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

Description

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

Peripheral NeuropathiesPeripheral Neuropathy Due to ChemotherapyPeripheral Neuropathy With Type 2 DiabetesBalance Control in ElderlyGait Disorders
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Related Conditions:

Peripheral NeuropathiesPeripheral Neuropathy Due to ChemotherapyPeripheral Neuropathy With Type 2 DiabetesBalance Control in ElderlyGait Disorders

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Peripheral Neuropathies
Intervention / Treatment

-

Contacts and Locations

Boston

Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, United States, 02131

St. Paul

Fairview Frontiers, St. Paul, Minnesota, United States, 55102

Amherst

Dent Neurologic Institute, Amherst, New York, United States, 14226

Galveston

University of Texas Medical Branch, Galveston, Texas, United States, 77555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

RxFunction Inc.,

Lars Oddsson, PhD, STUDY_DIRECTOR, RxFunction Inc.

Study Record Dates

2027-12-31