The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy.
Participants will do the following as part of the study:
* Complete a sensation and balance assessment to determine eligibility for the study. * Answer questions about their medical history, physical function, balance confidence, and sleep. * Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker. * Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed. * Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.
Be 60 years of age or older
Have a diagnosis of PN with plantar sensory loss
Demonstrate balance impairment, defined as a Single-Leg Stance time of <23 seconds
Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
Under 60 years old
Do not have a diagnosis of PN with plantar sensory loss
Self-reported acute thrombophlebitis, including deep vein thrombosis
Self-reported severe peripheral vascular disease
Single group
External, lower limb sensory prosthesis
DeviceWalkasins is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.
Activity Score--Metabolic Equivalents (METs)
The Activity Score, expressed in metabolic equivalents (METs), reflects the overall intensity of physical activity performed. (One MET is defined as the energy a person uses when resting or sitting still.) Higher MET values indicate greater energy expenditure and higher levels of physical activity, while lower values suggest reduced activity intensity and increased sedentary behavior.
Step Count
Step count reflects the total number of steps accumulated over a given period and serves as an indicator of overall daily ambulatory activity. Lower step counts are associated with reduced physical activity levels and decreased functional mobility.
Total Sedentary Time
Total sedentary time reflects the individual's overall inactivity during the day. Prolonged sedentary behavior may contribute to deconditioning, decreased functional capacity, and increased risk for chronic disease.
6-Minute Walk Test--Phase Coordination Index (PCI)
The 6 Minute Walk Test is an exercise test used to evaluate aerobic capacity and endurance. The distance a subject walks in six minutes is the outcome by which to compare changes in performance capacity. Participants will wear sensors during the test that will allow for calculation of Phase Coordination Index (PCI) scores. A PCI score closer to zero indicates better bilateral coordination or better phase generation accuracy and/or consistency within the gait cycle.
Activities-specific Balance Confidence (ABC) Scale
The ABC Scale is a 16-item self-report measure of an individual's confidence in their ability to maintain balance while performing various daily activities. Scores range from 0% to 100% to reflect perceived balance confidence, with lower scores indicating greater fear of falling and increased risk of mobility limitations.
International Physical Activity Questionnaire (IPAQ) or IPAQ for Elderly Adults (IPAQ-E)
The International Physical Activity Questionnaire (IPAQ short form) can be used to obtain comparable estimates of physical activity between populations and countries. It consists of four questions that ask participants to state how much time they have spent engaged in various activities over the past 7 days. A higher score on the International Physical Activity Questionnaire (IPAQ) is better. The IPAQ measures physical activity in MET-minutes/week, where higher scores indicate greater physical activity, categorizing individuals as low, moderate, or high (3000+ MET-min/week) in terms of activity levels. (A MET \[Metabolic Equivalent of Task\] is a unit used to measure the energy expenditure and intensity of physical activities relative to resting, defined as the oxygen consumption of 3.5 mL/kg/min.)
PROMIS Scale v2.0 - Pain Intensity 3a
The PROMIS® Pain Intensity assessment was developed to capture the overall level of pain experienced by the individual, independent of its cause or location, allowing comparisons across patient groups and over time. It consists of three questions, rated on a scale from "No pain" to "Very severe" with higher scores indicative of greater pain intensity.
PROMIS PROWalk
PROMIS® PROWalk is a patient-reported outcome measure assessing perceived walking-related functional limitations. It captures individuals' subjective experiences of mobility challenges with lower scores indicating greater physical function impairment. Participants rate their physical function on nine tasks, using a scale of 1 (Unable to do) to 5 (Without any difficulty).
Monofilament Testing
The Centers for Medicare \& Medicaid Services (CMS) identifies the monofilament test as the means of diagnosing loss of protective sensation (https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=171). To conduct the test, a clinician applies pressure with various sizes of monofilament to selected parts of the foot and asks the participant to indicate when he/she feels the filament. Per CMS, inability to feel a 10-gram monofilament on at least two of five test sites on either foot indicates loss of protective sensation (LOPS). For this study participants will undergo testing on at four sites on the dominant foot with a 2g and/or 10g monofilament.
Click on the lead sponsor to view all of their trials.
RxFunction Inc.
Lead sponsor
Brooks Rehabilitation
Collaborator
