NEUROMUSCULAR DYNAMICS LLC — Department of Health and Human Services SBIR Phase I: NIAMS

Description

SignificanceAnterior cruciate ligamentACLtears are among the most common sport related injuries in young athletesespecially femalesAnterior cruciate ligament reconstructionACLRsurgery is the preferred treatmentyet the re injury rate is unacceptably high in young athletes who return to sportRTSafter ACLRACL injuries and re injuries often occur during dynamic foot ground interactionse gcutting or landingDeficient neuromuscular control has been identified as the primary modifiable risk factor contributing to these injuries and re injuriesThusrecovery of neuromuscular control of dynamic foot ground interactions should be a central criterion for safe RTS clearancebut is currently difficult to assess in typical clinical settingsClinical needTypical clinical settings lack technology to safelyeconomically and efficiently quantify recovery of neuromuscular control after ACLR toiimprove RTS decision making andiiavoid premature RTSAs a resultclearance criteria and success with RTS varies widely across clinical centersThusthere is need for a clinically practical means to quantify the recovery of neuromuscular control for RTS after ACLRScientific premiseThe leg dexterity test safely and quickly quantifies neuromuscular controlcorrelates with dynamic full weight bearing athletic agilityand captures sex differencesThusit has clear potential as a clinically practical means to quantify recovery of neuromuscular control for RTS decision makingRigorNeuromuscular DynamicsLLC commercializes simplequick and safe patented technology shown bypublications to quantify neuromuscular controlThe lower extremity versioni eleg dexterity testRightconsists of asking seated participants to use a single leg to compress an unstable platform atop a slender springThe spring buckles with low forces atof body weightso the greatest mean force subjects can sustain quantifies their neuromuscular control of unstable foot ground interactionswithout exposure to high forces or risky weight bearing maneuversDue to its scientific and technical meritsimplicityand test retest reliabilitythe leg dexterity test has clear potential as a clinical tool to quantify neuromuscular control in the outpatient settingGoalEstablish 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 centersApproachTestpatientsyrs oldlongitudinally after unilateral ACLRiduring rehabilitation andiiafter achieving RTS clearanceCompare their performance to sexand skill dependent normative ranges of leg dexterity measured inand countingcontrol subjects matched for ageAimAsses clinical utility by quantifying the ability of the leg dexterity test to identify altered neuromuscular control of the affected leg after ACLRand its recovery over timeHypothesis AConstruct validityneuromuscular controlas per the leg dexterity testapproaches normative ranges over timeHypothesis BCriterionConcurrentvalidityCurrent RTS criteria do not fully consider neuromuscular controlThe leg dexterity test will identify false negative results in those cleared for RTSi eprematurely cleared for RTS as they do not meet their sexand skill specific normative levels of leg dexterityAimTest clinical feasibilityis it practicaland utilitydoes it provide actionable informationof using the leg dexterity test on patients in the outpatient clinicHypothesis CThe System Usability Scale and a Delphi Panel will show that clinicians find the leg dexterity test clinically feasible and useful toiimprove RTS decision making andiiavoid premature RTSDeliverablesThis short Phase I project will demonstrate that the leg dexterity test has clinical and scientific value to inform RTS decisions in the outpatient clinical settingIt will also enable the commercialization goals of Phase II byiobtaining feedback from potential end users to refine the hardware s design and portabilityiicustomizing software and testing protocols for clinical useiiiscaling up our Cloud Analytics platformivgenerating reports for clinical reimbursement standardsvand identifying leg dexterity metrics that detect deficits in neuromuscular control at the time of RTS clearance with high sensitivity and specificityThis project will yield a riskreduced FDA Class I device technology ready for further clinical studies and commercialization Principal InvestigatorChristopher Angermayer! PROJECT NARRATIVE Non contact anterior cruciate ligamentACLinjuries of the knee are among the most common sport related injuries in young athletesespecially womenUnderstanding the state of recovery of neuromuscular control is critical to return to sport decisions and prevention of re injuryThe leg dexterity test is a simple and safe way to evaluate dynamic neuromuscular control of foot ground interactionsThis 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