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

Sponsored by RxFunction Inc.

About this study

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.

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 clinicall…

Where this study is enrolling (3)

Who can participate

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 assistive device
  • ✓Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-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 criteria

  • ✕Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he/she is excluded because his/her balance is likely not impaired enough 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 or eruptions 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 impact walking
  • ✕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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.