Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes

NCT03190889 | Completed Results

• 2 other identifiers: 17-001833R01AR055563
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Rehabilitation; ACL Reconstruction

Keywords

ACL Reconstruction; Rehabilitation; Sports Injury; Neuromuscular Intervention; Knee Injury

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Second ACL Injury

  Subjects recruited for this investigation will be recovering from primary ACL injury. Participants will be monitored for injury history from time of enrollment in study. Report of any additional ACL injury whether contralateral leg or involved leg will be counted as a second ACL injury.

  12-48 months

Secondary Outcomes (2)

• Frontal Plane Knee Kinetics

  Change after 6 weeks of interventional protocol

• Frontal Plane Knee Kinematics

  Change after 6 weeks of interventional protocol

Study Arms (3)

Standard of Care Group

NO 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.

Control Group

OTHER

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.

Other: HOME

Intervention Group with Neuromuscular Training

EXPERIMENTAL

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.

Other: TNMT

Interventions

HOME OTHER

At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.

Control Group

TNMT OTHER

Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.

Intervention Group with Neuromuscular Training

Eligibility Criteria

• Age: 13 Years - 30 Years
• Gender Eligibility Details: Planned distribution of subjects: US census reports for 2014 indicate the female sex comprises approximately 50% of the population in Olmsted (Rochester, MN) county. We therefore anticipate women will comprise approximately half of the study population.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age, 13 ≥ 30 years
• Acute (\< 6 months), first-time, isolated ACL injury
• No history of previous knee surgery to either extremity
• No low back or lower extremity injury in the year prior to ACL injury necessitating medical care
• Pre-injury participation in cutting, jumping or pivoting sports for ≥ 50 hours/year
• Mechanism of injury did not involve a direct blow to the knee.
• Patients who sustain a medial collateral ligament (MCL) injury are eligible for study participation if medial knee instability is resolved prior to surgery
• Patients with simple meniscus tears (i.e., 2 cm vertical longitudinal tear) that do not necessitate alterations in rehabilitation will be eligible for study participation

You may not qualify if:

• History of previous knee surgery to either extremity
• Low back or lower extremity injury in the year prior to ACL injury necessitating medical care
• Second or greater ACL injury
• Greater than 6 months since occurrence of ACL injury
• Lack of participation in cutting, jumping, or pivoting sport
• Mechanisms of injury involved a direct blow of force to the knee
• Patients with MCL injury that exhibits unresolved medial knee instability
• Patients with complex, repairable meniscus tears (i.e., radial or root repair) and patients with full thickness articular cartilage lesions will not be eligible for participation secondary to significant alterations to postoperative rehabilitation protocol

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (4)

Emory University

Flowery Branch, Georgia, 30542, United States

Location

Mayo Clinic Square

Minneapolis, Minnesota, 55403, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Athletic Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Nathaniel A. Bates
• Organization: The Ohio State University Wexner Medical Center

nathaniel.bates@osumc.edu

614-293-9013

Study Officials

• Aaron J Krych, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects are masked from group assignment. Group assignment is randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Overall Strategy. This is a prospective, randomized, repeated measures single- blind clinical trial. The purposes of this study are to 1) stratify patient risk for second ACL injury, and 2) determine the effects of differential treatment intervention, including targeted neuromuscular training (TNMT), home program only (HOME) and standard clinical (STAN) training, on clinical, biomechanical, and neuromuscular performance measures associated with an increased ACL injury risk. After the initial ACL injury and study enrollment, all patients will participate in standardized pre-operative rehabilitation. They will then undergo surgery by a fellowship-trained sports medicine surgeon at Mayo Clinic, Rochester, MN. Data for Aim 1 will be obtained from biomechanical, neuromuscular and clinical testing performed during Pre-Testing. Data for Aim 2 and the Exploratory Aim will be obtained from biomechanical and clinical test results obtained from Pre- and Post-Testing time points.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: June 19, 2017
• Study Start: August 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 11, 2026
• Results First Posted: April 11, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)