SBIR-STTR Award

Significance: Anterior cruciate ligament (ACL) tears are among the most common sport-related injuries in young athletes, especially females. Anterior cruciate ligament reconstruction (ACLR) surgery is the preferred treatment, yet the re-injury rate is unacceptably high in young athletes who return to sport (RTS) after ACLR. ACL injuries and re-injuries often occur during dynamic foot-ground interactions (e.g., cutting or landing). Deficient neuromus- cular control has been identified as the primary modifiable risk factor contributing to these injuries and re-injuries. Thus, recovery of neuromuscular control of dynamic foot-ground interactions should be a central criterion for safe RTS clearance, but is currently difficult to assess in typical clinical settings. Clinical need: Typical clinical settings lack technology to safely, economically and efficiently quantify recovery of neuromuscular control after ACLR to (i) improve RTS decision-making and (ii) avoid premature RTS. As a result, clearance criteria and success with RTS varies widely across clinical centers. Thus, there is need for a clinically practical means to quantify the recovery of neuromuscular control for RTS after ACLR. Scientific premise: The leg dexterity test safely and quickly quantifies neuromuscular control, correlates with dynamic full weight-bearing athletic agility, and captures sex differences. Thus, it has clear potential as a clinically practical means to quantify recovery of neuromuscular control for RTS decision-making. Rigor: Neuromuscular Dynamics, LLC commercializes simple, quick and safe patented technology shown by 20+ publications to quantify neuromuscular control. The lower-extremity version (i.e., leg dexterity test, Right) consists of asking seated participants to use a single leg to compress an unstable platform atop a slender spring. The spring buckles with low forces at ~15% of body weight, so the greatest mean force subjects can sustain quantifies their neuromuscular control of unstable foot-ground interactions, without exposure to high forces or risky weight-bearing maneuvers. Due to its scientific and technical merit, simplicity, and test/retest reliability, the leg dexterity test has clear potential as a clinical tool to quantify neuromuscular control in the outpatient setting. Goal: Establish the clinical feasibility and utility of using the leg dexterity test as an objective measure of recovery of neuromuscular control after unilateral ACLR across four leading sports rehabilitation centers. Approach: Test 132 patients (16?25 yrs old) longitudinally after unilateral ACLR (i) during rehabilitation and (ii) after achieving RTS clearance. Compare their performance to sex- and skill-dependent normative ranges of leg dexterity measured in 426 (and counting) control subjects matched for age. Aim 1: Asses clinical utility by quantifying the ability of the leg dexterity test to identify altered neuromuscular control of the affected leg after ACLR, and its recovery over time. Hypothesis A: Construct validity: neuromuscular control (as per the leg dexterity test) approaches normative ranges over time. Hypothesis B: Criterion (Concurrent) validity: Current RTS criteria do not fully consider neuromuscular control. The leg dexterity test will identify false negative results in those cleared for RTS (i.e., prematurely cleared for RTS as they do not meet their sex- and skill-specific normative levels of leg dexterity). Aim 2: Test clinical feasibility (is it practical?) and utility (does it provide actionable information?) of using the leg dexterity test on patients in the outpatient clinic. Hypothesis C: The System Usability Scale and a Delphi Panel will show that clinicians find the leg dexterity test clinically feasible and useful to (i) improve RTS decision-making and (ii) avoid premature RTS. Deliverables: This short Phase I project will demonstrate that the leg dexterity test has clinical and scientific value to inform RTS decisions in the outpatient clinical setting. It will also enable the commercialization goals of Phase II by: (i) obtaining feedback from potential end-users to refine the hardware’s design and portability, (ii) custom- izing software and testing protocols for clinical use, (iii) scaling-up our Cloud Analytics platform, (iv) generating reports for clinical reimbursement standards, (v) and identifying leg dexterity metrics that detect deficits in neu- romuscular control at the time of RTS clearance with high sensitivity and specificity. This project will yield a risk- reduced FDA Class I device technology ready for further clinical studies and commercialization.

Public Health Relevance Statement:
Principal Investigator: Christopher Angermayer! PROJECT NARRATIVE Non-contact anterior cruciate ligament (ACL) injuries of the knee are among the most common sport-related injuries in young athletes, especially women. 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 I project seeks to establish the clinical utility and commercial feasibility of leg dexterity as a simple and informative measure of post-surgical recovery of neuromuscular control after ACL reconstruction at the time of return to sport.

Project Terms:
Affect; Age; Ambulatory Care Facilities; Anterior Cruciate Ligament; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; Asses; Athletic; Body Weight; Clinical; Clinical assessments; Clinical Protocols; Clinical Research; commercialization; Computer software; Custom; Decision Making; design; Devices; dexterity; Exposure to; Feedback; Female; foot; Goals; improved; Injury; Knee Injuries; Leg; Legal patent; ligament injury; Lower Extremity; Measures; modifiable risk; neuromuscular; off-patent; Operative Surgical Procedures; Outpatients; Participant; Patients; Performance; Phase; portability; premature; Prevention; Principal Investigator; Publications; Reconstructive Surgical Procedures; Recovery; Rehabilitation Centers; Rehabilitation therapy; Reporting; return to sport; Risk; Risk Factors; scale up; Sensitivity and Specificity; sex; Sex Differences; skills; Small Business Innovation Research Grant; Sports; success; System; Technology; Testing; Time; tool; usability; Weight-Bearing state; Woman

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.

Public Health Relevance Statement:
PROJECT NARRATIVE 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.

Project Terms:
Adopted; Age; Android; Anterior Cruciate Ligament; anterior cruciate ligament injury; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; automated analysis; Bar Codes; Bluetooth; Characteristics; Clinic; Clinical; Clinical assessments; clinical center; clinical efficacy; Clinical Research; Clinical Trials; Cloud Computing; Code; commercialization; computational platform; Computer software; cost; COVID-19; Custom; Data; Data Display; data management; Decision Making; Degenerative polyarthritis; design; Devices; dexterity; early onset; Evolution; foot; Generations; Goals; Health Insurance Portability and Accountability Act; high risk; Human; improved; Industry Standard; Injections; Injury; Institutional Review Boards; Intellectual Property; Knee Injuries; Knee Osteoarthritis; Leg; Legal patent; Logistics; Longitudinal Studies; Measures; Medical; men; Methods; modifiable risk; Molds; neuromuscular; neuromuscular system; Operative Surgical Procedures; Outpatients; Participant; Patients; Performance; Phase; Physical therapy; portability; Preparation; Prevention; printed circuit board; Production; Protocols documentation; Publications; Readiness; Reconstructive Surgical Procedures; Recovery; rehabilitation strategy; Rehabilitation therapy; Reporting; research and development; return to sport; Risk; Risk Factors; scale up; sex; Sex Differences; Site; Small Business Innovation Research Grant; software as a service; Soldier; Source; standard of care; System; Tablet Computer; Tablets; Technology; Testing; Time; tool; usability; Weight-Bearing state; Woman