SBIR-STTR Award

Loss of balance function can lead to falls resulting in injury and even death. Epidemiological evidence has linked peripheral neuropathies to an increased risk of falling and one out of three elderly individuals age 65 and older falls at least once every year. This project will initiate commercialization of a wearable balance prosthetic device that can enhance balance and mobility. The device, termed ""SmartSock"", measures foot pressure in real time and conveys foot pressure information to the subject through a vibrotactile feedback array, placed around the lower leg. The device can either substitute lost foot pressure sensation;e.g. in individuals with peripheral neuropathy or it can act as a ""balance booster"" providing an augmentation of sensory information to individuals with general balance problems. The device can be worn in bed at night and turns on automatically when the wearer gets out of bed to go, e.g. to the bathroom. Using a first generation wearable prototype of the SmartSock we have acquired pilot data demonstrating that clinical parameters reflecting gait balance and mobility improve when elderly at-risk fallers use the device bringing them to non-faller status. Our current in-house hand-made version is not suitable for clinical trials and manufacturing. The current Phase 1 project will produce a next generation prototype of the device that will be tested for comfort and wearability in a small group of at-risk fallers. Our specific aims are to: 1. Design a new insole concept as two blanks (""small"" and ""large"") that can be injection molded to incorporate air-pressure bladders, can be used to cut out intermediate sole sizes overall covering size feet between Mondopoint 225 to 295 (US women's size 5 to US men's size 12) and is integrated with pressure sensor electronics. 2. Select an optimal microcontroller and implement power-saving modes (standby/sleep) in the current software to better utilize features to extend battery life of the device. 3. Test the new device on elderly individuals (five men and five women) to ensure it provides relevant pressure feedback, is comfortable and is easy to don and doff. Achieving these aims will provide a robust new prototype of the SmartSock technology designed for use in a clinical setting. This would represent an important and critical step in the commercialization process of this technology, and enable clinical trials in a future Phase 2 proposal.

Public Health Relevance:
Loss of balance function can lead to falls resulting in injury and even death. This project will initiate commercialization of a wearable balance prosthetic device that can enhance balance and mobility. The device, termed ""SmartSock"", measures foot pressure in real time and conveys foot pressure information to the subject through a vibrotactile feedback array, placed around the lower leg. The device can either substitute lost foot pressure sensation, e.g. in individuals with peripheral neuropathy, or it can act as a ""balance booster"" providing an augmentation of sensory information to individuals with general balance problems.

Thesaurus Terms:
Age;Aged 65 And Over;Air Pressure;Beds;Bladder;Bladder Urinary System;Cessation Of Life;Clinical;Clinical Trials;Computer Software;Data;Death;Devices;Elderly;Electronics;Ensure;Epidemiology;Equilibrium;Esthesia;Feedback;Filamentous Fungi;Future;Gait;Generations;Goals;Health Care Costs;Health Costs;Healthcare Costs;Hospitals;Housing;Individual;Injection Of Therapeutic Agent;Injections;Injury;Lead;Leg;Life;Link;Location;Measures;Molds;Pns Diseases;Patients;Pb Element;Peripheral Nerve Diseases;Peripheral Nervous System Diseases;Peripheral Nervous System Disorders;Peripheral Neuropathy;Phase;Process;Prosthesis;Prosthetic Device;Prosthetics;Qol;Quality Of Life;Risk;Safety;Sensation;Sensory;Sleep;Societies;Software;Technology;Testing;Time;Training;Woman;Advanced Age;Balance;Balance Function;Balance Prosthesis;Balance Prosthetic;Base;Clinical Investigation;Commercialization;Computer Program/Software;Design;Designing;Elders;Epidemiologic;Epidemiological;Fall Risk;Falls;Foot;Geriatric;Heavy Metal Pb;Heavy Metal Lead;Improved;Improving Mobility;Indexing;Late Life;Later Life;Men;Men's;Next Generation;Older Adult;Older Person;Over 65 Elderly;Pressure;Prototype;Senior Citizen;Sensor;Urinary Bladder

The overall goal of this project is to continue development and commercialization of a Balance Sensory Augmentation and Substitution System (B-SASS). The device termed Walkasins" measures foot pressure through a thin sole insert, developed under recent 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 either substitute lost foot pressure sensation; e.g. in individuals with peripheral neuropathy or it can act as a "balance booster" providing an augmentation of sensory information to individuals with general balance problems. The device can be worn in bed at night and turns on automatically when the wearer gets out of bed to go, e.g. to the bathroom. We have acquired pilot data demonstrating that clinical parameters reflecting gait balance and mobility improve when elderly at-risk fallers use the device bringing them to non- faller status. For the current Phase II proposal 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 2. In a double-blind randomized control trial investigate effects of using Walkasins" on clinical outcomes related to gait, balance functio and associated fall risk in a hospital-based outpatient rehabilitation program at the Sister Kenny Rehabilitation Institute in Minneapolis. Hypotheses 1A-C: Patients who participate in a comprehensive outpatient rehabilitation program and use Walkasins" programmed to display relevant balance cues will attain higher gait speed, Functional Gait Assessment and Balance Confidence following their episode of care when compared to a matched cohort using Walkasins" programmed to vibrate similarly although unrelated to balance. Hypothesis 2: Patients who use Walkasins" on a daily basis during their episode of care will not experience issues related to skin irritation. Milestone 2: Data confirming the clinical utility and long-term se safety of the Walkasins" on patients' participating in a hospital-based comprehensive outpatient rehabilitation program.

Public Health Relevance:
Loss of balance function can lead to falls resulting in injury and even death. This project will continue development and commercialization of a wearable balance prosthetic device that can enhance balance and mobility. The device, termed "Walkasins", measures foot pressure in real time and provides foot pressure information to the subject through a vibrotactile feedback array, placed around the lower leg. The device can either substitute lost foot pressure sensation, e.g. in individuals with peripheral neuropathy, or t can act as a "balance booster" providing an augmentation of sensory information to individuals with general balance problems.

Public Health Relevance Statement:
Loss of balance function can lead to falls resulting in injury and even death. This project will continue development and commercialization of a wearable balance prosthetic device that can enhance balance and mobility. The device, termed "Walkasins", measures foot pressure in real time and provides foot pressure information to the subject through a vibrotactile feedback array, placed around the lower leg. The device can either substitute lost foot pressure sensation, e.g. in individuals with peripheral neuropathy, or t can act as a "balance booster" providing an augmentation of sensory information to individuals with general balance problems.

Project Terms:
Address; Algorithms; Attention; balance prosthesis; base; Beds; care episode; Cessation of life; Clinical; cohort; Collaborations; commercialization; Communities; Computer software; cost; Cues; Data; design; Development; Device Designs; Devices; Double-Blind Method; Elderly; Ensure; Environment; Equilibrium; Esthesia; experience; fall risk; falls; Feedback; foot; Funding; Gait; Goals; Grant; Hand; Health Care Costs; Home environment; Hospitals; improved; improving mobility; indexing; Individual; Injury; Institutes; Lead; Leg; Legal patent; Long-Term Effects; Marketing; Measures; men; Microprocessor; Molds; Outcome; Outpatients; Patients; Peripheral Nervous System Diseases; Phase; Preparation; pressure; programs; Prosthesis; prototype; Publications; Quality of life; Randomized Controlled Trials; Rehabilitation therapy; Research; research clinical testing; Research Support; Rest; Risk; Safety; sensor; Sensory; Silicones; Sister; skin irritation; Speed (motion); System; Testing; Textiles; Time; Training; usability; user-friendly; vibration; Walking; Woman