Decreasing Knee Injury Risk Factors With Neuromuscular Training

April 19, 2017 updated by: Ohio University

The Effectiveness of Neuromuscular Training on Modifiable Anterior Cruciate Ligament Injury Risk Factors

Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism, with more than 70% of them occurring while landing from a jump. Female athletes are at higher risk of sustaining a noncontact ACL injury due to the higher number of risk factors that they possess compared to their male counterparts. Due to this statistic, ACL prevention programs have been developed over the past 15 years in attempt to reduce this risk among the female athletic population. These programs have been shown to reduce the rate of noncontact ACL injuries in females by correcting the risk factors associated with them. However, it remains unclear as to whether these positive results are solely due to the program or a higher exercise workload in its participants. The purpose of this study is to evaluate the effectiveness that an ACL prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL injury) compared to a resistance training program of equal workload.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Injury Background Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden on the athlete. The average cost for ACL reconstruction is estimated to be approximately $17,000 per patient and full recovery commonly takes around 6 months to achieve. It has been estimated that 1 in every 3000 people in the United States suffer an ACL rupture each year. Roughly 80% of these injuries are linked to a noncontact mechanism, with more than 70% of them occurring while landing from a jump.

Injury Mechanism Upon landing, the lower body falls into what is referred to as the "position-of-no-return" (PNR). The landing kinematics involved with the PNR places a high amount of stress on the ACL and can ultimately lead to a complete rupture.

Injury Imbalance Female athletes who participate in sports that involve jumping and cutting activities suffer 4-to-6 times more ACL injuries than males who participate in the same sports. This is attributed to the higher number of risk factors that females possess during and after puberty. In particular, upon maturation, males exhibit a neuromuscular spurt, with increases in power, strength, and coordination, whereas females do not. Other risk factors that females demonstrate are quadriceps dominance and ligament dominance. Both of these dominances are linked to the landing kinematics of the knee when placed in the PNR.

Quadriceps dominance is characterized by the extended knee posture that is displayed in the PNR when landing from a jump. When landing on an extended knee, the tibia is translated anteriorly to the femur, causing the ACL to become taunt. In order to prevent the ACL from rupturing, the hamstrings must activate to flex the knee and translate the tibia posteriorly. In response to anterior tibial translation, females are found to utilize a different muscle recruitment pattern than males by contracting their quadriceps before their hamstrings, whereas males follow the opposite pattern. By contracting the quadriceps first, the hamstrings are overpowered, which allows for further anterior tibial translation to occur during landing.

Ligament dominance is evidenced by the increased knee valgus that displayed in the PNR when landing and cutting. During these maneuvers, females rely on their knee ligaments rather than lower extremity musculature to absorb ground reaction forces. This tendency places a high amount of stress on the ACL, which in turn, increases the probability of it rupturing.

Injury Prevention Due to the high rate of noncontact ACL injuries seen in female athletes, neuromuscular training (NMT) programs have been developed in an attempt to prevent or reduce the risk of injury. These programs are administered as either an off-season regimen or in-season warm-up routine, and they incorporate a combination of plyometric, proprioceptive, and strength training exercises, with particular focus being placed on correct technique. By modifying neuromuscular risk factors, NMT programs have been able to significantly reduce the rate of noncontact ACL injury.

Specific Aim 1:

To evaluate the effectiveness that an ACL prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL injury) compared to a resistance training program of equal workload.

Specific Aim 2:

To evaluate the effectiveness that an ACL prevention program has on improving max vertical jump height compared to a resistance training program of equal workload.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 16 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female college underclassman (ages 18-20)
  • Body Mass Index (BM) between 18.5 - 25 (normal range)
  • Blood pressure below 140/90 (below hypertension)
  • History of participation in high school athletics
  • Signed Informed Consent form

Exclusion Criteria:

  • History of ACL injury
  • Current/ongoing knee condition
  • History of surgical intervention within one year (not including facial)
  • Current/ongoing musculoskeletal injury
  • History of previous ACL prevention training
  • Currently involved in intercollegiate athletics
  • Currently Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACL prevention training
Procedure: Neuromuscular and Resistance Training
1 hour/session, 3 sessions/week, 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knee separation during the Drop Jump Test
Time Frame: 1 week prior to training begins, and 1 week after training finishes.
Participants will begin the test by standing on a box, dropping off, landing straight in front of the box, and immediately performing a maximum vertical jump. Following the completion of the three trials, the examiner chooses the trial in which the participant has the highest jump to best represent the participant's jumping ability for video analysis. The following images will be captured as still photographs: (1) pre-landing; (2) land; and (3) takeoff.
1 week prior to training begins, and 1 week after training finishes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Vertical Jump Test
Time Frame: 1 week prior to training begins, and 1 week after training finishes
Each participant's standing reach will be recorded prior to performing the test. The participants will perform three trials, with the highest jump height being recorded. Participants will begin the test by standing directly underneath the Vertec markers and jumping vertically while reaching with their hand to swipe the highest marker possible. Arm swing will be allowed for the jump, but an approach-step will not.
1 week prior to training begins, and 1 week after training finishes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Conrad M Gabler, B.S., Graduate Athletic Training Student
  • Study Director: Brian G Ragan, Ph.D., Athletic Training Program Assistant Professor and Research Coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ohio_U11F024
  • 1104MGP005 (Other Grant/Funding Number: National Athletic Trainers' Association Research & Education Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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