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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-28

Brief Summary

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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.

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Detailed Description

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Our specific aims are to:

1. Revise and finalize design of Walkasins® based on accomplishments, user input, as well as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for clinical testing.

Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2. This goal is accomplished.
2. Investigate effects of using Walkasins on clinical outcomes related to gait, balance function and associated fall risk in a population of patients with sensory peripheral neuropathy and balance problems.

Hypotheses 1A-B: Patients who are trained to use Walkasins programmed to display relevant balance cues will attain higher gait speed and Functional Gait Assessment when compared to a matched cohort not using Walkasins.

Milestone 2: Data collection to assess clinical utility and safety of the Walkasins on patients briefly trained to use the device has been completed.

Conditions

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Distorted; Balance Sensation Disorders Peripheral Neuropathy Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Walkasins ON then OFF

Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a 1 hour rest period they will be retested with Walkasins turned off.

Group Type EXPERIMENTAL

Walkasins ON

Intervention Type DEVICE

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

Walkasins OFF

Intervention Type DEVICE

Subjects will be wearing a device that is turned off.

Walkasins OFF then ON

Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a 1 hour rest period they will be retested with Walkasins turned on.

Group Type EXPERIMENTAL

Walkasins ON

Intervention Type DEVICE

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

Walkasins OFF

Intervention Type DEVICE

Subjects will be wearing a device that is turned off.

Interventions

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Walkasins ON

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

Intervention Type DEVICE

Walkasins OFF

Subjects will be wearing a device that is turned off.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients of any age diagnosed with Peripheral Neuropathy and who experience balance problems.
* Ability to perceive the Walkasins vibration feedback, understand and physically act on the vibration feedback.

Exclusion Criteria

* Vibration to the skin is contraindicated by physician

* Use of ankle foot orthotic that prevents attachment of Walkasins device
* Foot size smaller than Woman's 5 or larger than Men's 13

Eligible Sex

ALL

Accepts Healthy Volunteers

No