neuropathy grade 2 or greater Peripheral neuropathy with type 2 diabetes Physical activities

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

    1 site. 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

  • Brooks Rehabilitation Center

    RECRUITING

    Jacksonville, Florida, 32216, United States

    Contact Email: •••••@•••••

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