Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. This application will test the central hypotheses that LTM increases knee LOAD and that NMT that is targeted toward increasing coronal plane control of trunk motion will decrease knee LOAD in females with moderate and high knee LOAD. Aim 1 is designed to determine the mechanisms by which trunk motion may increase knee LOAD in female athletes. Coronal plane control of the trunk (LTM) will be examined relative to ΔGRFv, HAdT and knee LOAD. We will determine if increased LTM increases knee LOAD by biomechanical (increased ΔGRFv) and/or neuromuscular (increased relative HAdT) mechanisms that may underlie increased LOAD in female athletes. The central hypothesis of Aim 1 is that increased LTM will increase knee LOAD in female athletes by increasing ΔGRFv, by increasing HAdT or via a combination of these mechanisms during cutting and landing. We hypothesize that females with neither mechanism will have low knee LOAD, those with increased ΔGRFv or HAdT will have moderate LOAD and those with increased ΔGRFv and HAdT will have high knee LOAD. Aim 2 is designed to determine if NMT that decreases coronal plane trunk motion will decrease knee LOAD in knee load group clusters in a randomized controlled trial. The central hypothesis of Aim 2 is that NMT will decrease knee LOAD in the moderate LOAD group by decreasing ΔGRFv or HAdT and will decrease LOAD to the greatest extent in the high LOAD group by decreasing both ΔGRFv and HAdT.

Condition or disease	Intervention/treatment	Phase
ACL Injury	Other: Neuromuscular Training; Other: Speed Protocol	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	593 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female
Study Start Date :	June 2009
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Neuromuscular Training; Combination 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.	Other: Neuromuscular Training; 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.
Sham Comparator: Speed Training; Speed training protocol Sham 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	Other: Speed Protocol; Sham 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

Outcome Measures

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Primary Outcome Measures :

1. Optimize the effectiveness of interventions designed to prevent ACL injuries [ Time Frame: 2 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	10 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Female
• Soccer, Basketball, or Volleyball athlete
• Attends Middle School or High School in Boone County or Fayette County KY

Exclusion Criteria:

• Male

Contacts and Locations

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Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

National Institutes of Health (NIH)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2016 Jul 29.

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01034527 History of Changes
Other Study ID Numbers:	2009-0602; 5R01AR055563 ( U.S. NIH Grant/Contract )
First Posted:	December 17, 2009
Last Update Posted:	March 26, 2014
Last Verified:	March 2014

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Anterior Cruciate Ligament; Female Athlete; Sports Injuries; Injury Prevention

Additional relevant MeSH terms:

Anterior Cruciate Ligament Injuries; Knee Injuries; Leg Injuries; Wounds and Injuries; Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents	Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors