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A Wearable "Balance Booster" - Stepping Closer to the Market

NCT02115633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-10-30

Study results available
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Summary

The overall goal of this project is to continue development and commercialization of a Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a thin sole insert, developed under National Institute on Aging (NIA) Small Business Innovation Research (SBIR) Phase I funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. The device can replace lost foot pressure sensation in individuals with peripheral neuropathy who have balance problems.

Conditions

Interventions

DEVICE

Walkasins ON

Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.

DEVICE

Walkasins OFF

Subjects will be wearing a device that is turned off.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • RxFunction Inc.

    lead INDUSTRY

Principal Investigators

  • Sara Koehler, PhD · Minneapolis VA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-07-28
Completion
2017-07-28
FDA Device
Yes

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Entities

Diseases

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 NCT02115633 on ClinicalTrials.gov