SBIR-STTR Award

Home: Monitoring Balance and Gait with the Home Objective Mobility Exam
Award last edited on: 6/12/2018

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$2,356,515
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Mahmoud El-Gohary

Company Information

APDM Inc

2828 Southwest Corbett Avenue Suite 130
Portland, OR 97201
   (503) 445-7757
   info@apdm.com
   www.apdm.com
Location: Single
Congr. District: 03
County: Multnomah

Phase I

Contract Number: 1R43AG044863-01
Start Date: 6/1/2013    Completed: 5/31/2015
Phase I year
2013
Phase I Amount
$349,836
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 physicians and 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 movement monitoring. 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 Statement:


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: the world'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, physical therapists, and clinical trialists so they can more quickly improve interventions to prevent or limit mobility disability.

Project Terms:
aging population; base; Biomedical Engineering; Blood Pressure; Cardiac; Characteristics; Charge; Chronic; Clinic; Clinic Visits; Clinical; Clinical assessments; clinical decision-making; Clinical Research; Collection; Computers; Craniocerebral Trauma; Data; Data Analyses; data management; design; Development; developmental disease/disorder; disability; Disease; Disease Progression; Docking; Early Intervention; equilibration disorder; Equilibrium; Exercise; fall risk; falls; Frail Elderly; Funding; Gait; Gait abnormality; gait examination; Goals; Hand; Home environment; Human; improved; innovation; interest; Intervention; Investments; laptop; Leg; Marketing; Measures; Medical; Methods; Monitor; Movement; Movement Disorders; Multiple Sclerosis; multisensory; nervous system disorder; Neurosciences; novel; Parkinson Disease; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physicians; Preparation; prevent; Prevention; public health relevance; Research; Research Personnel; Risk Assessment; Secure; Self Assessment (Psychology); Self-Administered; sensor; stroke; System; Technology; Testing; Time; tool; Training; treatment as usual; Validity and Reliability; Walking; Wireless Technology

Phase II

Contract Number: 5R43AG044863-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2014
(last award dollars: 2018)
Phase II Amount
$2,006,679

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 physicians and 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 improveinterventions 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 movement monitoring. 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 HOMEfor 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.

Thesaurus Terms:
Aging Population;Base;Biomedical Engineering;Blood Pressure;Cardiac;Characteristics;Charge;Chronic;Clinic;Clinic Visits;Clinical;Clinical Assessments;Clinical Decision-Making;Clinical Research;Collection;Computers;Craniocerebral Trauma;Data;Data Analyses;Data Management;Design;Development;Developmental Disease/Disorder;Disability;Disease;Disease Progression;Docking;Early Intervention;Equilibration Disorder;Equilibrium;Exercise;Fall Risk;Falls;Frail Elderly;Funding;Gait;Gait Abnormality;Gait Examination;Goals;Hand;Home Environment;Human;Improved;Innovation;Interest;Intervention;Investments;Laptop;Leg;Marketing;Measures;Medical;Methods;Monitor;Movement;Movement Disorders;Multiple Sclerosis;Multisensory;Nervous System Disorder;Neurosciences;Novel;Parkinson Disease;Patients;Pharmaceutical Preparations;Phase;Physical Therapy;Physicians;Preparation;Prevent;Prevention;Public Health Relevance;Research;Research Personnel;Risk Assessment;Secure;Self Assessment (Psychology);Self-Administered;Sensor;Stroke;System;Technology;Testing;Time;Tool;Training;Treatment As Usual;Validity And Reliability;Walking;Wireless Technology;