Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

Last updated: July 15, 2025
Sponsor: RxFunction Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Fall Prevention Training

Walkasins

Clinical Study ID

NCT06959277
CIP 0010
  • Ages > 55
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and provide informed consent for him or herself

  • Age 55 and older, male or female

  • Able to complete all functional outcome measures without the use of an assistivedevice

  • Clinical diagnosis of peripheral neuropathy prior to participating in the study asdocumented in the participant's medical record or by physician's note. Individualswith chemo-induced peripheral neuropathy must be at least one-yearpost-chemotherapy, indicating that their PN has become a chronic condition.

  • Self-reported gait and balance problems

  • Foot size that allows the Walkasins to function appropriately

  • Willing to use the Walkasins device as recommended

Exclusion

Exclusion Criteria:

  • Ability to stand on one leg for at least 30 seconds (If the person can stand for atleast 30 seconds, he/she is excluded because his/her balance is likely not impairedenough to benefit from Walkasins.)

  • 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 oreruptions 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 impactwalking

  • 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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Fall Prevention Training
Phase:
Study Start date:
June 17, 2025
Estimated Completion Date:
December 31, 2027

Study Description

A randomized cross-over study of short-term, in-clinic effects of Walkasins use, conducted at the Minneapolis Veterans Affairs Medical Center (VAMC) and published in PLOS ONE, found clinically meaningful and statistically significant improvements in gait speed and functional balance in patients with SPN using Walkasins. The authors stated that "findings suggest new sensory balance cues provided to the lower limb can modulate the activity of relevant nerve afferents and become integrated into sensorimotor control of balance and gait."

In 2020 a multi-site clinical trial of the long-term effects of daily Walkasins use (walk2Wellness, ClinicalTrials.gov #NCT03538756) was published in Frontiers in Aging Neuroscience. After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which is associated with a lower fall risk. The authors concluded that "a wearable sensory prosthesis may provide a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN."

Most recently, an analysis of data from 26 weeks of Walkasins use in the walk2Wellness trial showed that "participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study as compared to self-report 6-month pre-study (11.8 vs. 6.7 falls/1000 patient days, respectively, p <0.004), similar to the 46% decrease reported after 10 weeks of use."

The present study involves an assessment of Walkasins through a randomized, controlled trial with a primary endpoint of 26 weeks. Furthermore, this study will enroll only individuals 55 and older with a goal of including participants that reflect the Medicare population to support payer reimbursement for Walkasins.

The objectives of this study are as follows:

  • Reflect real-world use of Walkasins in a Medicare-representative population who have sensory peripheral neuropathy and associated gait and balance problems and who would be eligible for a prescription to use the device.

  • Investigate the impact of Walkasins use on relevant clinical outcomes associated with gait and physical function.

  • Demonstrate based on patient reporting that Walkasins improves awareness of foot placement on the ground indicating partial replacement of plantar mechanoreceptor function, lost due to peripheral neuropathy.

  • Investigate whether plantar monofilament testing at levels <10g (5.07, LOPS) are associated with gait and balance issues. Is there a Loss Of Balance Sensation (LOBS) threshold that is <10g? The monofilament test protocol should include plantar sites across the foot since differences in anteroposterior and/or mediolateral sensitivity may cause balance issues.

  • Compare the rate of injurious falls between a group of Walkasins users and non-users over a six-month period.

Connect with a study center

  • Marcus Institute for Aging Research, Hebrew SeniorLife

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Fairview Frontiers

    St. Paul, Minnesota 55102
    United States

    Active - Recruiting

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Active - Recruiting

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

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