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

RxFunction

Status: Completed

Conditions: Peripheral Neuropathy; Distorted; Balance; Neuropathy; Sensation Disorders

Treatments: Device: Walkasins OFF; Device: Walkasins ON

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02115633

2R44AG040865-02 (U.S. NIH Grant/Contract)

RxF-NIA-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Walkasins ON then OFF

Experimental group

Description:

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.

Treatment:

Device: Walkasins OFF

Device: Walkasins ON

Walkasins OFF then ON

Experimental group

Description:

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.

Treatment:

Device: Walkasins OFF

Device: Walkasins ON