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

Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Balance; Balance Disorders; Physical Activities; Peripheral Neuropathy Grade 2 or Greater; Peripheral Neuropathy With Type 2 Diabetes; Balance Impairment, Gait Disorders, Fatigue
• Intervention / Treatment: Device: External, lower limb sensory prosthesis

Detailed Description

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
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Grimes; Phone Number: 904-528-3159; Email: Hannah.Grimes@brooksrehab.org
• Study Contact Backup: Name: Dorian Rose, PT, MS, PhD, FAPTA; Phone Number: 352-273-8307; Email: research@rxfunction.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Brooks Rehabilitation Center
      • Contact: Mark B Bowden, PhD; Phone Number: 904.345.6626; Email: research@rxfunction.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Walkasins Users; After the baseline visit and activity monitoring, users will receive Walkasins. They will use the device for 10 weeks during which they will also wear an activPAL activity monitor for ten days on at the beginning and end of their Walkasins use.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, Walkasins Initiation, Follow-up (Week 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-Meter Walk Test	Gait speed will be measured through the 10-Meter Walk Test, timing the middle 10 meters with two meters before and after to allow for acceleration and deceleration. Participants will be instructed to walk at normal speed. Higher numbers indicate faster speeds (i.e., more meters per second).	Baseline, Walkasins Initiation, Follow-up (Week 10)
2-Minute Dual-Task Walk (2MDTW)	The 2-Minute Dual-Task Walk is a measurement of endurance that assesses walking distance over two minutes while also performing a cognitive task (e.g., counting down by 7s from a given number). Greater distances indicate better physical functioning and mobility.	Baseline, Walkasins Initiation, Follow-up (Week 10)
Timed Up and Go (TUG)	The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.	Baseline, Walkasins Initiation,
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)	The Modified Clinical Test of Sensory Interaction in Balance assesses a participant's capacity to sustain balance across four conditions to measure their postural control ability: 1) firm surface eyes open, 2) firm surface eyes closed, 3) foam surface eyes open, and 4) foam surface eyes closed. Participants will stand in each condition for 30 seconds or until they open their eyes in the eyes closed conditions or drop their hands from their hips in the eyes open conditions. Less sway, as measured by sensors, indicates better postural control.	Baseline, Walkasins Initiation, Follow-up (Week 10)
Single Leg Stance (SLS)	The Single Leg Stance Test (also called the unipedal stance test) "is a simple test for measuring static aspects of balance." It "is related to conditions such as peripheral neuropathy and intermittent claudication" and "is also associated with an increased risk for falls" (Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. Journal of geriatric physical therapy. 2007 Apr 1;30(1):8-15). Participants stand unassisted on one leg with their hands on their hips. Timing begins when they lift one leg off the floor and ends when it touches the ground or the standing leg or an arm leaves the hips	Baseline, Walkasins Initiation, Follow-up (Week 10)
Functional Gait Assessment (FGA)	The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability.	Baseline, Walkasins Initiation, Follow-up (Week 10)
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.	Baseline, Walkasins Initiation, Follow-up (Week 10)
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.)	Baseline, Walkasins Initiation, Follow-up (Week 10)
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.	Baseline, Walkasins Initiation, Follow-up (Week 10)
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).	Baseline, Walkasins Initiation, Follow-up (Week 10)
PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance	PROMIS Sleep-Related Impairment assesses the daytime effects of poor or insufficient sleep, such as sleepiness, fatigue, difficulty concentrating, and reduced ability to perform daily activities, also over the past 7 days. Together, these complementary measures capture both sleep quality and the functional impact of sleep problems from the patient's perspective. PROMIS Sleep Disturbance measures perceived problems with sleep itself, including difficulty falling or staying asleep, restlessness, and overall sleep quality over the past 7 days. It reflects the individual's experience during the sleep period. Both are 8-item assessments with higher scores indicating more sleep dysfunction.	Baseline, Walkasins Initiation, Follow-up (Week 10)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: RxFunction Inc.
• Collaborators: Brooks Rehabilitation
• Investigators: Study Director: Sutton B Richmond, PhD, RxFunction Inc.

Publications and helpful links

General Publications

• Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.
• Oddsson LIE, Bisson T, Cohen HS, Jacobs L, Khoshnoodi M, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial. Front Aging Neurosci. 2020 Nov 9;12:592751. doi: 10.3389/fnagi.2020.592751. eCollection 2020.

Helpful Links

• RxFunction, Inc., is the manufacturer of the device used in this study. This link provides more information about Walkasins.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Peripheral Neuropathy; Balance Disorders; Walkasins
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Fatigue; Peripheral Nervous System Diseases; Mobility Limitation; Motor Activity
• Other Study ID Numbers: CIP 0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The sponsor will make a determination on data sharing prior to publication of the results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes