Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase II | Award Amount: 1.49M | Year: 2014
DESCRIPTION provided by applicant APDM is a young company focused on developing and commercializing professional systems using wearable inertial sensors for monitoring of human movement and movement disorders In Phase I we developed the novel Instrumented Stand and Walk test ISAW using APDMandapos s proprietary Opal movement monitors and Mobility Lab system We validated the ISAW by demonstrating that the ISAW measures were sensitive to severity of Parkinsonandapos s disease PD and levodopa treatment The ISAW allows clinicians and nonexperts to quickly obtain objective measures of standing balance step initiation gait and turning The ultimate goal for the product is to provide a quick portable clinical system to quickly and automatically obtain objective measures of balance and gait disorders to predict fall risk using body worn sensors This Phase II STTR proposal will expand the use of the ISAW from PD to elderly fallers We will partner with the largest longitudinal study of falls in elderl men the Osteoporotic Fractures in Men Study MrOS to characterize balance and gait in community dwelling older men and with the Oregon Center of Aging and Technology ORCATECH in community dwelling older women This proposal will not only demonstrate the feasibility and usefulness of the ISAW to quickly quantify balance and gait for multicenter clinical trials it will also develop a unique Fall Risk Report and provide the ISAW with normative values for the elderly This year study will have both a Clinical Research and a Technology Development Aim to prepare the ISAW to expand market penetration from research to clinical practice as an objective biomarker for fall risk and mobility disability The impact of the ISAW wil be on clinicians interested in measuring fall risk in the elderly including primary care physician neurologists geriatricians rehabilitation professionals assisted living facilities hospitals an athletic trainers The Specific Aims are Aim I Clinical Research Develop a fall risk evaluation system for clinicians from the ISAW test Milestone Develop a Fall Risk Report and Milestone Develop reference values for integrity of balance and gait across older ages Aim II Technology Development Prepare the ISAW to be practical and attractive for clinical practice as well as clinical trials Milestone Mobility Exchange Prepare data repository for multi site clinical data collection from the ISAW test Milestone Mobility Clinic Simplify user interface and reporting for clinicians and Milestone FDA Put quality systems and regulatory compliance in place so ISAW can be marketed for clinical practice This Phase II proposal will transform APDMandapos s ISAW protocol into the first technological system for clinicians Mobility Clinic and clinical researchers Mobility Lab to provide a validated objective fall risk evaluation as well as comprehensive balance and gait disorder assessment PUBLIC HEALTH RELEVANCE The Instrumented Stand and Walk test ISAW uses body worn inertial sensors to provide a quick portable clinical system too quickly and automatically measure balance and gait disorders to predict fall risk This Phase II STTR will characterize balance and gait with the ISAW in community dwelling men and women We will show the usefulness of the ISAW for multicenter clinical trials develop a unique Fall Risk Report collect normative balance and gait values and develop the technology so it is practical and attractive for clinical practice related to fall prevention
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 698.87K | Year: 2013
DESCRIPTION (provided by applicant): Although balance and gait disorders are one of the most common and devastating chronic medical problems of older people, especially those with chronic neurological diseases, clinicians or clinical researchers do not measure balance and gait frequently, accurately, or sensitively. Our long-term goal is to develop and commercialize a unique system called the Home Objective Mobility Exam (HOME) to allow patients to measure their own balance and gait at home. If physiciansand physical therapists could obtain frequent, accurate, self-administered measures of balance and gait characteristics, then they will be able to earlier predict fall risk and changes in mobility. This will also enable them to quickly improve interventions in order to prevent mobility disability. The objective of this application is to deveop a novel method to allow patients to quantify their own standing balance, gait and turning with a quick, simple, and extremely easy to use system. The specifc aims are: Aim I. To develop a new version of the Opal movement monitor for home use. The objective of this aim is to transform the Opal sensors from a computer-based clinician/researcher-controlled system to a nonprofessional/patient-controlled system of movementmonitoring. Aim II. To determine the feasibility, validity and reliability of having people with Parkinson's disease test their own balance and gait at home. We hypothesize that balance and gait, measured by patients in their homes, will be valid and reliable compared with measures administered by research assistants and with clinical scales and show very good test-retest reliability. We will initially develop HOME for patients with Parkinson's disease because they have more falls than any other neurological disorder, but we are confident that this tool will be useful for patients any form of mobility disability, such as multiple sclerosis, stroke, head injury, developmental disorders, multisensory deficits, frail elderly, etc. Based on results of this proposal, our Phase II application will thentest the ability of the HOME to more quickly detect changes in balance and gait following a change in medication or physical therapy, compared to usual care, in preparation for FDA approval and widespread marketing.PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This project allows APDM to determine the feasibility of developing a self-administered balance and gait test for patients with mobility disability, using the core technology of our company: theworld's most advanced body-worn inertial sensors, Opals. This novel, Home Objective Mobility Exam (HOME) will uniquely provide information about day-to-day variability, daily fluctuations, and ecological effects on gait and balance to physicians, physicaltherapists, and clinical trialists so they can more quickly improve interventions to prevent or limit mobility disability.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 662.89K | Year: 2015
DESCRIPTION provided by applicant Cerebral Palsy CP is the most common motor disorder in children affecting more than in every children in the United States Impaired gait is one of the most debilitating effects of CP The current standard for measuring movement impairment in the outpatient clinic involves use of instruments that cannot quantify movement accurately and may be administered differently depending on the userandapos s expertise Instrumented gait analysis IGA is the most common quantitative method used for clinical gait assessment The technique is laboratory based and most commonly uses optical motion capture to characterize the kinematics of motion These systems are the industry gold standard but they are costly cumbersome may suffer from optical occlusion and because they require a dedicated motion laboratory with specialists to collect process and interpret movement data are not easily integrated into the outpatient clinic Thus there is a need for a portable easy to use system to provide objective measurements of gait that are critical for rehabilitation therapy and surgical planning for children with functional limitations associated with CP and other movement disorders The objective of this project is to develop and determine the feasibility of a wearable system called IMove to easily and accurately characterize and assess gait in children with CP IMove will use patented wearable inertial sensors developed and commercialized by our company APDM The system will provide joint kinematics and temporal spatial measures of gait similar to those obtained by optical motion capture systems Furthermore IMove will be portable unobtrusive easy to use and requires no lengthy setup or calibration all of which makes the proposed system well suited for use in the clinic to improve cliniciansandapos decision making around diagnosis prognosis and treatment monitoring We hypothesize that it is feasible to use IMove to measure normal and abnormal gait metrics that are clinically important for CP These metrics include kinematic measurements of pelvic hip knee and ankle joint angles during gait IMove will also provide temporal spatial measures of asymmetry of swing duration due to leg muscle spasticity and variability of step length and duration The long term impact of this technology will be better clinical decisions that are more accessible to the disabled population than current methods of gait analysis This will result in improved diagnosis therapeutic interventions individualized rehabilitation strategies referrals for alternative interventions and sensitive clinical trial outcome measures that can be performed in most outpatient clinics rather than specialized laboratory settings This Phase I project will demonstrate the validity and clinical feasibility of IMove which will justify the investment necessary to develop and commercialize IMove in Phase II This project has two specific aims AIM I Develop IMove to detect the stance and swing phase of gait cycles and to characterize pelvic hip knee and ankle joint angles during these phases The algorithm will utilize wirelessly synchronized inertial sensors attached to the pelvis femur tibia and foot to continuously quantify the joint angles characterize their coordination during the critical temporal events of te gait cycle Milestone Develop a recursive Bayesian tracking algorithm to measure the joint angles of the lower limb during gait using wearable inertial sensors AIM II Validate measures obtained from IMove with those obtained from a motion capture system We hypothesize that IMove will accurately detect stance and swing phases and track the pelvic hip knee and ankle joint angles during gait Milestone To test this hypothesis we will compare the IMove metrics with those obtained from a motion capture system in children with CP and age matched typically developing children PUBLIC HEALTH RELEVANCE This project aims to evaluate the feasibility of developing a clinic friendly system called IMove to assess gait in children with Cerebral Palsy CP IMove will use unobtrusive wearable inertial sensors and novel algorithms to quantify patientsandapos pelvic hip knee and ankle joint angles during gait IMove will also provide temporal spatial measures of asymmetry of swing duration due to leg muscle spasticity and variability of step length and duration This will result in improved diagnosis therapeutic interventions individualized rehabilitation strategies referrals for alternative interventions and sensitive clinical trial oucome measures that can be performed in most outpatient clinics rather than specialized laboratory settings
Agency: Department of Defense | Branch: Air Force | Program: SBIR | Phase: Phase I | Award Amount: 149.80K | Year: 2014
ABSTRACT: Interest in tracking human movement has been motivated by the wide array of its applications in health care, military training, sports, and entertainment. Currently, there is no single motion capture technology that is perfect for every possible use. The most common method of tracking movement is based on optical motion analysis systems. However, these systems are costly, not portable, and suffer from occlusion. Mechanical sensors can be cumbersome, hard to use, and are limited to orientation measurements. Magnetic motion capture systems provide accurate orientation and position, but have limited range, low sampling rates, and their use has to be restricted to areas where magnetic disturbances can be eliminated. Although inertial measurement units (IMUs) can overcome most of the limitations associated with other motion capture systems, orientation and position tracking relying on IMUs alone suffer from integration drifts over long periods of operation, making it difficult or impossible to track the absolute position of body movements. The objective of this project is to develop a new system that combines range and inertial sensors. The new system will utilize novel algorithms to fuse the range and inertial data to track human movement of individuals performing normal daily activities in natural environments. BENEFIT: Combined with the inertial data, range information that directly measures range between pairs of transceivers and our novel tracking algorithms, this new system will continuously estimate absolute and relative body segment positions and orientations with unprecedented precision during long-term monitoring.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 298.61K | Year: 2016
Project Summary Mobility limitations including gait and balance impairments are common in older adults and are a major cause of falls and reduced quality of life Although laboratory studies show that biofeedback during exercise training can improve motor performance physical therapists do not have access to an overground gait biofeedback system for their patients We will develop Mobility Rehab a visual biofeedback system for personalized rehabilitation in which therapists can characterize gait determine which gait condition to train and select the speci c metric to target for training overground or on a treadmill The system will provide reports that show clinically actionable measures of gait and balance This year project has two speci c aims AIM I Develop and validate a visual biofeedback system This aim will be achieved with two milestones Milestone Develop and validate real time algorithms to calculate clinically actionable gait metrics including double support time step time asymmetry foot clearance arm swing pitch angle at heel strike and trunk lateral stability during gait We will validate the new algorithms with a gold standard Motion Analysis system in older adults with gait impairments Milestone Develop a user interface for Mobility Rehab to display real time and longitudinal gait metrics for therapists and their patients AIM II Demonstrate the feasibility of Mobility Rehab for gait training in older adults This aim will be achieved with two milestones Milestone Evaluate the immediate e ects of Mobility Rehab on gait training in adults with gait impairments Milestone Evaluate the clinical usability of Mobility Rehab in a physical therapy practice Project Narrative We will use this Phase I grant to develop Mobility Rehab a exible biofeedback system to provide visual biofeedback for gait training overground or on a treadmill for older adults develop reports that show clinically actionable measures of gait and balance and thoroughly verify and validate our technology
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.81M | Year: 2016
Project Summary Falls are the leading cause of injuries hospital visits nursing home admissions and reduced quality of life for people with neurological disorders Although there is consensus that impaired mobility is the basis for most falls it is very di cult to evaluate these complex abilities outside a laboratory setting Brief clinical examinations do not accurately re ect daily functional mobility in real life environments Patients at risk of falls would bene t from a system they can easily use to measure their daily mobility assess mobility uctuations throughout the day evaluate their risk of falling and measure e ects of interventions aimed at improving their functional mobility and reducing their falls No commercial technology yet exists to continuously monitor uctuations in mobility or quantify fall risk in natural environments during normal activities We developed and validated an unobtrusive system called Mobility Life to objectively characterize gait and turning during spontaneous activities with wearable inertial sensors During this Phase II we will develop an instrumented ankle wrap for continuous monitoring of gait develop a user interface to support clinical research develop reports that show indications of fall risk for clinical practice and thoroughly verify and validate our technology We 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 populations Our speci c aims are AIM I Technology Development Prepare Mobility Life for clinical practice Milestone Develop an instrumented elastic ankle bandage SmartSox for continuous gait monitoring Milestone Develop useful clinical reports to convey patientsandapos daily mobility impairments uctuations and fall risk Milestone Complete the system veri cation and validation in preparation for FDA k clearance to market Aim II Clinical Research Demonstrate the clinical utility of Mobility Life to monitor quality of functional mobility and fall risk in neurological patients Milestone Determine which daily life mobility impairments best predict fall risk in patients with PD or MS Milestone Develop 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 system called Mobility Life for continuous monitoring of mobility At the completion of the proposed work for this direct to Phase II grant we will have the rst system that can continuously measure mobility characterize turning and balance during gait across weeks of continuous monitoring of patients in and outside their home and assess patientsandapos fall risk We will also have the rst wirelessly synchronized ankle wrap instrumented with inertial sensors to monitor gait and foot movements Mobility Life will be suitable for use in medical applications to assess mobility uctuations response to medication and disease progression in people with neurological disorders such as Parkinsonandapos s disease PD and multiple sclerosis MS
Agency: Department of Defense | Branch: Air Force | Program: SBIR | Phase: Phase II | Award Amount: 749.56K | Year: 2016
ABSTRACT:Analysis of human movement with motion capture systems is used in many applications in the domains of health care, military training and simulation, sports, and entertainment. The requirements of these applications have driven the development of new motion capture technologies to improve accuracy, automation, portability, and cost. There is no single motion capture technology that is well suited to all applications. Optical motion capture systems are extremely accurate, but are costly, time-consuming, sensitive to occlusions, non-portable, and are limited to indoor spaces. Magnetic motion capture systems provide accurate orientation and position, but have limited range, low sample rates, and are sensitive to magnetic field disturbances. Inertial motion capture systems can overcome some of these limitations, but cannot provide absolute position and are sensitive to magnetic field disturbances. In Phase I, we demonstrated the feasibility of an innovative approach that fuses ranging sensors with our inertial monitors to continuously estimate orientation and position. Our primary objective of this Phase II project is to use this technology to develop a complete motion capture system that can be used to track human full-body kinematics in a wide variety of research applications that are not well suited to other motion capture technologies.BENEFIT:The commercial Ruby system will be ready for research and development applications requiring biomechanics analysis. This will include both civilian and military applications for which current motion capture technologies are poorly suited due to their limitations. Ruby motion capture will be especially valuable in clinical and military research that requires portability, automation, or accuracy in environments with magnetic field disturbances.
Apdm, Inc. | Date: 2014-11-22
Disclosed embodiments include a multi-function wearable apparatus comprising (a) a sensor module including a plurality of low power solid state kinematics sensors,(b) a microprocessor module comprising a low power microcontroller configured for device control, device status, and device communication; (c) a data storage module comprising a solid state local storage medium, said data storage module configured for sampling and storage of kinematics data; (d) a wireless communication module comprising a low power bidirectional transceiver wherein said wireless communication module is configured for communicating and synchronizing sampling time instances of said sensor module with signals from a second apparatus; and (e) a power module comprising a battery and an energy charging regulator. According to one embodiment, the wearable apparatus is a watch capable of quantifying human movement.
Apdm, Inc. | Date: 2013-06-17
Disclosed embodiments relate to methods, apparatuses, and systems for characterizing gait. Specifically, disclosed embodiments are related methods, apparatuses, and systems for characterizing gait with wearable and wirelessly synchronized inertial measurement units. These include a method for gait characterization that comprises (a) detecting zero-velocity periods using two or more wearable and wirelessly synchronized movement monitoring devices including a triaxial accelerometer and a triaxial gyroscope and (b) calculating temporal measures of gait during walking by estimating the change in position and orientation during each step.
Apdm, Inc. | Date: 2014-01-02
Disclosed embodiments include an apparatus that comprises (a) a kinematics sensor module including an accelerometer, a gyroscope, a magnetometer, or combinations thereof; and (b) a bidirectional wireless communication module configured for wirelessly synchronizing the sampling time instances of the kinematics sensor module with the sampling time instances of at least a second wearable apparatus including a second kinematics sensor module.