Frailty is a common clinical condition in which older adults are at high risk for falls, disability, hospitalization, and death. Approximately, 10% of adults 65 years or older are frail and 42% are prefrail with high risk of progressing to frailty. Current screening for frailty hinges on infrequent o?ce visits and a patient's report of symptoms, which often fail to detect subtle decline. Impaired physical function is a major indicator of frailty. However, clinical evaluations do not adequately re?ect daily life functional performance. In Phase I, we demonstrated the feasibility of our HOME system to continuously measure functional mobility for 7 days in older people. We have shown that HOME measures are more sensitive than gait in the clinic to indicate physical health status and future falls. In this Phase II, we aim to determine if HOME can better identify geriatric health (frailty) as well as fall risk. We will prepare HOME for a commercial launch as the ?rst continuous monitoring system to help clinicians and clinical researchers identify frailty status and fall risk and determine the e?cacy of interventions on actual functional performance in real life. Our speci?c aims are:
AIM I. Clinical Research: Demonstrate the clinical utility of HOME in identifying frailty status and fall risk.
AIM II. Technology Development: Prepare HOME for clinical practice and FDA 510(k) clearance to clinical market. We will develop an instrumented, lightweight ankle wrap (SmartSox) with inertial sensors for continuous gait and turning monitoring, expand our Mobility Exchange clinical data management system to facilitate access to mobility data and generate clinical reports, and complete the HOME validation and veri?cation.
The objective of this Phase II project is to develop and commercialize a wearable system, called HOME, for continuous monitoring of mobility. At the completion of this Phase II grant, we will have the ?rst commercial system that can measure mobility, characterize turning and gait over a week of continuous monitoring in older adults at risk of frailty and falls. We will also have the ?rst wirelessly synchronized ankle wrap instrumented with inertial sensors to monitor spontaneous turning and gait. HOME will be suitable for use in medical applications and research to assess mobility, frailty, fall risk, and response to interventions.