SBIR-STTR Award

Traumatic brain injury (TBI) from falls is a major public health problem among older adults in the United States with a substantial impact on the health-care delivery system. Much of the research agenda is focused on medical assessment and exercise programs. Severe disability and death from TBI are relatively high in older adults and particularly in i) frail older adults with impaired balance but continued engagement in independent lifestyles, ii) demented individuals with poor awareness of impaired balance, iii) older adults with pre-existing TBI, iv) delirious, agitated older adults who have a twenty fold increased risk of falling while in a hospital or v) older adults with impaired balance and on anticoagulation medications. Liability from serious head injuries from falls is significant for hospitals and long-term care facilities. Because of a shift to restraint-free environments, there is a need for a practical cranio-protective headgear, and current devices are not adequate. With the aging of the population together with the impact of chronic diseases including dementia and impaired balance and mobility; proven and cost-effective prevention interventions are needed for individuals and available as part of preventive strategies targeted for high risk individuals in acute and long-term care. This proposed study will use validated impact testing methods to compare the effectiveness of different materials and combinations of materials to assess impact attenuation, durability of repeated impacts, and thickness that will relate to design shape and comfort. From these data, three prototype headwear devices will be constructed and analyzed for attenuation of impact data collected on fall simulations using freefall drop tests of an instrumented Hybrid III mannequin that will be analyzed with LifeModTM software to measure peak resultant head deceleration and standardized Head Injury Criteria (HIC) values for unprotected vs. protected conditions of the three prototypes. Results from this proposed study will be used to apply for a Phase II project for end user (both older adults and clinical staff) clinical testing and plans for commercialization including the implementation of start up strategies for manufacturing, distribution and sales.

Public Health Relevance:
Fall-related traumatic brain injury is a major public health problem with substantial impact on healthcare systems that will increase as the population ages. There is a need for more practical, soft, cranio-protective headwear for targeted high risk older adults and clinical settings. This proposal will use standardized methods of impact testing of unique composites to develop prototypes of protective headwear for pre-clinical trial analysis of impact attenuation using simulated falls of instrumented Hybrid-III mannequins using LifeModTM software.

Public Health Relevance:
Fall-related traumatic brain injury is a major public health problem with substantial impact on healthcare systems that will increase as the population ages. There is a need for more practical, soft, cranio-protective headwear for targeted high risk older adults and clinical settings. This proposal will use standardized methods of impact testing of unique composites to develop prototypes of protective headwear for pre-clinical trial analysis of impact attenuation using simulated falls of instrumented Hybrid-III mannequins using LifeModTM software.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

The Centers for Disease Control (CDC) has identified falls-related traumatic brain injury (TBI) in older adults as a significant and unrecognized public health issue;with 8000 deaths from falls- related TBI in older adults and 56,000 hospitalizations, at a mean cost of $16,006/$19,191 for women/men >64 years reported in 2005;prompting a public service campaign4. The challenges of maintaining independence in mobility and physiologic conditioning for wellness while avoiding injury due to impaired balance can contribute to the downward spiraling to frailty and loss of independence. The very deficits associated with many chronic conditions with aging that lead to mobility and balance difficulties, often contribute to cognitive changes that limit the effectiveness of rehabilitation and safety training and overall awareness of self-limitations15. Some of the increase incidence in and mortality from TBI is associated with anticoagulation therapy, including aspirin and the 2 million new users of warfarin each year12. To address this challenge, with the support of NIH Phase I SBIR funds, a new lightweight, un-obtrusive medical headgear with over 90% impact force reduction using was developed using advanced composites. The goal of the research component of the Phase II proposal is to 1) optimize material characteristics using data from Phase I impact testing and conduct numerical modeling using finite element analysis, 2) conduct biochemical evaluation of these advanced materials on designer-enhanced prototypes, 3) perform clinical trials with qualitative analysis based on indepth interviews and focus groups on patients, family members and staff to develop tools to evaluate compliance and decisions to use the product and 4) Develop a standard for headgear protection for patients at risk of same level falls. , ,

Public Health Relevance:
Falls-related traumatic brain injury has become a significant and unrecognized public health issue. There is a need for a new lightweight, attractive, unobtrusive medical headgear that can be customized to the style, needs, comfort and protection to provide higher compliance and application to patient populations that includes older adults with balance impairment, dementia, active seniors on blood thinners, acute care hospital cases at very high risk for falls to reduce the health consequences of falls-related traumatic brain injury. Outcomes tools to evaluate the effectiveness of social marketing and academic detailing will be developed.

Thesaurus Terms:
1-(4'-Hydroxy-3'-Coumarinyl)-1-Phenyl-3-Butanone;2-(Acetyloxy)Benzoic Acid;3-(Alpha-Acetonylbenzyl)-4-Hydroxycoumarin;3-Alpha-Phenyl-Beta-Acetylethyl-4-Hydroxycoumarin;4-Hydroxy-3-(3-Oxo-1-Phenylbutyl)-2h-1-Benzopyran-2-One;Absorption;Academic Detailing;Acetylsalicylic Acid;Acute;Address;Aged 65 And Over;Aging;Amentia;Anticoagulant Agents;Anticoagulant Drugs;Anticoagulants;Anticoagulation;Area;Aspergum;Aspirin;Awareness Of Self;Biochemical;Biomechanics;Cdc;Caring;Centers For Disease Control;Centers For Disease Control (U.S.);Centers For Disease Control And Prevention;Centers For Disease Control And Prevention (U.S.);Cessation Of Life;Characteristics;Chronic;Chronic Disease;Chronic Illness;Clinical Evaluation;Clinical Testing;Clinical Trials;Clinical Trials, Unspecified;Compliance Behavior;Craniocerebral Trauma;Data;Death;Dementia;Development;Devices;Disabled Persons;Disabled Population;Ecotrin;Effectiveness;Elderly;Elderly, Over 65;Elements;Empirin;Entericin;Equilibrium;Evaluation;Extren;Fall Prevention;Family Member;Finite Element Analyses;Finite Element Analysis;Focus Groups;Frail Elderly;Frail Elders;Frail Seniors;Funding;Generations;Goals;Hosp;Handicapped;Head Injuries;Head Trauma;Health;Helmet;Hospitalization;Hospitals;Incidence;Injuries, Craniocerebral;Injury;Interview;Lead;Marketing;Measurin;Medical;Modeling;Mortality;Mortality Vital Statistics;Nih;National Institutes Of Health;National Institutes Of Health (U.S.);Outcome;Patient Compliance;Patient Cooperation;Patients;Pb Element;People With Disabilities;Personal Awareness;Persons;Persons With Disabilities;Phase;Physical Health Services / Rehabilitation;Physiologic;Physiological;Population;Process Of Absorption;Programs (Pt);Programs [publication Type];Protective Devices;Public Health;Qol;Quality Of Life;Rehabilitation;Rehabilitation Therapy;Rehabilitation, Medical;Reporting;Reportings, Hospital Risk;Research;Resistance;Resort;Risk;Risk Management;Risk Reporting, Hospital;Sbir;Sbirs (R43/44);Safety;Self Perception;Self Image;Self View;Senescence;Services;Small Business Innovation Research;Small Business Innovation Research Grant;Social Marketing;Technology;Testing;Training;Trauma, Brain;Traumatic Brain Injury;Traumatic Encephalopathy;Treatment Compliance;United States Centers For Disease Control;United States Centers For Disease Control And Prevention;United States National Institutes Of Health;Vulnerable Populations;Warfarin;Woman;Absorption;Advanced Age;Balance;Balance Function;Base;Blood Thinner;Chronic Disease/Disorder;Chronic Disorder;Clinical Investigation;Clinical Test;Cognitive Change;Compliance Cooperation;Conditioning;Cost;Design;Designing;Disability;Disabled;Disabled People;Elders;Equilibration Disorder;Fall Risk;Falls;Frail Older Adult;Frailty;Geriatric;Heavy Metal Pb;Heavy Metal Lead;High Risk;Improved;Late Life;Later Life;Non-Compliance;Older Adult;Older Person;Patient Adherence;Patient Population;Programs;Prototype;Public Health Medicine (Field);Public Health Relevance;Rehabilitative;Research Clinical Testing;Resistant;Safety Equipment;Self Awareness;Self Knowledge;Senescent;Senior Citizen;Therapy Compliance;Therapy Cooperation;Thrombopoiesis Inhibitor;Tool;Traumatic Brain Damage