This Small Business Innovation Research (SBIR) Phase I project develops a leg-brace that monitors, and potentially prevents the progression of Knee Osteoarthritis (KOA). Research shows that Knee Adduction/abduction Moment (KAM) is a key marker in KOA progression and a valuable tool in managing treatment, but is difficult and expensive to measure with existing techniques for all but the simplest activities. The proposed brace addresses the monitoring and early intervention of KOA by producing high resolution KAM and gait data during all Activities of Daily Living (ADL) and easing customer acceptance of wearing robotic devices by minimizing the device's ADL interference, while making it easier to walk with less fatigue. It also limits the maximum knee joint force (potentially slowing KOA progression, as repetitive high knee joint loadings are believed to exacerbate KOA); Phase I research objectives include: create/integrate KAM sensors and a wireless capability into an existing device; bench test a prototype brace; compare the brace's KAM/gait parameter measurements against existing KAM/gait measurement techniques; and create an early stage infrastructure software application that presents the KAM/gait data to managing clinicians. Anticipated results include demonstrating feasibility of software development and that measured KAM data compares favorably to existing measurement techniques. The broader impact/commercial potential of this project stems from its impact on KOA, a disease causing mobility dysfunction amongst an estimated 12% of the world's elderly population. Existing medical management of KOA is difficult in part because there is no low cost procedure for monitoring KOA progression. Treatment typically occurs after KOA begins interfering with Activities of Daily Living, via a staged process starting with training programs with the goal of reducing the tibiofemoral force on the diseased knee compartment for mild cases, progressing to drugs and offloading braces for moderate pain cases and ending with a Total Knee Replacement (TKR) when the pain becomes severe. Total cost to the US health system for the 500K TKR procedures done in 2010 was $17.5B with projections of 3.5M TKR procedures costing $139B by 2030. A conventional vaccine for KOA currently does not exist; the proposed assistive technology is tantamount to a robotic vaccine with promise to slow KOA progression by reducing tibiofemoral force. A highly advanced leg brace, it also provides new tools for rehabilitation clinicians managing symptomatic KOA pain via training programs in remote settings. A successful project will enable researchers to address one of the world's major health problems
