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

NCT07554443 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Brooks Rehabilitation

    collaborator OTHER

  • RxFunction Inc.

    lead INDUSTRY

Principal Investigators

  • Sutton B Richmond, PhD · RxFunction Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554443 on ClinicalTrials.gov