Anterior cruciate ligament (ACL) tears are one of the most common knee injuries and often occur during dynamic foot-ground interactions. ACL reconstructive surgery paired with physical therapy is the standard of care. However, there is a high risk of re-injury even after rehabilitation and clearance to return to full unrestricted activity (RTA). This is because methods of rehabilitation and criteria to evaluate RTA are not standardized to evaluate deficiency in neuromuscular control of the leg (i.e., leg dexterity). Current tests for leg dexterity are not quantitative and are often risky as they require performing dynamic weight-bearing maneuvers. Also, neuromuscular control differs between sexes, and women have a 6-10 times greater risk of ACL injury. There is no test that can quantify leg dexterity simply and safely in the outpatient setting to determine RTA readiness in women and men. Neuromuscular Dynamics, LLC (NMD) developed the leg version of the Valero Dexterity Test?. It effectively quantifies the neuromuscular system control of dynamic foot-ground interactions without exposing the patient to large forces or full-weight bearing maneuvers. It can detect deficits in neuromuscular control, sex differences in it, and inform rehabilitation strategies and RTA readiness. In Phase I we developed a portable, battery-operated Leg Dexterity Test device, improved tablet UI/UX, and deployed a cloud-computing platform. We also manufactured medical grade compression springs, identified reimbursement codes and the regulatory path for this Class I, FDA 510(k) exempt device. We also demonstrated proof-of-concept that the Leg Dexterity Test can measure leg dexterity and confirmed the hypothesis that patients have disrupted dexterity after being cleared for RTA. The system was enthusiastically adopted by clinicians and rated as excellent in Usability Score. Moreover, we demonstrated ability to implement a single IRB protocol across 4 clinical centers. Phase II will optimize manufacturing and cloud computing at scale and demonstrate clinical efficacy of Leg Dexterity Test to inform rehabilitation and improve RTA decision making.
Aim 1 : Manufacturing and firmware will be optimized.
In Aim 2 : Tablet software will be improved.
Aim 3 : Software-as-a-service and cloud computing will be implemented to automate analytics and data display for report generation.
Aim 4 : A 3-year longitudinal study will follow patients from ACL injury through clearance, and test control subjects to establish healthy levels of leg dexterity to inform clearance and to determine rates of recovery.
These Aims will develop a commercialization-ready Leg Dexterity Test and demonstrate its efficacy in optimizing rehabilitation and informing RTA decisions.
Anterior cruciate ligament (ACL) injuries of the knee are among the most common injuries in athletes, active non-athletes, and soldiers. Understanding the state of recovery of neuromuscular control is critical to return to sport decisions and prevention of re-injury. The Leg Dexterity Test is a simple and safe way to evaluate dynamic neuromuscular control of foot-ground interactions. This SBIR Phase II project seeks to optimize the hardware and software technology and to perform a longitudinal clinical study of the Leg Dexterity Test as a simple and informative measure of post-surgical recovery of neuromuscular control after ACL reconstruction at the time of return to activity.
