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

RxFunction Inc. · NCT06959277

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
4
Study start
June 17, 2025
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Walkasins; Fall Prevention Training

Conditions: Peripheral Neuropathies; Peripheral Neuropathy Due to Chemotherapy; Peripheral Neuropathy With Type 2 Diabetes; Balance Control in Elderly; Gait Disorders

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Fairview Frontiers

    Saint Paul, MN 55102

    Site contact: Sarah Zwagerman · 651-232-0101 · Sarah.Zwagerman@fairview.org

  • Dent Neurologic Institute

    Amherst, NY 14226

    Site contact: Clinical Research Coordinator · 716-250-7002 · CBlackwell@dentinstitute.com

  • University of Pittsburgh

    Pittsburgh, PA 15206

    Site contact: Goeran Fiedler, PhD · 412-624-6475 · gfiedler@pitt.edu

  • University of Texas Medical Branch

    Galveston, TX 77555

    Site contact: Gregory Brusola, PhD, DPT, PT · 409-772-0309 · gabrusol@utmb.edu

Study contacts (from the official record)

  • Clinical Research Project Manager · 612-358-2141 · research@rxfunction.com
  • Lars Oddsson, PhD · 612-358-2141 · research@rxfunction.com
All diabetes studies in Minnesota →
Balance4Mobility: Effects of Walkasins Use in Individuals With… (NCT06959277) | Bored Studies