Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals With Peripheral Neuropathy and Balance Problems - A Randomized Control Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
OrthoArizona--Mesa Arbor Avenue
NOT_YET_RECRUITING
Mesa
Massachusetts
Marcus Institute for Aging Research, Hebrew SeniorLife
RECRUITING
Boston
Minnesota
Fairview Frontiers
RECRUITING
Saint Paul
New York
Dent Neurologic Institute
RECRUITING
Amherst
Texas
University of Texas Medical Branch
RECRUITING
Galveston
Contact Information
Primary
Clinical Research Project Manager
research@rxfunction.com
612-358-2141
Backup
Lars Oddsson, PhD
research@rxfunction.com
888-382-3518
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Walkasins User Group
Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.
Other: Control Group
Participants randomized to the control group will receive fall prevention information during the baseline visit. After six months, they will receive Walkasins for use during the final six months of the trial.
Sponsors
Leads: RxFunction Inc.

This content was sourced from clinicaltrials.gov