ACLNCT01433718
Decreasing Knee Injury Risk Factors With Neuromuscular Training
A study testing Neuromuscular and Resistance Training in people with ACL and Anterior Cruciate Ligament Injury, run by Ohio University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACL, Anterior Cruciate Ligament Injury
- What is being tested?
- Neuromuscular and Resistance Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ACL, Anterior Cruciate Ligament Injury
- Being tested
- Neuromuscular and Resistance Training
- Keywords
- Effectivness, Neuromuscular Training, Resistance Training, Modification, Anterior Cruciate Ligament Risk Factors, Drop-Jump, Knee Separation, Resistance training program
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular and Resistance TrainingProcedure or surgery
1 hour/session, 3 sessions/week, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| ACL prevention training | Experimental | Not described Receives: Procedure: Neuromuscular and Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee separation during the Drop Jump Test
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.
Measured: 1 week prior to training begins, and 1 week after training finishes.
Secondary outcomes (1)
Changes in Vertical Jump Test
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.
Measured: 1 week prior to training begins, and 1 week after training finishes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Responsible party
- Sponsor
- Investigators
- Conrad M Gabler, B.S., Principal investigator, Graduate Athletic Training StudentBrian G Ragan, Ph.D., Study director, Athletic Training Program Assistant Professor and Research Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433718
- Sponsor's protocol ID
- Ohio_U11F024
- Other IDs
- 1104MGP005
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2011
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuromuscular Training on Modifiable Anterior Cruciate Ligament Injury Risk Factors
- ClinicalTrials.gov ID
- NCT01433718
- Acronym / sponsor ID
- Ohio_U11F024
- Conditions
- ACL, Anterior Cruciate Ligament Injury
- Keywords
- Effectivness, Neuromuscular Training, Resistance Training, Modification, Anterior Cruciate Ligament Risk Factors, Drop-Jump, Knee Separation, Resistance training program
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL prevention training | Experimental | Procedure: Neuromuscular and Resistance Training |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular and Resistance Training1 hour/session, 3 sessions/week, 6 weeks | Procedure or surgery | ACL prevention training |
Primary outcome
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 secondary outcome
Changes in Vertical Jump Test
Time frame: 1 week prior to training begins, and 1 week after training finishes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conrad M Gabler, B.S. principal investigator
Graduate Athletic Training Student
Brian G Ragan, Ph.D. study director
Athletic Training Program Assistant Professor and Research Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular and Resistance Training in people with ACL and Anterior Cruciate Ligament Injury, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee separation during the Drop Jump Test (time frame: 1 week prior to training begins, and 1 week after training finishes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.