SBIR-STTR Award

The long term objective of this SBIR application is to develop and test a minimum viable product (MVP) of Rock Steady, a software application for adults with vestibular dysfunction. This product is relevant to the mission of the NIDCD because it addresses the request for, “the development of technologies for the study, diagnosis, and treatment of balance disorders, particularly for the elderly”. The envisioned product is an elegantly simple mobile application that is designed to measure adherence to a home exercise program of gaze stability exercises based on recommendations from the 2016 Clinical Practice Guidelines for Vestibular Rehabilitation. This product was conceived in response to four main drivers: 1) the growing number of adults aging with balance impairments due to vestibular dysfunction, 2) the finding that vestibular rehabilitation therapy (VRT) improves quality of life, 3) the need for developing engaging exercise programs that will improve adherence to VRT, and 4) a lack of commercially available low cost tools to support VRT. This application is very timely given the growth in the number of older adults and the ease of dissemination via smart tablets/PCs which are being adopted by older adults at faster rates than ever before. By deploying the app on common digital technology we will ensure its widespread adoption. Finally, it will be designed with end user feedback from all stakeholder groups including people with vestibular dysfunction. Broad Objective: We intend to translate existing evidence-based educational material, assessments and gaze stability exercises to a mobile device for widespread dissemination and adoption to increase adherence with home and clinic based VRT, promote health and wellbeing and improve patient care and outcomes through coordinated higher quality of care. Approach: In Phase 1 we will 1) employ user-centered design methodologies to develop and evaluate reliability, validity and usability of Rock Steady 1.0 for adults with vestibular dysfunction, over age 60, 2) integrate eye/head tracking and 3) identify and evaluate feature and content expansions/adaptations for Rock Steady 2.0. In Phase 2 we will employ user-centered, iterative design approaches to develop Rock Steady 2.0 and further feasibility, usability, and a pilot effectiveness study. Research Design: We will use a randomized trial design to evaluate reliability, validity and usability. All participants will complete two versions of standard evaluations of vestibular dysfunction using traditional paper/pencil method and via the app. Participants will be randomized to begin with either the app or traditional approaches. Reliability will be compared using interclass correlation coefficient, validity will be evaluated using Pearson/Spearman statistics and usability will be evaluated using the System Usability Scale questionnaire. Expected Outcomes: We believe that Rock Steady will be a valid and reliable adjunct to VRT. The app will provide healthcare professionals with important data regarding adherence, and function while also reducing the cost of care delivery.

Public Health Relevance Statement:
Project Narrative This proposal describes the development of Rock Steady, a novel approach to fall risk reduction through digital assessment and guided exercises for adults with balance impairments due to vestibular deficits. Rock Steady presents opportunities for improved management of fall risk and quality of life and to containing the cost of health care in the elderly.

Project Terms:
Address; Adherence; Administrator; Adopted; Adoption; Adult; Age; Aging; Arts; base; Benchmarking; Boredom; care delivery; Clinic; Clinical Practice Guideline; Computer software; cost; Data; design; Development; Diagnosis; digital; Disease; Dizziness; document outlines; Educational Materials; Effectiveness; Elderly; Ensure; equilibration disorder; Equilibrium; Evaluation; evidence base; Exercise; exercise program; expectation; Eye; Fall prevention; fall risk; falls; Feedback; Functional disorder; Funding; Gait; gaze; Goals; Growth; handheld mobile device; Head; Head Movements; Health; Health Care Costs; Health Professional; Home environment; improved; Interview; iterative design; Learning; Lower Extremity; Measures; Mechanics; Methodology; Methods; Mission; mobile application; Motion; National Institute on Deafness and Other Communication Disorders; Needs Assessment; new technology; novel strategies; Outcome; Paper; Participant; Patient Care; Patient-Focused Outcomes; Patients; Peripheral; Phase; Population Study; Production; programs; prototype; Public Health; Quality of Care; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; randomized trial; Recommendation; Recording of previous events; reduce symptoms; Rehabilitation therapy; Reporting; Research; Research Design; Research Personnel; response; Risk; Risk Assessment; Risk Reduction; Scientist; screening; sensor; Small Business Innovation Research Grant; software development; statistics; success; System; Tablets; Technology; Technology Development Study; Testing; TimeLine; tool; Training; Translating; trial design; usability; user centered design; Validity and Reliability; Vertigo; vestibulo-ocular reflex; virtual reality; Vision

The long-term objective of this SBIR application is to develop and test Rock Steady, a software application for older adults with dizziness. This product is relevant to the mission of the NIDCD because it addresses the request for, “the development of technologies for the study, diagnosis, and treatment of balance disorders, particularly for the elderly”. The envisioned product is an elegantly simple mobile application that is designed to evaluate impairment, track symptoms, and measure adherence to gaze stability home exercise programs which are based on recommendations from the 2016 Clinical Practice Guidelines for Vestibular Rehabilitation. Rock Steady was conceived in response to four main limitations in the current VRT healthcare delivery model: 1) access, 2) the need for developing engaging exercise programs that will improve adherence to VRT, 3) poor performance, and 4) absence of remote monitoring capabilities. This application is very timely given the ever-enlarging older adult population and the ease of dissemination via smart tablets/PCs which are being adopted by older adults at faster rates than ever before. Deploying the app on common digital technology will ensure its widespread adoption. Finally, it will be designed with feedback from all stakeholder groups including people with vestibular dysfunction. The objective of Phase II is to complete the research and development of gamified gaze stability exercises and to conduct an exploratory pilot study to gather data about Rock Steady's ability to address current limitations in the standard VRT delivery model; and to gather data that will inform the design of a future randomized clinical trial (RCT). Phase I Progress: We developed the Rock Steady prototype and evaluated its reliability, validity and usability, integrated eye/head tracking, obtained feedback from stakeholders (clinicians and patients) and identified and evaluated content expansions for Rock Steady. Phase 2 Aims. Specific Aim 1: Complete development of Rock Steady based on results from Phase 1, and Specific Aim 2: Conduct an exploratory pilot study to gather data about Rock Steady's ability to address current limitations in the standard VRT delivery model; and to gather data that will inform the design of a future randomized clinical trial (RCT). Research Design: The pilot will be a randomized pre- test/post-test parallel group trial; participants will receive either A) standard vestibular rehabilitation (S-VRT) or B) digital vestibular rehabilitation using the Rock Steady app (D-VRT) to use at home for 4 weeks. Outcomes will be collected: pre- and post-test sessions. Outcomes: We will use semi-structured interviews, usability surveys, functional outcomes and game/sensor outcomes to evaluate Rock Steady. Expected Outcomes: We believe that Rock Steady will provide appropriate feedback to patients and clinicians, improve adherence, be usable, enable remote monitoring and be feasibly used as part of a home exercise program that positively impacts function in adults with dizziness.

Public Health Relevance Statement:
Project Narrative This proposal describes the development of Rock Steady, a novel approach to fall risk reduction through digital assessment and guided exercises for older adults with balance impairments due to dizziness. Rock Steady offers opportunities for improved management of fall risk, improved quality of life, and health care cost containment in elderly populations.

Project Terms:
Address; Adherence; Adopted; Adoption; Adult; Age; age group; aged; American; Anxiety; attenuation; base; Boredom; Chronic; Clinic; clinical practice; Clinical Practice Guideline; Computer software; Cost Control; Data; design; Development; Diagnosis; digital; Disease; Dizziness; Elderly; Ensure; equilibration disorder; Equilibrium; Exercise; exercise program; expectation; experience; Eye; Eye Movements; fall risk; fear of falling; Feedback; Functional disorder; functional outcomes; Future; gaze; Goals; Head; Head Movements; Health Care Costs; health care delivery; Home environment; Impairment; improved; improved outcome; Individual; innovation; Intervention; Interview; iterative design; Lead; Measures; Medical; Mental Depression; Methods; Mission; mobile application; Modeling; Monitor; National Institute on Deafness and Other Communication Disorders; novel strategies; Outcome; Paper; Participant; Patients; Performance; Phase; Physical Performance; Pilot Projects; Population; Posture; power analysis; Pre-Post Tests; Procedures; programs; prototype; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; reduce symptoms; Rehabilitation Outcome; Rehabilitation therapy; Reporting; Research; research and development; Research Design; response; Risk Reduction; sensor; Service delivery model; Small Business Innovation Research Grant; Speed; standard of care; Structure; Supervision; Surveys; symptom treatment; Symptoms; Tablets; Technology; Technology Development Study; Testing; therapy adherence; Time; tool; usability