Peripheral Neuropathy With Type 2 DiabetesPeripheral Neuropathy Grade 2 or GreaterBalanceBalance Impairment, Gait Disorders, FatigueBalance DisordersPhysical Activities
Investigational drug(s) / intervention(s)
External, lower limb sensory prosthesis
External, lower limb sensory prosthesis: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Activity Score--Metabolic Equivalents (METs) — Over a period of ~12 weeks 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 — Over a period of ~12 weeks 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 — Over a period of ~12 weeks 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) — Baseline, Walkasins Initiation, Follow-up (Week 10) 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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