Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
2 other identifiers
interventional
593
1 country
1
Brief Summary
Females who participate in cutting and landing sports suffer anterior cruciate ligament (ACL) injuries at a 2 to 10-fold greater rate than males participating in the same high-risk sports. Fifty to 100 percent of ACL injured females will suffer osteoarthritis of the injured knee within one to two decades of the injury. External knee abduction moment (LOAD) predicts ACL injury with high sensitivity and specificity in female athletes. Control of lateral trunk motion (LTM) also predicts ACL injury with similar levels of sensitivity and specificity in female athletes. These predictors may be linked, as lateral positioning of the trunk can create high knee abduction load via both biomechanical and neuromuscular mechanisms. The mechanism of ACL injury in females include high knee LOAD and high LTM, with the majority of body weight shifted over the injured limb and the foot positioned lateral to the body's center of mass. An unanticipated perturbation is also often a contributor to the injury mechanism. LTM may result in increased knee LOAD by increasing the lateral position and magnitude of the GRF vector (ΔGRFv) or by increasing reactive hip adductor torque (HAdT). Our long-term objectives are to determine the mechanisms that cause ACL injury in female athletes and to develop neuromuscular training (NMT) interventions that specifically target these mechanisms. If the objectives of this proposal are achieved, an evidence-based NMT intervention will be developed and made available nationally that will effectively and efficiently reduce ACL injury risk in high-risk female athletes. The major goal of this proposal is to determine if increased LTM increases coronal plane knee load in high-risk groups of female athletes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
July 30, 2019
CompletedSeptember 4, 2020
August 1, 2020
4 years
December 16, 2009
January 10, 2017
August 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Decrease in Knee Valgus Measurement
determine biomechanical risk factors for ACL injury and determine if participation in NMT reduces risk factors compared to sham (speed training)
2 years
Study Arms (2)
Neuromuscular Training
EXPERIMENTALCombination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.
Speed Training
NO INTERVENTIONSham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete
Interventions
Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.
Eligibility Criteria
You may qualify if:
- Female
- Soccer, Basketball, or Volleyball athlete
- Attends Middle School or High School in Boone County or Fayette County KY
You may not qualify if:
- Male
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206, United States
Related Publications (1)
Hewett TE, Ford KR, Xu YY, Khoury J, Myer GD. Utilization of ACL Injury Biomechanical and Neuromuscular Risk Profile Analysis to Determine the Effectiveness of Neuromuscular Training. Am J Sports Med. 2016 Dec;44(12):3146-3151. doi: 10.1177/0363546516656373. Epub 2016 Jul 29.
PMID: 27474385DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Timothy Hewett
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy E Hewett, Phd
Children's Hospital Medical Center, Cincinnati
- STUDY DIRECTOR
Kim D Barber Foss, MS
Children's Hospital Medical Center, Cincinnati
- STUDY DIRECTOR
Staci Thomas, Ms
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 4, 2020
Results First Posted
July 30, 2019
Record last verified: 2020-08