R M BEAUMONT CORP — Department of Health and Human Services STTR Phase I: NIA

Description

DESCRIPTION provided by applicant Osteoarthritis OA diagnosed in over of the US population is the primary cause of musculoskeletal lower extremity disability Although there is no cure exercise remains the core treatment to manage OA regardless of age comorbidity pain severity or disability Yet many people with this condition do not engage in regular fitness and thus may resort to invasive and risky joint replacement surgeries due to pain and decreased mobility or they may experience health decline due to sedentary lifestyles The goal of this Phase I STTR proposal is to complete the design safety and usability testing of AFARI tm for use by individuals diagnosed with lower extremity OA Created to fill an unmet need for populations who without adequate mobility support would be less likely fully unable or unwilling to participate in ambulatory exercise AFARI is a three wheeled device and provides the mechanisms to unload body weight AFARI was created to promote participation in outdoor walking jogging or running Although durable medical equipment DME such as walkers crutches and canes is available to those who need it DME is minimally functional for outdoor exercise and is often perceived as stigmatizing and inconvenient Therefore many people with lower extremity OA abandon these devices AFARI was designed to mitigate abandonment and eliminate a number of barriers to regular outdoor fitness activity by persons with lower extremity OA AFARI will allow the user to safely and successfully initiate maintain and or increase the length and intensity of their exercise programs In preliminary market research for AFARI respondents indicated that form was as important as function and ease of use if they were to adopt AFARI and the device was designed with these principles in mind Through this STTR effort several major barriers to timely commercialization of AFARI will be researched so that they can be eliminated The safety and stability of AFARI will be proven though mechanical testing and human evaluation The weight bearing monitoring system will be concurrently validated against bodily weight bearing measures An evaluation of the reduction in fall risk tested by fear of falling will be undertaken Data on usability destigmatizing design and overall desirability of AFARI will be collected and tasks will be planned to educate clinicians regarding AFARI and its benefits To accomplish the objective of this Phase I study to demonstrate the initial feasibility of AFARI for people with lower extremity OA such that we can proceed with expanded efforts in Phase II four specific aims will be met AIM Validation of the functionalit and safety of AFARI AIM Concurrent validation of the weight bearing monitoring system AIM Conducting preliminary usability testing focusing on comfort function convenience stigma reduction and design preferences and AIM Planning for clinician education about AFARI PUBLIC HEALTH RELEVANCE Although osteoarthritis diagnosed in over of the US population and a primary cause of musculoskeletal lower extremity disability has no cure exercise is an efficacious treatment to manage it regardless of age comorbidity pain severity or disability Yet many people with this condition do not engage in regular fitness due in large part to the absence of well designed adaptive mobility devices thereby placing them at risk for costly invasive painful surgeries and or further deterioration in health and fitness To meet the growing need for exercise engagement supported with mobility equipment AFARITM an aesthetically designed mobility assistive device with wireless sensor feedback that provides balance stability and weight bearing assistance to those seeking safe and effective support while participating in outdoor rehabilitation and fitness is proposed