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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 belowSelect...
I haven't had a lower back or leg injury requiring medical care in the year before my ACL injury.
Select...
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:Select...
I injured my knee from a direct hit.
Select...
My knee is unstable due to an untreated MCL injury.
Select...
I have had knee surgery on either leg.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ all 5 years of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all 5 years of study
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
502 Previous Clinical Trials
1,089,868 Total Patients Enrolled
1 Trials studying Rehabilitation
88 Patients Enrolled for Rehabilitation
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,856 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
Aaron Krych, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
245 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a lower back or leg injury requiring medical care in the year before my ACL injury.My knee is stable after an MCL injury and before surgery.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.I am between 13 and 30 years old.I have a recent (less than 6 months) first-time ACL injury.I have never had knee surgery on either leg.I have had knee surgery on either leg.I had a lower back or leg injury that needed medical attention before my ACL injury.I do not have complex meniscus tears or full thickness cartilage lesions.I have a simple meniscus tear that doesn't require special rehab changes.
Research Study Groups:
This trial has the following groups:- Group 1: HOME
- Group 2: STAN
- Group 3: TNMT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.