Actively Recruiting
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Led by RxFunction Inc. · Updated on 2026-04-16
200
Participants Needed
6
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Ability to stand on one leg for at least 30 seconds
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
C
Clinical Research Project Manager
CONTACT
L
Lars Oddsson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here