Trials / Completed
CompletedNCT02115633
A Wearable "Balance Booster" - Stepping Closer to the Market
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- RxFunction Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Walkasins ON | Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway. |
| DEVICE | Walkasins OFF | Subjects will be wearing a device that is turned off. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-07-28
- Completion
- 2017-07-28
- First posted
- 2014-04-16
- Last updated
- 2018-10-30
- Results posted
- 2018-10-30
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02115633. Inclusion in this directory is not an endorsement.