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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether daily use of Walkasins for six months helps people feel where their feet are on the ground and improves balance. It is for adults age 55 and older with peripheral neuropathy (nerve damage) and walking and balance problems. Researchers will compare people using Walkasins with people who will get the device after six months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 55 or older.
  • Be able to understand the study and agree to take part for yourself.
  • Be able to finish all movement tests without a walking aid.
  • Have peripheral neuropathy (nerve damage) confirmed in your medical record or a doctor's note.
  • If chemotherapy caused your nerve damage, have finished chemotherapy at least one year ago.
  • Report problems with walking and balance.
  • Have feet that fit Walkasins so it works properly.
  • Be willing to use Walkasins as recommended.

Who can't join

  • Can stand on one leg for at least 30 seconds.
  • Report a current inflamed vein with a blood clot, including a clot in a deep vein, or severe poor blood flow in your limbs.
  • Have untreated lymphedema (swelling from a buildup of lymph fluid).
  • Have an untreated sore, swelling, infection, inflamed skin, or rash on the lower leg near where the device is worn.
  • Report an untreated broken bone in your foot or ankle.
  • Have another nerve, muscle, bone, or joint condition that affects walking moderately or severely.
  • Use an ankle-foot brace for walking that prevents you from putting on Walkasins.
  • Weigh more than 300 pounds or cannot feel vibrations from Walkasins.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (6)

AZ

MA

MN

NY

PA

TX