Clinical trial NCT02115633: A Wearable "Balance Booster" - Stepping Closer to the Market
Official title: A Wearable "Balance Booster" - Stepping Closer to the Market
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distorted; Balance
Sensation Disorders
Peripheral Neuropathy
Neuropathy
Lead sponsor: RxFunction Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-04-16
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Functional Gait Assessment (FGA)
timeFrame: During one test session < 3 hours
Secondary outcomes:
measure: Four-Stage Balance Test >30s
timeFrame: The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.
measure: 10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed
timeFrame: During one test session < 3 hours
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Measure was administered only at baseline during one test session <3 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Minneapolis VA
name: Sara Koehler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.