RehabilitationNCT03190889
Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
A study testing HOME and TNMT in people with Rehabilitation and ACL Reconstruction, run by Mayo Clinic at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Rehabilitation, ACL Reconstruction
- What is being tested?
- HOME and TNMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Emory University
Flowery Branch, Georgia, 30542
Mayo Clinic Square
Minneapolis, Minnesota, 55403
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
Importance of the problem. Second ACL injury, whether it is an insult to the ipsilateral graft or the contralateral ligament, is a growing problem after reconstruction. Besides missing an additional year of athletic participation, increasing health care costs, and increased psychological distress, re-injury and subsequent revision surgery have significantly worse outcomes compared with those after initial reconstruction. Second injuries have been reported to occur at a rate of 1 of 17 (6%) within the first two years of surgery. However, a second tear prevalence of 29% has been reported. This is substantially higher than initial ACL injuries, reported to occur at a rate of 1 in 60 to 100. Risk factors for second injury include younger athletes 6 who return to high-level sporting activities early. Both sexes are at risk for second ACL injury, with women reported as having higher risk of contralateral injury, and men having an increased risk of ipsilateral injury. Thus, it is critical to include both sexes in second ACL injury prevention programs.
Improvement in scientific knowledge and clinical practice: Patients have differential responses after ACL injury, including their functional abilities, movement biomechanics, neuromuscular performance, and quadriceps strength. Building from our prior funded work, the investigators propose to prospectively evaluate these varying patient characteristics in an attempt to identify distinct groups with differing levels of risk for second injury (Aim 1). Our previous work revealed that there were three risk groups among uninjured female athletes. The significance of identification of patient groups with distinct needs is profound. Prospective identification of at-risk patients who are the most appropriate recipients of enhanced treatment will likely reduce second ACL risk, and yield a more efficacious delivery of health care resources after ACLR. The Cincinnati group described this differentiation in ACL deficient patients as the 'rule of thirds,' with one third of patients able to function without limitations and not needing to undergo surgical stabilization, one third adapting their activity level without surgery, and one third requiring surgery to perform daily activities without knee instability. A classification scheme described by the University of Delaware also differentiates ACL deficient patients into groups of thirds including copers (no limit in abilities), non-copers (unable to function without knee instability) or potential copers (individuals who have the potential to function without ACLR). There is evidence these differences in functional abilities and movement characteristics persist after ACLR. A randomized clinical trial concluded individuals who exhibit poor knee stability and function after injury may require additional time to return to pre-injury functional levels. In addition, some may be unable to develop appropriate quadriceps strength symmetry to support a return to high-level sports. These data indicate not all patients experience the same magnitude or duration of impairments and symptoms after ACLR. Consequently, multiple post-operative rehabilitation strategies may be necessary to facilitate optimum patient care and outcomes.
Working from the rule of one-thirds, identification of distinct patient groups with unique needs after surgery is a novel approach for integration of optimum second injury prevention strategies. Primary-injury risk factors provide an important window into the underlying biomechanical and neuromuscular deficits that may persist after ACL injury and reconstruction. Using a statistical analysis clustering technique, distinct groups with relative risk for first-time ACL injury have been identified, including low, moderate and high risk groups. Single limb postural stability combined with biomechanical variables including vertical ground reaction force (vGRF), frontal plane hip adduction moment minimum, and pelvis angle during drop jump landings were identified as significant contributors to frontal plane knee loading, a surrogate for ACL injury risk. This work has demonstrated the existence of discernable groups of athletes that are more appropriate for targeted neuromuscular training (TNMT) intervention to prevent first-time ACL injury.
Factors that contribute to primary ACL injury risk provide an important window into the underlying deficits that may persist after ACL injury and reconstruction. Age and activity level are significant factors, as young active individuals are the most likely cohort to sustain a second ACL rupture. Surgical factors include decreased graft size, use of allograft tissue, vertical graft position, and a lax graft. Anatomical risk factors may also contribute to ACL injury risk and include an increase in the posterior-inferior lateral tibial plateau slope and decreased notch width. Genetic factors also likely play a role. While it is encouraging that so many potential factors have been identified which may contribute to second ACL injury risk, none of these factors can be modified through non-surgical intervention. Modifiable biomechanical and neuromuscular measures associated with second ACL injury have been identified. Previous work by our laboratory included a prospective clinical trial, athletes who had undergone ACLR underwent testing before a return to pivoting and cutting sports. Thirteen athletes sustained a subsequent injury. Specific injury predictive parameters identified during testing included a net internal rotation moment of the uninvolved hip, an increase in total frontal plane knee movement, greater asymmetry in internal knee extensor moment at initial contact, and deficits in single-leg postural stability of the involved limb. These parameters predicted second injury in this population with excellent sensitivity (0.92) and specificity (0.88).
Differences in functional abilities after ACLR may be differentiated by more than biomechanical and neuromuscular characteristics. Clinically measured muscle weakness may persist for years after ACLR. Quadriceps strength is strongly related to measurements of knee function in athletes who have undergone ACLR. While hamstrings strength alone may not show a significant effect on knee function following ACL injury and reconstruction, hamstrings activation may be an important component in neuromuscular control of the reconstructed knee, especially in females, who tend to be 'quadriceps dominant'. In addition, deficits in the hamstrings-quadriceps torque production ratio also appear to be a key variable in the primary ACL injury risk model. The relationship between muscle weakness and differential risk for second injury has not been established. An understanding of the interplay may, however, be critical to the development of effective, group-specific intervention programs and reduction of second-injury risk.
It is currently unknown if biomechanical and clinical measures may effectively discern groups of patients who are at greatest risk for second ACL injury. Evaluation of movement mechanics and clinical characteristics, including strength, limb stability and self-reported function, at the time a patient initiates sports-specific training may yield insight to differential responses after ACLR. If distinct patient groups are identified, this information may be used to provide differentiated interventions based on risk for second injury. In Aim 2 of this proposal, the investigators will evaluate the effects of differential rehabilitation interventions. Our Exploratory Aim will be the initial step in translating the biomechanics-based, group algorithm into a clinical application for individualized categorization of risk. The results of this work may instigate a paradigm shift in treatment, and promote a more efficacious utilization of healthcare resources by providing enhanced care to those patients who are at greatest risk for secondary injury.
Impact on patient care. One of the factors that contributes to second ACL injury is incomplete or ineffective rehabilitation. Aberrant neuromuscular and biomechanical patterns are commonly seen up to 2 years after ACLR and may help explain the high rate of second ACL injury. Deficits in the neuromuscular control of both lower extremities following ACLR have been directly implicated in the risk for second ACL injury and may not only be a result of the initial knee injury and subsequent surgery, but may also characterize the athlete's pre-injury movement patterns. Therefore, identification and subsequent targeted treatment of aberrant post-ACLR movement patterns for both limbs are critical not only to maximize functional recovery but also to reduce the risk for second ACL injury. Though neuromuscular training programs result in a 73.4% decreased risk of a non-contact primary-ACL injury compared to those who do not participate in neuromuscular training, the efficacy of similar programs for reduction of second-ACL injury risk has not been examined.
An evidence-based targeted neuromuscular training (TNMT) program has been designed to prevent second ACL injury. This training program was developed with consideration to modifiable factors related to second-injury risk, the principles of motor learning, and careful selection of the exercises that may most effectively modify aberrant neuromuscular programs. In Aims 2 and 3 of this competing renewal proposal the investigators will evaluate the effects of differential treatment interventions. Notably, the investigators will assess the effectiveness of TNMT, including the utilization of visual and verbal biofeedback. Validation of this evidence-based, late-phase TNMT program may significantly impact clinical practice patterns through its integration in rehabilitation settings, and serve as a critical factor in reduction of second injury risk. Ultimately, determining if less intensive HOME and STAN training programs are effective interventions for patients who are at reduced risk for second ACL injury may prove to be a tremendous time and cost savings for patients and the health-care system.
- Conditions
- Rehabilitation, ACL Reconstruction
- Being tested
- HOME, TNMT
- Keywords
- ACL Reconstruction, Rehabilitation, Sports Injury, Neuromuscular Intervention, Knee Injury
- Medical subject headings
- Athletic Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMEOther
At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.
TNMTOther
Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TNMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-48 months
Secondary outcomes (2)
Frontal Plane Knee Kinetics
Joint moments at the knee will be recorded from study participants as they perform athletic tasks. Frontal plane knee moments have previously been associated with ACL injury risk and will be used to assess the proposed treatment groups.
Measured: Change after 6 weeks of interventional protocol
Frontal Plane Knee Kinematics
Joint excursion and angles at the knee will be recorded from study participants as they perform athletic tasks. Frontal plane excursion and angle has been associated with increased frontal plane moments that are associated with increased relative risk of ACL injury.
Measured: Change after 6 weeks of interventional protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Aug 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Aaron Krych, Mayo Clinic
- Investigators
- Aaron J Krych, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190889
- Sponsor's protocol ID
- 17-001833
- Other IDs
- R01AR055563
- Status last verified
- Feb 2026
- First submitted
- 15 May 2017
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
- ClinicalTrials.gov ID
- NCT03190889
- Acronym / sponsor ID
- 17-001833
- Conditions
- Rehabilitation, ACL Reconstruction
- Keywords
- ACL Reconstruction, Rehabilitation, Sports Injury, Neuromuscular Intervention, Knee Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Importance of the problem. Second ACL injury, whether it is an insult to the ipsilateral graft or the contralateral ligament, is a growing problem after reconstruction. Besides missing an additional year of athletic participation, increasing health care costs, and increased psychological distress, re-injury and subsequent revision surgery have significantly worse outcomes compared with those after initial reconstruction. Second injuries have been reported to occur at a rate of 1 of 17 (6%) within the first two years of surgery. However, a second tear prevalence of 29% has been reported. This is substantially higher than initial ACL injuries, reported to occur at a rate of 1 in 60 to 100. Risk factors for second injury include younger athletes 6 who return to high-level sporting activities early. Both sexes are at risk for second ACL injury, with women reported as having higher risk of contralateral injury, and men having an increased risk of ipsilateral injury. Thus, it is critical to include both sexes in second ACL injury prevention programs.
Improvement in scientific knowledge and clinical practice: Patients have differential responses after ACL injury, including their functional abilities, movement biomechanics, neuromuscular performance, and quadriceps strength. Building from our prior funded work, the investigators propose to prospectively evaluate these varying patient characteristics in an attempt to identify distinct groups with differing levels of risk for second injury (Aim 1). Our previous work revealed that there were three risk groups among uninjured female athletes. The significance of identification of patient groups with distinct needs is profound. Prospective identification of at-risk patients who are the most appropriate recipients of enhanced treatment will likely reduce second ACL risk, and yield a more efficacious delivery of health care resources after ACLR. The Cincinnati group described this differentiation in ACL deficient patients as the 'rule of thirds,' with one third of patients able to function without limitations and not needing to undergo surgical stabilization, one third adapting their activity level without surgery, and one third requiring surgery to perform daily activities without knee instability. A classification scheme described by the University of Delaware also differentiates ACL deficient patients into groups of thirds including copers (no limit in abilities), non-copers (unable to function without knee instability) or potential copers (individuals who have the potential to function without ACLR). There is evidence these differences in functional abilities and movement characteristics persist after ACLR. A randomized clinical trial concluded individuals who exhibit poor knee stability and function after injury may require additional time to return to pre-injury functional levels. In addition, some may be unable to develop appropriate quadriceps strength symmetry to support a return to high-level sports. These data indicate not all patients experience the same magnitude or duration of impairments and symptoms after ACLR. Consequently, multiple post-operative rehabilitation strategies may be necessary to facilitate optimum patient care and outcomes.
Working from the rule of one-thirds, identification of distinct patient groups with unique needs after surgery is a novel approach for integration of optimum second injury prevention strategies. Primary-injury risk factors provide an important window into the underlying biomechanical and neuromuscular deficits that may persist after ACL injury and reconstruction. Using a statistical analysis clustering technique, distinct groups with relative risk for first-time ACL injury have been identified, including low, moderate and high risk groups. Single limb postural stability combined with biomechanical variables including vertical ground reaction force (vGRF), frontal plane hip adduction moment minimum, and pelvis angle during drop jump landings were identified as significant contributors to frontal plane knee loading, a surrogate for ACL injury risk. This work has demonstrated the existence of discernable groups of athletes that are more appropriate for targeted neuromuscular training (TNMT) intervention to prevent first-time ACL injury.
Factors that contribute to primary ACL injury risk provide an important window into the underlying deficits that may persist after ACL injury and reconstruction. Age and activity level are significant factors, as young active individuals are the most likely cohort to sustain a second ACL rupture. Surgical factors include decreased graft size, use of allograft tissue, vertical graft position, and a lax graft. Anatomical risk factors may also contribute to ACL injury risk and include an increase in the posterior-inferior lateral tibial plateau slope and decreased notch width. Genetic factors also likely play a role. While it is encouraging that so many potential factors have been identified which may contribute to second ACL injury risk, none of these factors can be modified through non-surgical intervention. Modifiable biomechanical and neuromuscular measures associated with second ACL injury have been identified. Previous work by our laboratory included a prospective clinical trial, athletes who had undergone ACLR underwent testing before a return to pivoting and cutting sports. Thirteen athletes sustained a subsequent injury. Specific injury predictive parameters identified during testing included a net internal rotation moment of the uninvolved hip, an increase in total frontal plane knee movement, greater asymmetry in internal knee extensor moment at initial contact, and deficits in single-leg postural stability of the involved limb. These parameters predicted second injury in this population with excellent sensitivity (0.92) and specificity (0.88).
Differences in functional abilities after ACLR may be differentiated by more than biomechanical and neuromuscular characteristics. Clinically measured muscle weakness may persist for years after ACLR. Quadriceps strength is strongly related to measurements of knee function in athletes who have undergone ACLR. While hamstrings strength alone may not show a significant effect on knee function following ACL injury and reconstruction, hamstrings activation may be an important component in neuromuscular control of the reconstructed knee, especially in females, who tend to be 'quadriceps dominant'. In addition, deficits in the hamstrings-quadriceps torque production ratio also appear to be a key variable in the primary ACL injury risk model. The relationship between muscle weakness and differential risk for second injury has not been established. An understanding of the interplay may, however, be critical to the development of effective, group-specific intervention programs and reduction of second-injury risk.
It is currently unknown if biomechanical and clinical measures may effectively discern groups of patients who are at greatest risk for second ACL injury. Evaluation of movement mechanics and clinical characteristics, including strength, limb stability and self-reported function, at the time a patient initiates sports-specific training may yield insight to differential responses after ACLR. If distinct patient groups are identified, this information may be used to provide differentiated interventions based on risk for second injury. In Aim 2 of this proposal, the investigators will evaluate the effects of differential rehabilitation interventions. Our Exploratory Aim will be the initial step in translating the biomechanics-based, group algorithm into a clinical application for individualized categorization of risk. The results of this work may instigate a paradigm shift in treatment, and promote a more efficacious utilization of healthcare resources by providing enhanced care to those patients who are at greatest risk for secondary injury.
Impact on patient care. One of the factors that contributes to second ACL injury is incomplete or ineffective rehabilitation. Aberrant neuromuscular and biomechanical patterns are commonly seen up to 2 years after ACLR and may help explain the high rate of second ACL injury. Deficits in the neuromuscular control of both lower extremities following ACLR have been directly implicated in the risk for second ACL injury and may not only be a result of the initial knee injury and subsequent surgery, but may also characterize the athlete's pre-injury movement patterns. Therefore, identification and subsequent targeted treatment of aberrant post-ACLR movement patterns for both limbs are critical not only to maximize functional recovery but also to reduce the risk for second ACL injury. Though neuromuscular training programs result in a 73.4% decreased risk of a non-contact primary-ACL injury compared to those who do not participate in neuromuscular training, the efficacy of similar programs for reduction of second-ACL injury risk has not been examined.
An evidence-based targeted neuromuscular training (TNMT) program has been designed to prevent second ACL injury. This training program was developed with consideration to modifiable factors related to second-injury risk, the principles of motor learning, and careful selection of the exercises that may most effectively modify aberrant neuromuscular programs. In Aims 2 and 3 of this competing renewal proposal the investigators will evaluate the effects of differential treatment interventions. Notably, the investigators will assess the effectiveness of TNMT, including the utilization of visual and verbal biofeedback. Validation of this evidence-based, late-phase TNMT program may significantly impact clinical practice patterns through its integration in rehabilitation settings, and serve as a critical factor in reduction of second injury risk. Ultimately, determining if less intensive HOME and STAN training programs are effective interventions for patients who are at reduced risk for second ACL injury may prove to be a tremendous time and cost savings for patients and the health-care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: HOMEHOME 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. |
| Intervention Group with Neuromuscular Training | Experimental | Other: TNMTPatients 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. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| HOMEAt home rehabilitation following ACL reconstructive surgery as described in the HOME arm. | Other | Control Group |
| TNMTStandard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm. | Other | Intervention Group with Neuromuscular Training |
Primary outcome
Number of Participants With Second ACL Injury
Time frame: 12-48 months
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.
2 secondary outcomes
Frontal Plane Knee Kinetics
Time frame: Change after 6 weeks of interventional protocol
Frontal Plane Knee Kinematics
Time frame: Change after 6 weeks of interventional protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aaron J Krych, MD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME and TNMT in people with Rehabilitation and ACL Reconstruction, run by Mayo Clinic at 4 sites 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Second ACL Injury (time frame: 12-48 months). 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 11 Mar 2026.