Technology has the potential to accelerate clinical research and reduce the burden of participation in rare diseases such as Duchenne Muscular Dystrophy (DMD). DMD is an x-linked genetic disorder that results in progressive muscle weakness with loss of ambulation by 10-12 years of age, progression of arm weakness resulting in difficulty with self-feeding and other self-care activities in adolescence, and death resulting from cardiopulmonary insufficiency by age 30 years. Studies in rare diseases are inherently difficult due to a small recruitment pool and a limited number of sites that possess the experience and resources to participate as a study site. An outcome measure that quantifies change in both ambulant and non-ambulant individuals with minimal evaluator training could enable more efficient data collection in multi-site clinical trials. Our upcoming submission, DDT COA 0032, Abilities Captured Through Interactive Video Evaluation (ACTIVE), has the potential to meet this need. ACTIVE is a 65-second game utilizing a skeletal-tracking algorithm to quantify workspace volume (WSV) elicited through maximal arm reaching overhead, side-to-side, and forward while also encouraging trunk lean in each direction. Our studies have shown that ACTIVE is valid and reliable in quantifying WSV in persons with DMD across the span of age and abilities. However, to increase access and portability of a tool for use across trial sites, it is critical that tool has sound scientific and technological construction. ACTIVE WSV was originally built upon the Microsoft Kinect and Kinect One for Xbox platforms. The skeletal tracking algorithm developed by Microsoft vastly exceeds all other programs as it had the full backing of the Microsoft machine. Unfortunately, the Kinect, in its additional sense, has been abandoned for more current artificial intelligence applications. The Microsoft Kinect Azure will soon be released with higher resolution and programming capabilities. Our full DDT submission has been delayed as each new camera release has required reprogramming of our software to ensure valid and reliable results. Our team has recently expanded to include software development partners, The Plan Works (thePlan), who have the technological expertise to alter our current codebase to ensure transfer of ACTIVE across camera sensor platforms is more efficient and reliable as we expect ongoing technological advances to provide opportunities for continued advances. To this end, our current application seeks support to verify the technology of the ACTIVE WSV system to 1) confirm the use of unique code that can be ported across platforms over time and 2) improving the ease of use and limit training needed at a growing number of inexperienced centers.
Our upcoming submission, DDT COA 0032, Abilities Captured Through Interactive Video Evaluation (ACTIVE), is a 65-second outcome assessment that quantifies a person?s workspace volume and has the potential to expand the enrollment pool by measuring both ambulant and non-ambulant subjects. While the scientific construction of the tool is sound, ongoing technological advances and changes have made it challenging to port our software across camera platforms. Our proposal seeks funding to support final software updates to ensure changes in technology components (i.e. camera sensor systems) or coding instability will not interfere with clinical trial data collection and allow us to complete our final submission package.
