N/A N=31 Randomized Single-blind Treatment

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

Distorted; Balance · Sensation Disorders · Peripheral Neuropathy · Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT02115633 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Functional Gait Assessment (FGA) — 17; 7 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Walkasins ON (Device); Walkasins OFF (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: RxFunction Inc.
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Gait Assessment (FGA)	17; 7	—
SECONDARY Four-Stage Balance Test >30s	27.5; 25.6	—
SECONDARY 10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed	8; 5	—
SECONDARY Activities-Specific Balance Confidence Scale (ABC)	59.6; 64.7	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02115633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.