N/A
Completed N=31
A Wearable "Balance Booster" - Stepping Closer to the Market
Distorted; Balance · Sensation Disorders · peripheral neuropathy · neuropathy
Source: ClinicalTrials.gov NCT02115633 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Functional Gait Assessment (FGA) — 17; 7 Participants
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.
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 | — |
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
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. Informational only — not medical advice.