Walkasins for Peripheral Neuropathy
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.12345
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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use Walkasins or receive fall prevention information for 26 weeks
Control Group Crossover
Control group participants receive Walkasins for the final 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
RxFunction Inc.
Lead Sponsor
Citations
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 ...
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 ...
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.pdfwalk2Wellness
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/fullExtended 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.
Walkasins
Walkasins is a prescribed wearable sensory prosthetic device enabling patients with Sensory Peripheral Neuropathy to improve walking balance and decrease risk ...
Walkasins for Peripheral Neuropathy
Participants used the device for extended periods, and improvements in balance and gait were noted without mention of adverse effects.
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