Actively Recruiting
Led by RxFunction Inc. · Updated on 2026-04-16
200
Participants Needed
6
Research Sites
30 weeks
Total Duration
Researchers are evaluating the effects of Walkasins, a wearable sensory prosthesis, on balance and gait in people aged 55 and older with peripheral neuropathy and related balance problems. This randomized controlled trial aims to determine if daily use of Walkasins over six months improves users' awareness of foot placement and reduces fall risk compared to a control group. The study focuses on a Medicare-representative population to support potential insurance coverage. Participants are randomly assigned to either the Walkasins user group or a control group. The user group wears the Walkasins device, which includes a Haptic Module and Receptor Sole for each leg, for one year and receives fall prevention education. The control group receives fall prevention information initially and then uses Walkasins during the last six months of the study. The device provides tactile cues based on foot pressure to aid balance and walking. Throughout the study, participants will complete various walking and balance tests at multiple time points up to one year, including the Functional Gait Assessment and 10-Meter Walk Test. They will also report on their physical activity, pain, and device experience. Researchers will monitor falls and collect safety data. Study visits and phone calls will support tracking progress and adherence.
CONDITIONS
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants randomized to the Walkasins user group will use the Walkasins device daily for one year (52 weeks) while also receiving fall prevention education. Participants randomized to the control group will receive fall prevention education initially and start using Walkasins after six months for the remaining six months of the trial.
Multiple visits for assessments at Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
Total: 6 locations
1
OrthoArizona--Mesa Arbor Avenue
Mesa, Arizona, United States, 85206
Active, Not Recruiting
2
Marcus Institute for Aging Research, Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
Active, Not Recruiting
3
Fairview Frontiers
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
4
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
5
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Actively Recruiting
6
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
C
Clinical Research Project Manager
L
Lars Oddsson, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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