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

Launched by RXFUNCTION INC. · Apr 28, 2025

Keywords

ClinConnect Summary

The Balance4Mobility clinical trial is studying whether a device called Walkasins can help people with balance problems caused by conditions like peripheral neuropathy, especially those related to chemotherapy or diabetes. The main goal is to see if using Walkasins daily for six months can help participants feel more aware of where their feet are when they walk, which may improve their balance. Researchers will compare those using Walkasins to a group that does not use the device, and after six months, everyone in the study will have the chance to use Walkasins.

To participate in this trial, individuals need to be 55 years or older and have a diagnosis of peripheral neuropathy, along with some reported balance issues. Participants will need to complete some walking and standing tests, answer questions about their health, and wear the Walkasins device regularly. They will also keep track of any falls and report them to the study team. This trial is not yet recruiting, so it’s a good opportunity for those who are looking for ways to improve their balance and mobility.

Gender

ALL

Eligibility 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