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

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ClinicalTrials.gov Identifier: NCT02115633
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
RxFunction Inc.

Brief 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 NIA 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.

Condition or disease Intervention/treatment Phase
Distorted; Balance Sensation Disorders Peripheral Neuropathy Neuropathy Device: Walkasins ON Device: Walkasins OFF Phase 2

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  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Wearable "Balance Booster" - Stepping Closer to the Market
Study Start Date : May 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017

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.




Primary Outcome Measures :
  1. Functional Gait Assessment [ Time Frame: During one test session < 3 hours ]
    10 item scale used to assess FGA, standard procedure used in PT


Secondary Outcome Measures :
  1. Gait Speed [ Time Frame: During one test session < 3 hours ]
    10m Walk test used to assess Gait Speed, normal and fast

  2. ABC Balance confidence scale [ Time Frame: During one test session < 3 hours ]
    Measure to assess balance confidence in this population



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115633


Sponsors and Collaborators
RxFunction Inc.
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sara Koehler, PhD Minneapolis VA

Responsible Party: RxFunction Inc.
ClinicalTrials.gov Identifier: NCT02115633     History of Changes
Other Study ID Numbers: RxF-NIA-001
2R44AG040865-02 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Sensation Disorders
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms