Walkasins for Peripheral Neuropathy

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Walkasins for Peripheral Neuropathy?

Research shows that Walkasins, a wearable device, helps improve balance and walking in people with peripheral neuropathy by providing sensory cues to replace lost foot sensation. Studies found that users experienced better gait and balance scores, increased walking speed, and reduced fall risk after using Walkasins. ^{1 2 3 4 5}

Is Walkasins safe for use in humans?

The studies on Walkasins, a device used to help with balance and gait in people with peripheral neuropathy, do not report any safety concerns. Participants used the device for extended periods, and improvements in balance and gait were noted without mention of adverse effects. ^{1 2 3 5 6}

How does the Walkasins treatment differ from other treatments for peripheral neuropathy?

Walkasins is unique because it is a wearable device that provides sensory balance cues through a shoe insert and leg unit, helping to improve gait and balance by substituting lost nerve function with tactile information, unlike traditional treatments that may focus on medication or physical therapy. ^{1 2 3 7 8}

Research Team

Lars Oddsson, PhD

Principal Investigator

RxFunction Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - A randomized control cross-over study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Use of a Sensory Prosthesis Improves Function in a Patient With Peripheral Neuropathy: A Case Report. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Interventions improve gait regularity in patients with peripheral neuropathy while walking on an irregular surface under low light. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Validity of the chemotherapy-induced peripheral neuropathy self-check sheet. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Falls and gait characteristics among older persons with peripheral neuropathy. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Quality improvement in neurology: Distal symmetric polyneuropathy quality measures. [2021]