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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorRxFunction Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Walkasins
  • Fall Prevention Training

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators