Walkasins for Peripheral Neuropathy

Recruiting at 5 trial locations

Overseen By Clinical Research Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RxFunction Inc.

Disqualifiers: Thrombophlebitis, Vascular disease, Lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 26 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Walkasins, a wearable device, to determine if it can help individuals with peripheral neuropathy (nerve damage that causes numbness) improve their balance. Researchers aim to discover whether using Walkasins daily for six months enhances users' awareness of foot placement and improves performance on standing and walking tests. Participants will either use the device immediately or after six months in a comparison group. Individuals diagnosed with peripheral neuropathy, who have self-reported gait and balance issues, and are willing to use the device may be well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding how Walkasins can enhance daily life for those with peripheral neuropathy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study staff or your doctor.

What prior data suggests that the Walkasins device is safe for people with peripheral neuropathy?

Research has shown that Walkasins, a wearable device for individuals with nerve damage in their feet, is generally safe. In studies where participants used Walkasins over extended periods, they experienced improved balance and walking. Importantly, no negative side effects were reported, indicating that users tolerate the device well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Walkasins is unique because it offers a non-invasive, wearable solution for managing peripheral neuropathy. Unlike traditional treatments that often involve medications or physical therapy, Walkasins uses haptic feedback technology to help users regain balance and prevent falls. This device consists of a Haptic Module and a Receptor Sole, which work together to provide sensory cues directly to the feet, enhancing stability. Researchers are excited about Walkasins because it empowers individuals to improve their mobility and safety through an innovative approach, potentially reducing reliance on drugs and improving quality of life.

What evidence suggests that the Walkasins device is effective for improving balance in people with peripheral neuropathy?

Studies have shown that Walkasins can help people with peripheral neuropathy improve their balance and walking. After using Walkasins for 10 weeks, users demonstrated significant improvements in walking ability and speed, allowing them to walk better and more confidently. Research indicates that daily use of Walkasins can lower the risk of falls over time. The device provides feedback to enhance users' awareness of foot placement, which is crucial for maintaining balance. Overall, evidence suggests that Walkasins can effectively improve balance and reduce fall risk for those with peripheral neuropathy. Participants in this trial will be randomized into two groups: the Walkasins User Group, who will use the device for one year, and the Control Group, who will receive fall prevention information initially and then use Walkasins during the final six months of the trial. ^{1 2 4 6 7}

Who Is on the Research Team?

Lars Oddsson, PhD

Principal Investigator

RxFunction Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with peripheral neuropathy, which often causes balance problems and abnormal gait. Ideal candidates have not found relief through standard treatments and are willing to try a new device called Walkasins alongside fall prevention training. Participants must be able to attend study visits, perform walking tests, answer medical questions, and report any falls.

Inclusion Criteria

I can perform daily activities without help from devices.

My foot size is compatible with Walkasins.

Willing to use the Walkasins device as recommended

Exclusion Criteria

I have had a blood clot in my vein recently.

I have untreated fractures in my foot or ankle that I reported myself.

Inability to perceive vibration from Walkasins Haptic Module

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use Walkasins or receive fall prevention information for 26 weeks

26 weeks

Regular in-person visits and phone calls

Control Group Crossover

Control group participants receive Walkasins for the final 26 weeks

26 weeks

Regular in-person visits and phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Walkasins

Trial Overview The trial is testing the effectiveness of Walkasins—a wearable device designed to improve foot placement awareness—over six months. Researchers will compare the balance and walking test results of those using Walkasins daily with a control group who will receive the device after the study period.

How Is the Trial Designed?

Group I: Walkasins User Group Experimental Treatment 2 Interventions

Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.

Group II: Control Group Experimental Treatment 1 Intervention

Participants randomized to the control group will receive fall prevention information during the baseline visit. After six months, they will receive Walkasins for use during the final six months of the trial.

Who Is Running the Clinical Trial?

RxFunction Inc.

Lead Sponsor

Trials

3

Recruited

110+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7680959/

The Effects of a Wearable Sensory Prosthesis on Gait and ... Sensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of long-term, home ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06959277

Balance4Mobility: Effects of Walkasins Use in Individuals ... After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which ...

3. trialx.com trialx.com/clinical-trials/listings/323143/balance4mobility-effects-of-walkasins-use-in-individuals-with-peripheral-neuropathy-and-balance-problems/

Effects of Walkasins Use in Individuals With Peripheral ... After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which ...

4. rxfunction.com rxfunction.com/wp-content/uploads/2020/02/AP-10046v2_walk2Wellness_StudyUpdate_FEB2020.pdf

walk2Wellness Patients using Walkasins every day, who receive tactile sensory balance information, will improve outcomes of gait function, balance confidence, physical ...

5. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.931048/full

Extended effects of a wearable sensory prosthesis on gait, ... Conclusion: A wearable sensory prosthesis can improve outcomes of gait and balance function and substantially decreases incidence of falls during long-term use.

6. rxfunction.com rxfunction.com/wp-content/uploads/2024/08/Info_Prescibers_AP-10063_v6_0124.pdf

Walkasins Walkasins is a prescribed wearable sensory prosthetic device enabling patients with Sensory Peripheral Neuropathy to improve walking balance and decrease risk ...

7. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-4-2025-8fa49

Walkasins for Peripheral Neuropathy Participants used the device for extended periods, and improvements in balance and gait were noted without mention of adverse effects.