Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-28 @ 9:19 PM
Study NCT ID:
NCT02115633
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Wearable "Balance Booster" - Stepping Closer to the Market
Sponsor:
RxFunction Inc.
Organization:
Study Overview
Official Title:
A Wearable "Balance Booster" - Stepping Closer to the Market
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R44AG040865-02 | NIH | None | https://reporter.nih.gov/quic… | View |