Development of Headwear To Prevent Fall-Related Injuries in Elderly Persons

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AG033936-01
Agency Tracking Number: AG033936
Amount: $156,592.00
Phase: Phase I
Program: SBIR
Awards Year: 2009
Solitcitation Year: 2009
Solitcitation Topic Code: N/A
Solitcitation Number: PHS2009-2
Small Business Information
Duns: 825209518
Hubzone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (207) 467-0934
Business Contact
Phone: (207) 467-0934
Research Institution
DESCRIPTION (provided by applicant): 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.

* information listed above is at the time of submission.

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