Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01034527
First received: December 16, 2009
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention
ACL Injury
Other: Neuromuscular Training
Other: Speed Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Optimize the effectiveness of interventions designed to prevent ACL injuries [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 593
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01034527

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01034527     History of Changes
Other Study ID Numbers: 2009-0602, 5R01AR055563
Study First Received: December 16, 2009
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Anterior Cruciate Ligament
Female Athlete
Sports Injuries
Injury Prevention

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014