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Clinically Assessed Risk Factors for a Second ACL Injury Using an Innovative Wearable Sensor – Diversity Supplement

Award Number: R01AR078811
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Clinically Assessed Risk Factors for a Second ACL Injury Using an Innovative Wearable Sensor Project Summary Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3 billion. While reconstruction and subsequent rehabilitation allow these athletes to return to sports, they have a 15-fold increased risk of sustaining a second ACL injury, a tear of the ACL graft or the contralateral ACL, upon returning to sports. Many patients cleared to return to sport by their physicians demonstrate residual muscle weakness, as well as asymmetrical movement and loading patterns. Therefore, we contend that the underlying problem with current clinical return to sport decision making is the lack of evidence-based load asymmetry assessment methods that can be collected in a clinical setting. Evidence about the clinical relevance of asymmetry has been collected in research-based motion capture labs. It is not feasible to include costly and time intensive motion capture data collection in clinical settings. Despite laboratory-based evidence that asymmetries (landing and muscle strength) increase the risk of a second ACL injury, these measures are not able to be assessed in clinical settings to determine return to sport readiness. Our study has the potential to significantly impact post-ACL clinical care by identifying the combination of traditional clinical and novel clinic-based return to sport measures that identify patients at high risk for a second ACL injury and achieve our long-term goal of decreasing the number of ACL re-tears through targeted interventions. Specifically, we propose to evaluate load asymmetry in the clinical setting using a new load-sensing insole to determine the predictive associations of an innovative set of clinic-based functional load symmetry measures. We will then develop a prognostic model from a comprehensive set of traditional clinical measures (clinical characteristics and neuromuscular performance) and the proposed novel clinical assessments (psychological/ behavioral readiness and functional load symmetry) to predict second ACL injury. We will recruit 240 ACL reconstructed patients for model development and 120 ACL reconstructed patients for external validation (14-25 years old) who have been released to return to sports. Clinician assessed, patient reported, and load asymmetry measures will be collected in a clinic-like setting. All patients will complete injury surveillance for 18 months following return to sport (24 months following ACL reconstruction). The goals of this observational study are to: 1) Assess whether functional load symmetry measures significantly improve predictive accuracy for a second ACL injury over current standard of care clinical measures used in RTS decisions; and 2) Develop a prognostic model from a comprehensive set of traditional clinical measures (clinical characteristics and neuromuscular performance) and novel clinical assessments (psychological/ behavioral readiness and functional load symmetry) to predict second ACL injury. Study findings will set the stage for future randomized multi-center studies to determine methods for decreasing the number of second ACL injuries through targeted interventions.


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: 2024 ( Subtotal = $743,628 )
2024	2024	VIRGINIA POLYTECHNIC INSTITUTE & STATE UNIVERSITY	300 TURNER ST NW	BLACKSBURG	VA	24060	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	6/24/2024	NON-COMPETING CONTINUATION	$622,479
2024	2024	VIRGINIA POLYTECHNIC INSTITUTE & STATE UNIVERSITY	300 TURNER ST NW	BLACKSBURG	VA	24060	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	8/1/2024	SUPPLEMENT FOR EXPANSION	$121,149
														Subtotal = $743,628

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2023	VIRGINIA POLYTECHNIC INSTITUTE & STATE UNIVERSITY	300 TURNER ST NW	BLACKSBURG	VA	24060	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	2	7/21/2023	SUPPLEMENT FOR EXPANSION	-$133,222
2023	2023	VIRGINIA POLYTECHNIC INSTITUTE & STATE UNIVERSITY	300 TURNER ST NW	BLACKSBURG	VA	24060	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	7/14/2023	SUPPLEMENT FOR EXPANSION	$133,222
2023	2022	VIRGINIA POLYTECHNIC INSTITUTE & STATE UNIVERSITY	300 TURNER ST NW	BLACKSBURG	VA	24060	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	7/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $639,216 )
2022	2022	VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY	300 TURNER ST NW STE 4200	BLACKSBURG	VA	24061	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	6/2/2022	NON-COMPETING CONTINUATION	$639,216
														Subtotal = $639,216

Issue Date FY: 2021 ( Subtotal = $655,644 )
2021	2021	VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY	300 TURNER ST NW STE 4200	BLACKSBURG	VA	24061	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/28/2021	NEW	$655,644
														Subtotal = $655,644

Grand Total All Awards = $2,038,488

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Clinically Assessed Risk Factors for a Second ACL Injury Using an Innovative Wearable Sensor – Diversity Supplement

Award Number: R01AR078811

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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