Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01034527|
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : March 26, 2014
|First Submitted Date ICMJE||December 16, 2009|
|First Posted Date ICMJE||December 17, 2009|
|Last Update Posted Date||March 26, 2014|
|Study Start Date ICMJE||June 2009|
|Actual Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Optimize the effectiveness of interventions designed to prevent ACL injuries [ Time Frame: 2 years ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01034527 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes|
|Official Title ICMJE||Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female|
|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.|
Rationale Aim 2 This aim will determine how NMT targeted to LTM and its two knee loading mechanisms, ΔGRFv and HAdT, will affect knee LOAD in low, moderate and high LOAD subgroups of female athletes.
Central Hypotheses Aim 2 NMT will increase control of coronal plane trunk motion and decrease knee LOAD by either mechanical (ΔGRFv), neuromuscular (HAdT) or both mechanisms and pre-test low, moderate and high knee LOAD subgroups of female athletes will demonstrate differential effects of NMT.
Hypothesis 2.1 Knee LOAD will be lower in trained than untrained females during landing and cutting.
Hypothesis 2.2 Post-test knee LOAD will not differ in trained high, moderate and low knee LOAD subgroups. Hypothesis 2.3 Post-test ΔGRFv and HAdT will not differ in trained high, moderate and low LOAD subgroups.
Hypothesis 2.3 Post-test knee LOAD, ΔGRFv and HAdT values will not differ from pre-test values in untrained high, moderate and low knee LOAD subgroups.
Program Director/Principal Investigator (Last, First, Middle): Hewett, Timothy, Edwin PHS 398/2590 (Rev. 11/07) Page Continuation Format Page
A. Specific Aims The Specific Aims have not been modified from the original application. Our long-term goals are to determine the mechanisms by which female athletes become more susceptible to ACL injury and to develop interventions that address these mechanisms in order to reduce knee loads and ACL injury risk. The major goal of this proposal is to determine if decreased neuromuscular control of the trunk increases coronal plane knee load in high-risk groups of females. This overall objective of this application is to test the central hypotheses that lateral trunk motion increases knee load and that neuromuscular training that increases control of trunk motion will decrease knee abduction loading in females with moderate and high knee loads. Our rationale for this project is that its successful completion will provide a strong, evidence-based intervention that will effectively decrease ACL injury risk in high-risk female athletes.
B. Studies and Results
We continue to utilize a prospective randomized controlled design for Specific Aims 1 and 2 as outlined in the original funded application. The Boone County Superintendent and the Boone County School Board approved the participation (testing, busing, randomized intervention, etc) of the school systems' girls' athletic programs (Basketball, Soccer and Volleyball) at their monthly school board meeting on Thursday, June 11, 2009 and pre-testing began on September 1, 2009. As outlined, school-sponsored basketball, soccer and volleyball teams from the Boone County, Kentucky school system have been and are almost completely recruited, tested and tracked. Testing will be completed by December 31, 2010. Female subjects from all the county high school and junior high schools are being screened prior to the start of their basketball and soccer and volleyball seasons.
A total of 23 teams yielding 318 basketball players have been pre-screened and trained and post-screened September 1, 2009 through April 30, 2010. A total of 29 teams of approximately 306 soccer and volleyball players (31 of which were not new athletes and were tested in prior basketball season) were pre-screened, trained and post-screened between May 2010 and December 2010. We have faced challenges recruiting soccer players at the junior high school level in the county school system. Some of the junior high schools do not have organized soccer teams. We are addressing this challenge by recruiting volleyball teams within the county in order to fill in all of our randomized blocks. In addition, we will capture those athletes that will go on to play high school soccer, volleyball and basketball within the Fayette county school system (see supplement summary below). Thus far, we have enrolled and pretested (N=31 tested for both seasons) and tested a total of 593 athletes for our randomized controlled trial from 9/1/09 through 12/31/10. The breakdown by sport and school level is summarized in the Enrollment Table. There were 558 athletes made the cuts on their respective teams who were randomized by cluster (team) into the intervention. This number includes all athletes who completed at least 1 intervention training session.
For the initial biomechanical analyses, we have chosen to focus on Hypothesis 1.4 with the use Latent Profile Analysis (LPA). We will use LPA to examine whether we can cluster subjects with similar characteristics of the GRFv, HAdT, hip moments (minimum and maximum), lateral trunk motion and center of gravity displacement into distinct neuromuscular profiles. Our latent profile analyses will evaluate independent variables across the multiple tasks to form groups of girls with similar neuromuscular patterns for these variables where the heterogeneity of response pattern is minimized within each profile and maximized across profiles. Initially, two profiles are specified for the LPA model, then, in a stepwise fashion, the number of profiles specified is increased by one. At each step, changes in Bayesian information criteria (BIC), adjusted for sample size, is used to assess model fit and identify the number of profiles needed. The point at which the number of profiles is deemed adequate is when no significant drop in BIC is seen when the profile number is increased. In addition, the Lo-Mendell-Rubin adjusted likelihood ratio test is used to determine the optimal number of profiles.(Lo 2001) The analysis was implemented using Mplus 5.(Muthen 2007) Validation of profile group includes examination as an independent predictor of LOAD.
Analysis has begun and profiles have been created for the pre-test movements. Graphs depicting the standardized means along with the 2 generalized profiles are shown in Figure 1. For presentation purposes it is necessary to show the standardized values as the variables are on different scales, with hugely varying mean values. Due to the underlying normality assumption, it was necessary to transform the lateral trunk motion variable to the loge scale. In addition, it is necessary to account for the correlation between some of these variables; in particular maximum hip moment and GRFv and HAdT. We are continuing to examine the potential LPA models at this time and will be checking them against the post intervention data to determine any emergent profiles. Comparison of mean KAM, with and without adjustment for age and pubertal status by profile will also be the focus of future analyses.
Figure 1. Profile analysis of Pre-Test Data Set (N=457) In addition, we have performed this initial assessment of the efficacy of the Randomized controlled intervention and will be presenting these initial results (The effect of Trunk focused Neuromuscular training on Hip Strength) at a national meeting this coming July.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Condition ICMJE||ACL Injury|
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||June 2013|
|Actual Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||10 Years to 19 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01034527|
|Other Study ID Numbers ICMJE||2009-0602
5R01AR055563 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Children's Hospital Medical Center, Cincinnati|
|Study Sponsor ICMJE||Children's Hospital Medical Center, Cincinnati|
|PRS Account||Children's Hospital Medical Center, Cincinnati|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP