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

NCT02115633 | Completed Results FDA Device

• 2 other identifiers: RxF-NIA-0012R44AG040865-02
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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 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

Distorted; Balance; Sensation Disorders; Peripheral Neuropathy; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment (FGA)

  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 Outcomes (3)

• Four-Stage Balance Test >30s

  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

  During one test session < 3 hours

• Activities-Specific Balance Confidence Scale (ABC)

  Measure was administered only at baseline during one test session <3 hours.

Study Arms (2)

Walkasins ON then OFF

EXPERIMENTAL

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; Device: Walkasins OFF

Walkasins OFF then ON

EXPERIMENTAL

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; Device: Walkasins OFF

Interventions

Walkasins ON 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 then ON; Walkasins ON then OFF

Walkasins OFF DEVICE

Subjects will be wearing a device that is turned off.

Walkasins OFF then ON; Walkasins ON then OFF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RxFunction Inc.: lead
• National Institute on Aging (NIA): collaborator

Related Publications (8)

• Beninato M, Fernandes A, Plummer LS. Minimal clinically important difference of the functional gait assessment in older adults. Phys Ther. 2014 Nov;94(11):1594-603. doi: 10.2522/ptj.20130596. Epub 2014 Jun 19.

  PMID: 24947198 BACKGROUND

• Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007 Nov;55(11):1727-34. doi: 10.1111/j.1532-5415.2007.01413.x. Epub 2007 Oct 3.

  PMID: 17916121 BACKGROUND

• Leddy AL, Crowner BE, Earhart GM. Functional gait assessment and balance evaluation system test: reliability, validity, sensitivity, and specificity for identifying individuals with Parkinson disease who fall. Phys Ther. 2011 Jan;91(1):102-13. doi: 10.2522/ptj.20100113. Epub 2010 Nov 11.

  PMID: 21071506 BACKGROUND

• Lin JH, Hsu MJ, Hsu HW, Wu HC, Hsieh CL. Psychometric comparisons of 3 functional ambulation measures for patients with stroke. Stroke. 2010 Sep;41(9):2021-5. doi: 10.1161/STROKEAHA.110.589739. Epub 2010 Jul 29.

  PMID: 20671244 BACKGROUND

• Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.

  PMID: 16696738 BACKGROUND

• Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

  PMID: 7814786 BACKGROUND

• Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.

  PMID: 20360052 BACKGROUND

• Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

  PMID: 15449976 BACKGROUND

MeSH Terms

Conditions

Sensation Disorders; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Limitations and Caveats

Study limitations included the following: * The study was not blinded. * The study involved a small group consisting of males only. * The study was only short-term (\<3 hours).

Results Point of Contact

• Title: Lars Oddsson, PhD
• Organization: RxFunction, Inc.

loddsson@rxfunction.com

8572340382

Study Officials

• Sara Koehler, PhD

  Minneapolis VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2016
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: October 30, 2018
• Results First Posted: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share