Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
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| First Received Date ICMJE | December 16, 2009 | ||||||||||||
| Last Updated Date | December 16, 2009 | ||||||||||||
| Start Date ICMJE | June 2009 | ||||||||||||
| Estimated 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 ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| 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 | ||||||||||||
| Descriptive Information | |||||||||||||
| 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. |
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| Detailed Description |
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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | ACL Injury | ||||||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 1104 | ||||||||||||
| Estimated Completion Date | June 2013 | ||||||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 10 Years to 19 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01034527 | ||||||||||||
| Other Study ID Numbers ICMJE | 2009-0602, 5R01AR055563 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Timothy Hewett, Phd, Cincinnati Children's Hospital Medical Center | ||||||||||||
| Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||||||||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||||||||||
| Verification Date | June 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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