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

October 4, 2018 updated by: RxFunction Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Gait Assessment (FGA)
Time Frame: During one test session < 3 hours
The Functional Gait Assessment (FGA) is a reliable and valid measure of gait function related to postural stability and has been shown to be effective in classifying fall risk in older adults and predicting unexplained falls in community-dwelling older adults (Wrisley, Marchetti et al. 2004; Wrisley and Kumar 2010). It has also been validated in stroke survivors (Lin, Hsu et al. 2010) and patients with Parkinson's disease (Leddy, Crowner et al. 2011) and has less flooring and ceiling effect than the Dynamic Gait Index (Lin, Hsu et al. 2010). The FGA includes a 10-item scale; each item is scored from 0 to 3 (3=normal, 2=mild impairment, 1=moderate impairment, 0=severe impairment). The maximum score is 30; minimum score, 0. Higher scores represent a better outcome. To be included in the count of participants, subjects' FGA scores needed to improve more than 4 points, which is the Minimally Clinically Important Difference (MCID) (Beninato et al. 2014).
During one test session < 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Four-Stage Balance Test >30s
Time Frame: The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.
The 4-Stage Balance Test is part of the STEADI protocol recommended by the Centers for Disease Control and Prevention (CDC) to assess fall-risk in elderly individuals. It includes four gradually more challenging postures the subject performs; 1) Stand with feet side by side; 2) Stand with feet in semi-tandem stance; 3) Stand with feet in tandem stance; 4) Stand on one leg. Subjects pass if they can hold the stance for 10 seconds and then move on to the next stance. A fail during tasks 1, 2, or 3 indicates a high risk of falling, i.e., a total performance time of less than 30 seconds.
The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.
10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed
Time Frame: During one test session < 3 hours
The 10m-walk is routinely done in rehabilitation and has excellent reliability in chronic stroke patients. In addition, gait speed has been found to be an important predictor of survival in older adults (Hardy, Perera et al. 2006), further emphasizing its importance as a clinical outcomes measure. Gait speed (10-meter walk, timing only the middle 6 meters to allow for acceleration and deceleration) was assessed by instructing subjects to walk at their normal speed. A difference of 0.10m/sec is defined as the Minimally Clinical Important Difference (MCID) (Perera, Mody et al. 2006). Lower scores (# of seconds) on this measure indicate a better outcome. To be included in the count of participants, subjects' times on the 10M Walk Test needed to improve by more than 0.10m/sec, the MCID.
During one test session < 3 hours
Activities-Specific Balance Confidence Scale (ABC)
Time Frame: Measure was administered only at baseline during one test session <3 hours.
Powell and Myers (1995) developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in elderly persons. The ABC scale is a one-page questionnaire that asks questions about balance confidence when performing 16 different tasks. The items are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (16). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance. The ABC Scale was assessed only at baseline to document the level of balance confidence the subjects had before beginning the study intervention.
Measure was administered only at baseline during one test session <3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RxFunction Inc.

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Sara Koehler, PhD, Minneapolis VA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 28, 2017

Study Completion (Actual)

July 28, 2017

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RxF-NIA-001
  • 2R44AG040865-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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