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.
This project is developing a wearable robotic device called KOAALA (Knee Osteoarthritis (KOA) Active Living Assistant) that monitors and potentially prevents the progression of KOA. Research shows that Knee Adduction 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. KOAALA addresses the monitoring and early intervention of KOA by logging high resolution KAM and gait data during all Activities of Daily Living (ADL). This Phase 1/Phase 1B effort was focused on creating/integrating KAM sensors and a wireless capability into an existing device and bench testing a KOAALA prototype and creating infrastructure for an early stage software application that presents the KAM/gait data to a managing clinician. All the pieces will be perfected, integrated and prototyped during Phase 2. During this Phase 1/Phase 1B effort we obtained the following outcomes: Development of a thin KAM pressure sensor having resolution over a wide dynamic range; Development of scheme for positioning the KAM pressure sensors on the sides of the lower thigh; Six-month wear test of KAM sensor. Development of field installable wireless module showing data transfer rates to a nearby PC. A higher performance clutch controlling component was prototyped and tested. A lower weight, smaller size and improved performance was also invented; A Web based application was created called KOAALAclinic demonstrating the feasibility of presenting gait/KAM data logged by KOAALA to a managing clinician; Prototypes of a new joint connecting KOAALAâ€™s thigh frames containing KAM sensors and upper leg assemblies were prototyped and multiple weeks of wearing KOAALA to assess its comfort and ADL interference level were completed. A rule set governing gait/KAM data medical records privacy and access was developed; Key pieces of the software infrastructure for KOAALAclinic application were demonstrated; Logging gait/KAM sensor data to an on-brace memory card and uploading gait data to third party was demonstrated. Software integrating KOAALAâ€™s new pressure sensors, its wireless module and its gait/KAM logging into KOAALA operating system was created and tested. The work executed during the reporting period provide the foundation of components that will be the basis for completing development of a leg brace and software applications that offers clinicians a new non-pharmacological schema for treating KOA that addresses known problems with existing non-pharmacological treatment methods.