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Not Applicable

Neuromuscular Rehabilitation for ACL Injury Prevention in Athletes

N/A
Recruiting
Led By Nathaniel Bates, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No low back or lower extremity injury in the year prior to ACL injury necessitating medical care
Age, 13 to 30 years
Must not have
Mechanisms of injury involved a direct blow of force to the knee
Patients with MCL injury that exhibits unresolved medial knee instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all 5 years of study
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking to see if they can reduce the risk of second ACL injury in athletes by identifying risk groups and giving them different rehabilitation protocols.

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects are not listed for this type of intervention, participants may experience general discomfort, muscle soreness, fatigue from exercises or potential aggravation of knee symptoms during rehabilitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had a lower back or leg injury requiring medical care in the year before my ACL injury.
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I am between 13 and 30 years old.
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I have a recent (less than 6 months) first-time ACL injury.
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I have never had knee surgery on either leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I injured my knee from a direct hit.
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My knee is unstable due to an untreated MCL injury.
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I have had knee surgery on either leg.
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I had a lower back or leg injury that needed medical attention before my ACL injury.
Select...
I do not have complex meniscus tears or full thickness cartilage lesions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all 5 years of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and all 5 years of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Second ACL Injury
Secondary study objectives
Frontal plane knee kinematics
Frontal plane knee kinetics

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TNMTExperimental Treatment1 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: HOMEExperimental Treatment1 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: STANActive Control1 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.

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,362 Total Patients Enrolled
1 Trials studying Rehabilitation
88 Patients Enrolled for Rehabilitation
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,199 Total Patients Enrolled
1 Trials studying Rehabilitation
1 Patients Enrolled for Rehabilitation
Nathaniel Bates, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
196 Total Patients Enrolled

Media Library

Neuromuscular Intervention (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT03190889 — N/A
Rehabilitation Research Study Groups: HOME, STAN, TNMT
Rehabilitation Clinical Trial 2023: Neuromuscular Intervention Highlights & Side Effects. Trial Name: NCT03190889 — N/A
Neuromuscular Intervention (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03190889 — N/A
~14 spots leftby Aug 2025