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

NCT07554443 | Not Yet Recruiting FDA Device

• 1 other identifier: CIP 0012
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Balance; Balance Impairment, Gait Disorders, Fatigue; Peripheral Neuropathy With Type 2 Diabetes; Peripheral Neuropathy Grade 2 or Greater; Balance Disorders; Physical Activities

Keywords

Peripheral Neuropathy; Walkasins; Balance Disorders; Physical Activity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Activities-specific Balance Confidence (ABC) Scale

  Baseline, Walkasins Initiation, Follow-up (Week 10)

• International Physical Activity Questionnaire (IPAQ) or IPAQ for Elderly Adults (IPAQ-E)

  Baseline, Walkasins Initiation, Follow-up (Week 10)

• PROMIS Scale v2.0 - Pain Intensity 3a

  Baseline, Walkasins Initiation, Follow-up (Week 10)

• PROMIS PROWalk

  Baseline, Walkasins Initiation, Follow-up (Week 10)

• PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance

  Baseline, Walkasins Initiation, Follow-up (Week 10)

Other Outcomes (1)

• Monofilament Testing

  Baseline

Study Arms (1)

Walkasins Users

EXPERIMENTAL

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

Interventions

External, lower limb sensory prosthesis DEVICE

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.

Walkasins Users

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RxFunction Inc.: lead
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation Center

Jacksonville, Florida, 32216, United States

Location

Related Publications (2)

• 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.

  PMID: 36204554 BACKGROUND

• 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.

  PMID: 33240077 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Mobility Limitation; Fatigue; Motor Activity; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sutton B Richmond, PhD

  RxFunction Inc.

  STUDY DIRECTOR

Central Study Contacts

Dorian Rose, PT, MS, PhD, FAPTA

CONTACT

352-273-8307; research@rxfunction.com

Hannah Grimes

CONTACT

904-528-3159; Hannah.Grimes@brooksrehab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)