APDM, INC. — Department of Health and Human Services SBIR Phase II: NIA

Description

Project Summary Falls are the leading cause of injurieshospital visitsnursing home admissionsand reduced quality of life for people with neurological disordersAlthough there is consensus that impaired mobility is the basis for most fallsit is very di cult to evaluate these complex abilities outside a laboratory settingBrief clinical examinations do not accurately re ect dailyfunctional mobility in real life environmentsPatients at risk of falls would bene t from a system they can easily use to measure their daily mobilityassess mobilityuctuations throughout the dayevaluate their risk of fallingand measure e ects of interventions aimed at improving their functional mobility and reducing their fallsNo commercial technology yet exists to continuously monitoructuations in mobility or quantify fall risk in natural environments during normal activitiesWe developed and validated an unobtrusive systemcalled Mobility Lifeto objectively characterize gait and turning during spontaneous activities with wearable inertial sensorsDuring this Phase IIwe will develop an instrumented ankle wrap for continuous monitoring of gaitdevelop a user interface to support clinical researchdevelop reports that show indications of fall risk for clinical practiceand thoroughly verify and validate our technologyWe will also determine which metrics are most indicative of fall risk and determine normative values for non fallers in the same age range as the expected patient populationsOur speci c aims areAIM ITechnology DevelopmentPrepare Mobility Life for clinical practiceMilestoneDevelop an instrumented elastic ankle bandageSmartSoxfor continuous gait monitoringMilestoneDevelop useful clinical reports to convey patientsandaposdaily mobility impairmentsuctuationsandfall riskMilestoneComplete the system veri cation and validation in preparation for FDAkclearance to marketAim IIClinical ResearchDemonstrate the clinical utility of Mobility Life to monitor quality of functional mobility and fall risk in neurological patientsMilestoneDetermine which daily life mobility impairments best predict fall risk in patients with PD or MSMilestoneDevelop reference values for integrity of functional mobility in healthy age matched subjects Project Narrative The objective of this Phase II project is to develop and commercialize a wearable inertial sensors systemcalled Mobility Lifefor continuous monitoring of mobilityAt the completion of the proposed work for this direct to Phase II grantwe will have therst system that can continuously measure mobilitycharacterize turning and balance during gait across weeks of continuous monitoring of patients in and outside their homeand assess patientsandaposfall riskWe will also have therst wirelessly synchronized ankle wrap instrumented with inertial sensors to monitor gait and foot movementsMobility Life will be suitable for use in medical applications to assess mobilityuctuationsresponse to medicationand disease progression in people with neurological disorders such as Parkinsonandapos s disease PDand multiple sclerosisMS