RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-17
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06959277

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to understand and provide informed consent for him or herself
  2. * Age 55 and older, male or female
  3. * Able to complete all functional outcome measures without the use of an assistive device
  4. * 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.
  5. * Self-reported gait and balance problems
  6. * Foot size that allows the Walkasins to function appropriately
  7. * Willing to use the Walkasins device as recommended
  1. * 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.)
  2. * Self-reported acute thrombophlebitis, including deep vein thrombosis
  3. * Self-reported severe peripheral vascular disease
  4. * Untreated lymphedema
  5. * Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
  6. * Self-reported, untreated fractures in the foot and ankle
  7. * Other neurological or musculoskeletal conditions that moderately or severely impact walking
  8. * Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
  9. * Weight of more than 300 pounds
  10. * Inability to perceive vibration from Walkasins Haptic Module

Contacts and Locations

Study Contact

Clinical Research Project Manager
CONTACT
612-358-2141
research@rxfunction.com
Lars Oddsson, PhD
CONTACT
888-382-3518
research@rxfunction.com

Principal Investigator

Lars Oddsson, PhD
STUDY_DIRECTOR
RxFunction Inc.

Study Locations (Sites)

Marcus Institute for Aging Research, Hebrew SeniorLife
Boston, Massachusetts, 02131
United States
Fairview Frontiers
St. Paul, Minnesota, 55102
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: RxFunction Inc.

  • Lars Oddsson, PhD, STUDY_DIRECTOR, RxFunction Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Walkasins
  • Peripheral Neuropathy
  • Balance Problems

Additional Relevant MeSH Terms

  • Peripheral Neuropathies
  • Peripheral Neuropathy Due to Chemotherapy
  • Peripheral Neuropathy With Type 2 Diabetes
  • Balance Control in Elderly
  • Gait Disorders