18 Participants NeededMy employer runs this trial

Wearable Sensory Prosthesis for Peripheral Neuropathy

DR
HG
Overseen ByHannah Grimes
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: RxFunction Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Walkasins to determine if it can help people with peripheral neuropathy (nerve damage causing numbness in the feet) walk better and become more active. The study examines whether the device can improve daily movement and balance. Suitable candidates for this trial are individuals over 60 diagnosed with peripheral neuropathy who experience balance difficulties. Participants must wear the Walkasins device daily for ten weeks and complete various walking and balance tests.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance mobility and quality of life for those with peripheral neuropathy.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this neuroprosthesis device is safe for use in individuals with peripheral neuropathy?

Research has shown that Walkasins, a wearable device for people with nerve damage in their feet, is generally safe. In studies, participants used Walkasins without experiencing serious side effects. However, nerve damage can reduce sensation in the feet, so users should carefully avoid skin injuries. Regular skin care and checks are important while using the device. Overall, Walkasins is well-tolerated and aims to improve balance and walking.12345

Why are researchers excited about this trial?

Walkasins is unique because it offers a novel approach to managing peripheral neuropathy by using a wearable sensory prosthesis. Unlike conventional treatments that focus on medication to manage symptoms, Walkasins directly targets balance and mobility issues by providing real-time sensory feedback to users. This innovative device is designed to improve walking stability, potentially reducing the risk of falls and enhancing the quality of life for those affected. Researchers are excited about Walkasins because it represents a shift from pharmacological interventions to a more integrative and user-driven solution, which could lead to significant improvements in daily function for patients with peripheral neuropathy.

What evidence suggests that the Walkasins device is effective for peripheral neuropathy?

Research shows that Walkasins, a wearable device, can help people with peripheral neuropathy improve their balance and walking. In this trial, participants will use Walkasins for 10 weeks. One study found that after using Walkasins, participants felt more confident in their balance, with confidence scores increasing from 33% to 80%. Another study suggests that long-term use of Walkasins not only improves walking and balance but also helps reduce falls. Clinical evidence supports Walkasins' effectiveness in achieving these improvements, making it a promising option for those with peripheral neuropathy. Early results indicate that these benefits last over time, offering hope for lasting improvement.34678

Who Is on the Research Team?

SB

Sutton B Richmond, PhD

Principal Investigator

RxFunction Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have peripheral neuropathy with reduced feeling in their feet and trouble balancing. Participants must be able to walk on their own for at least six minutes (with breaks if needed) and be willing to use the Walkasins device and complete study activities.

Inclusion Criteria

* Be willing to participate in all aspects of physical activity monitoring and study assessments
I am 60 years old or older.
I have PN and have lost feeling in the soles of my feet.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Participants undergo a battery of instrumented mobility assessments, questionnaires, and a 10-day habitual physical activity observation period.

2 weeks
3 visits (in-person)

Treatment

Participants wear Walkasins for 10 weeks as part of their daily routine and are monitored with an activPAL activity monitor.

10 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical activity and balance.

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Walkasins

Trial Overview

The study tests a wearable sensory prosthesis called Walkasins, which includes an insole and ankle strap that provide sensory feedback. The goal is to see if wearing this device daily for ten weeks improves walking, balance, and physical activity in people with nerve damage.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Walkasins UsersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RxFunction Inc.

Lead Sponsor

Trials
3
Recruited
110+

Brooks Rehabilitation

Collaborator

Trials
16
Recruited
1,900+

Citations

Long-Term Use of a Sensory Prosthesis Improves Function in ...

Outcomes: Following Walkasins® use, his Activities-specific Balance Confidence Scale (ABC) scores improved from 33 to 80%. His mean Vestibular Activities of ...

NCT06959277 | Balance4Mobility: Effects of Walkasins ...

The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better.

The Effects of a Wearable Sensory Prosthesis on Gait ... - PMC

The walk2Wellness trial investigates effects of long-term, home-based daily use of a wearable sensory prosthesis on gait function, balance, quality of life and ...

walk2Wellness study results published in Frontiers ...

The walk2Wellness study suggests that long-term use of Walkasins, a wearable lower limb sensory prosthesis, improves clinical outcomes and may ...

Neuromodulation to improve gait and balance function using a ...

The current study investigated short-term effects of using Walkasins, an external lower-limb sensory neuroprosthesis, on clinical outcomes of balance and gait.

Clinical Research | Walkasins by RxFunction

Walkasins is clinically proven to improve balance and gait, and reduce the risk of falls in patients with peripheral neuropathy.

Safety Information

Reduced sensation in the feet from peripheral neuropathy places you at a higher risk for skin injury. Careful attention to proper skin care with Walkasins use ...

Walkasins is a prescribed wearable sensory prosthetic ...

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