Friday, April 19, 2024 4/19/2024

A simple and quantitative clinical assessment of neuromuscular recovery after ACL injury

Award Number: R44AR074859
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

View Award Abstract

PROJECT ABSTRACT 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $417,624 )
2022	2022	NEUROMUSCULAR DYNAMICS LLC	3720 CLIFTON PL	MONTROSE	CA	91020	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	7/21/2022	NON-COMPETING CONTINUATION	$417,624
2022	2021	NEUROMUSCULAR DYNAMICS, LLC	3720 CLIFTON PL	MONTROSE	CA	91020	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	10/27/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $417,624

Issue Date FY: 2021 ( Subtotal = $450,762 )
2021	2021	NEUROMUSCULAR DYNAMICS, LLC	3720 CLIFTON PL	MONTROSE	CA	91020	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	8/6/2021	NON-COMPETING CONTINUATION	$450,762
														Subtotal = $450,762

Issue Date FY: 2020 ( Subtotal = $715,833 )
2020	2020	NEUROMUSCULAR DYNAMICS, LLC	3720 CLIFTON PL	MONTROSE	CA	91020	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/11/2020	COMPETING CONTINUATION	$715,833
														Subtotal = $715,833

Grand Total All Awards = $1,584,219

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A simple and quantitative clinical assessment of neuromuscular recovery after ACL injury

Award Number: R44AR074859

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer