Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity

N/ANot Yet RecruitingNCT07554443

RxFunction Inc.18 enrolled

Overview

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.

This will be a prospective within-participant study design conducted over a period of one year. After providing informed consent, all participants will undergo a battery of instrumented mobility assessments (e.g., 6-minute walk test \[6MWT\], Functional Gait Assessment \[FGA\], etc.), questionnaires, and a 10-day habitual physical activity observation period, wearing an electronic event logger to derive the primary outcomes. This initial (baseline) assessment, without the sensory assistance of the Walkasins, will allow participants to serve as their own control. Assessment and observation periods will be repeated at the dispensing of the Walkasins device and after participants have acclimated to daily use, 10 weeks after participants have begun wearing the device.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Interventions

External, lower limb sensory prosthesisDEVICE

Walkasins 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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) * Be willing to use the Walkasins device as recommended * Be willing to participate in all aspects of physical activity monitoring and study assessments Exclusion Criteria: * 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 * 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 * Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \<23 seconds

Outcomes

Primary Outcomes

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.

Time frame: Over a period of ~12 weeks

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.

Time frame: Over a period of ~12 weeks

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.

Time frame: Over a period of ~12 weeks

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.