Neuromuscular Rehabilitation for ACL Injury Prevention in Athletes

Recruiting at 5 trial locations

Overseen By Nathan Schilaty, DC, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Previous knee surgery, Complex meniscus tears, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL) injury in vulnerable populations (active athletes between 14 = 24 years old) through the identification of relative injury risk groups based on subject-specific movement patterns prior to second injury, as well as through the determination of effect for differential rehabilitation protocols following initial ACL reconstruction and prior to return to sport. As nearly one-third of athletes who have a primary ACL injury and return to sport will experience a secondary injury, results from the proposed work will allow us to prospectively identify high risk patients who are the most appropriate recipients of enhanced treatment, including targeted training, which may reduce the risk of second ACL injury. Secondary ACL injury has the potential to end athletic careers, promote the development of osteoarthritis, and have debilitating effects on quality of life. Hence, the information gathered in this investigation will offer ACL injured athletes the optimal potential to reduce or potentially prevent these negative health effects before they are initiated.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Neuromuscular Intervention for ACL injury prevention in athletes?

Research shows that neuromuscular training (NMT) is effective in reducing the risk of ACL injuries, especially in female athletes. Studies indicate that these programs help improve movement patterns and reduce injury risk, although the best practices for these programs are still being refined. ^{1 2 3 4 5}

Is neuromuscular training safe for humans?

The research does not specifically address safety concerns, but neuromuscular training is widely studied for preventing ACL injuries in athletes, suggesting it is generally considered safe. ^{1 2 3 6 7}

How is the neuromuscular intervention treatment different from other treatments for ACL injury prevention?

Neuromuscular intervention (NMT) is unique because it focuses on training the body's nervous and muscular systems to improve movement patterns and reduce the risk of ACL injuries, especially in athletes. Unlike other treatments that may focus on post-injury rehabilitation, NMT is preventive and aims to correct high-risk landing mechanics and enhance knee function before injuries occur. ^{1 2 5 8 9}

Research Team

Aaron J Krych, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for active athletes aged between 14 and 24 who have had their first ACL injury within the last 6 months. They should not have had previous knee surgeries, complex meniscus tears, or other recent injuries that required medical care. Participants must have been involved in sports requiring cutting, jumping, or pivoting for at least 50 hours a year.

Inclusion Criteria

Pre-injury participation in cutting, jumping or pivoting sports for ≥ 50 hours/year

I haven't had a lower back or leg injury requiring medical care in the year before my ACL injury.

Mechanism of injury did not involve a direct blow to the knee

Exclusion Criteria

It has been over 6 months since I injured my ACL.

I injured my knee from a direct hit.

My knee is unstable due to an untreated MCL injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo different rehabilitation protocols including HOME, STAN, and TNMT over a six-week period

6 weeks

12 sessions (in-person) for STAN and TNMT groups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of knee kinematics and kinetics

5 years

Treatment Details

Interventions

• Neuromuscular Intervention

Trial Overview The study aims to reduce second ACL injuries by identifying high-risk individuals based on movement patterns and testing different rehab protocols after initial ACL reconstruction. The interventions being tested are HOME (home-based exercises) and TNMT (targeted neuromuscular training).

Participant Groups

Group I: Intervention Group with Neuromuscular Training Experimental Treatment 1 Intervention

Patients who are enrolled in the TNMT group will participate in 12 sessions of supervised outpatient physical therapy over a six week period. The TNMT protocol is distinguished by performance of exercises designed to enhance core and hip strength, performance of neuromuscular training exercise that are designed to correct movement flaws associated with second ACL injury25, providing verbal and visual feedback and performance of single leg drills on both legs.

Group II: Control Group Experimental Treatment 1 Intervention

HOME Program is distinguished by patients participating in a home only intervention that consists of running and strengthening exercises performed twice a week for six weeks. No plyometric or agility drills are performed in this study arm. This represents the minimal intervention to prepare for a return to sports. No neuromuscular training or movement training beyond the sagittal plane will be performed.

Group III: Standard of Care Group Active Control 1 Intervention

Patients in the STAN group will participate in twelve sessions of supervised physical therapy over a six week period. Patients will participate in agility and plyometric drills, and continue strength exercises from the previous treatment phase. The clinic program will be performed in conjunction with a home running program. Patients in this group will not receive feedback from the therapist regarding movement quality during activities.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

A systematic review of 14 studies found that longer durations and higher frequencies of neuromuscular training (NMT) significantly reduce the risk of ACL injuries in female athletes, with odds ratios indicating better outcomes for longer training sessions (OR 0.35) and multiple training sessions (OR 0.35).

The analysis revealed an inverse dose-response relationship, suggesting that as the volume of NMT increases, the effectiveness in preventing ACL injuries also increases, highlighting the importance of tailored training programs for optimal injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosage effects of neuromuscular training intervention to reduce anterior cruciate ligament injuries in female athletes: meta- and sub-group analyses. Sugimoto, D., Myer, GD., Foss, KD., et al.[2022]

In a systematic review of 18 studies involving 27,231 participants, neuromuscular training (NMT) programs significantly reduced the risk of ACL injuries, improving the odds from 1 in 54 to 1 in 111, particularly for middle and high school athletes.

The study identified effective components of NMT programs, such as trained implementers and exercises focusing on lower body strength and landing stabilization, and developed a checklist to help practitioners assess and enhance their ACL injury prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Best-Practice Guidelines for Preventing Anterior Cruciate Ligament Injuries in Young Female Athletes: A Systematic Review and Meta-analysis. Petushek, EJ., Sugimoto, D., Stoolmiller, M., et al.[2020]

A meta-analysis of 14 clinical trials showed that integrative neuromuscular training (NMT) significantly reduces ACL injuries in female athletes, with an odds ratio of 0.54, indicating a strong protective effect compared to control groups.

The study found that initiating NMT in early adolescence is particularly effective, as younger participants (mid-teens) experienced a much lower incidence of ACL injuries (OR 0.28) compared to those in late teens and early adulthood, suggesting that early intervention may optimize injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of age on the effectiveness of neuromuscular training to reduce anterior cruciate ligament injury in female athletes: a meta-analysis. Myer, GD., Sugimoto, D., Thomas, S., et al.[2022]

Neuromuscular training programs can significantly reduce the risk of noncontact anterior cruciate ligament (ACL) injuries in female athletes, with a relative risk reduction of 70%, meaning that these programs are highly effective in preventing injuries.

To prevent one ACL injury over a competitive season, approximately 89 female athletes need to participate in these training programs, indicating a clear benefit from implementing such interventions in sports settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular control training programs and noncontact anterior cruciate ligament injury rates in female athletes: a numbers-needed-to-treat analysis. Grindstaff, TL., Hammill, RR., Tuzson, AE., et al.[2022]

An 8-week neuromuscular training program significantly improved landing biomechanics in 24 male athletes who had undergone ACL reconstruction, leading to safer movement patterns that reduce the risk of re-injury.

Participants in the training group showed enhanced knee proprioception and improved patient-reported function, as indicated by increased IKDC scores, while the control group showed no changes, highlighting the efficacy of the training program post-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a neuromuscular training program using external focus attention cues in male athletes with anterior cruciate ligament reconstruction: a randomized clinical trial. Ghaderi, M., Letafatkar, A., Thomas, AC., et al.[2021]

Targeted neuromuscular training (TNMT) significantly improved hip and trunk biomechanics in female athletes, particularly increasing hip external rotation moments and altering trunk flexion and extension, which are important for reducing ACL injury risk.

Athletes identified as high-risk for ACL injuries showed greater improvements from TNMT compared to lower-risk athletes, suggesting that TNMT may be more effective for those at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Neuromuscular Training Based on the Neuromuscular Risk Profile. Hewett, TE., Ford, KR., Xu, YY., et al.[2022]

In a study involving 547 female athletes across 52 teams, compliance with a neuromuscular training (NMT) program aimed at reducing knee injuries was found to be higher in the experimental group compared to the control group, with coaches in the experimental group showing significantly better compliance.

While nearly 90% of athletes completed at least two-thirds of the NMT sessions, coach compliance was notably higher at the high school level than at the middle school level, indicating a need for improved coach engagement in NMT interventions, especially for younger athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive Neuromuscular Training for Young Female Athletes: Comparison of Coach and Athlete Compliance Rates. Sugimoto, D., Mattacola, CG., Bush, HM., et al.[2018]

A systematic review and meta-analysis of 14 studies involving around 27,000 participants found that neuromuscular and educational interventions can reduce the incidence of ACL injuries by approximately 50%.

The effectiveness of these interventions varied significantly across studies, with stronger effects observed in non-randomized studies, those conducted in the U.S., and among soccer players, indicating that factors like study design and participant characteristics may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions designed to prevent anterior cruciate ligament injuries in adolescents and adults: a systematic review and meta-analysis. Gagnier, JJ., Morgenstern, H., Chess, L.[2022]

A neuromuscular training (NMT) program significantly improved hip biomechanics in athletes after anterior cruciate ligament (ACL) reconstruction, as evidenced by increased International Knee Documentation Committee (IKDC) scores and better landing mechanics after 12 training sessions.

Despite improvements in overall hip biomechanics, the specific hip abduction angle and external rotation moment did not show significant changes in the involved limbs, suggesting that while NMT can enhance control and reduce injury risk, further targeted interventions may be needed for specific biomechanical deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Training Improves Self-Reported Function and Single-Leg Landing Hip Biomechanics in Athletes After Anterior Cruciate Ligament Reconstruction. Nagelli, C., Di Stasi, S., Tatarski, R., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dosage effects of neuromuscular training intervention to reduce anterior cruciate ligament injuries in female athletes: meta- and sub-group analyses. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evidence-Based Best-Practice Guidelines for Preventing Anterior Cruciate Ligament Injuries in Young Female Athletes: A Systematic Review and Meta-analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The influence of age on the effectiveness of neuromuscular training to reduce anterior cruciate ligament injury in female athletes: a meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular control training programs and noncontact anterior cruciate ligament injury rates in female athletes: a numbers-needed-to-treat analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a neuromuscular training program using external focus attention cues in male athletes with anterior cruciate ligament reconstruction: a randomized clinical trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Neuromuscular Training Based on the Neuromuscular Risk Profile. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preventive Neuromuscular Training for Young Female Athletes: Comparison of Coach and Athlete Compliance Rates. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Interventions designed to prevent anterior cruciate ligament injuries in adolescents and adults: a systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Training Improves Self-Reported Function and Single-Leg Landing Hip Biomechanics in Athletes After Anterior Cruciate Ligament Reconstruction. [2022]