No phaseRecruitingHealthspan endpoint
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
- Sponsor
- RxFunction Inc. (Industry)
- Enrolment
- 200 planned
- Conditions
- Peripheral Neuropathies; Peripheral Neuropathy Due to Chemotherapy; Peripheral Neuropathy With Type 2 Diabetes; Balance Control in Elderly; Gait Disorders
- Interventions
- Walkasins; Fall Prevention Training
- Ages
- adults, older adults
- Registry
- NCT06959277
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Functional Gait Assessment (FGA)
- Patient-Specific Functional Scale (PSFS)
- PROMIS® PROWalk
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered