- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080402
Mechanical Perturbation Training for ACL Injury Prevention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anterior cruciate ligament (ACL) injuries are prevalent in sports with female athletes at particularly high risk. Female athletes have 2-4x higher risk of ACL injury compared to their male counterparts in the same high-risk sports. Modifiable and non-modifiable risk factors play a role in the high incidence of ACL injuries in female athletes. High knee abduction moment (KAM), is a known modifiable risk factor for ACL injury risk. Female athletes with a KAM greater than 25.25 Nm have been identified as at high risk for an ACL injury. The ability to classify female athletes who are at a high risk for an ACL injury, highlights the importance of identifying modifiable risk factors that can be readily addressed by physical therapists and developing targeted treatments to potentially reduce ACL injury risk while improving functional performance.
Neuromuscular training programs are treatments designed to help improve coordination, strength, and control. Such training programs have been designed to alter biomechanical and neuromuscular measures, in particular high KAM, in order to improve performance and function and thereby reduce the risk of ACL injury. Neuromuscular training programs involving plyometric exercises can reduce dynamic lower extremity valgus and limb-to-limb asymmetries in healthy female athletes. Despite the reductions in injury rates seen with performance of neuromuscular training programs, incidence of ACL injuries is remains higher than acceptable. Novel training methods are currently in development to optimize these current ACL injury prevention programs. As unanticipated perturbations may contribute to ACL injury risk, incorporating a mechanical platform device that provides unanticipated surface compliance changes (i.e. the floor lowering down below a subject's feet) into an ACL injury prevention program has the potential to optimize knee biomechanics and neuromuscular performance, including during unanticipated perturbations.
Mechanical perturbation has been advocated for as an effective training method to modify the sensorimotor system and restore normal neuromuscular coordination through exposing the subjects to controlled, progressive perturbations. Furthermore, mechanical perturbation has the potential to improve dynamic postural stability and control, and enhance muscle activation patterns. One advantage of mechanical perturbation devices is that they can be utilized while performing a variety of dynamic tasks such as hopping and jumping compared to static loading tasks such as standing and balancing activities. Dynamic tasks may place a greater demand on the knee joint, promoting joint stability as the subject overcomes the perturbation. Additionally, mechanical perturbation may allow physical therapists to administer random perturbations at different phases of the activities (i.e. as the subject is landing from a hop, or taking-off from a jump) that simulate real-life perturbations which occur during different functional or sporting activities.
The goal of this study is to assess the effectiveness of an intensive neuromuscular training program to reduce risk factors associated with ACL injury
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martha Callahan
- Phone Number: (302) 831-6202
- Email: mcall@udel.edu
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19716
- Recruiting
- University of Delaware, Physical Therapy Department
-
Contact:
- Martha Callahan
- Phone Number: 302-831-6202
- Email: mcall@udel.edu
-
Principal Investigator:
- Lynn Snyder-Mackler, PT ATC ScD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female athletes will be eligible if they are: 1) regular participants in Level 1 and 2 sports (cutting and pivoting type sports, and 2) ages 15-30 years
Exclusion Criteria:
- History of major injury or surgery to the legs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High KAM
Mechanically-driven neuromuscular training.
2 times per week for 6 weeks for a total of 12 sessions.
Perturbation training
|
The training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing.
The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane.
The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks.
The final four sessions will incorporate rotational and pivoting activities with the maneuvers.
The resultant protocol has been derived and optimized from previous published research studies and prevention techniques.
Other Names:
|
No Intervention: Normal KAM
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak knee abduction moment
Time Frame: baseline and 6 weeks after baseline testing
|
Peak knee abduction moment during a drop jump landing task as assessed via motion analysis
|
baseline and 6 weeks after baseline testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Quadriceps torque 60 degrees/sec
Time Frame: baseline and 6 weeks after baseline testing
|
Peak Quadriceps torque 60 degrees/sec
|
baseline and 6 weeks after baseline testing
|
Peak Quadriceps torque 240 degrees/sec
Time Frame: baseline and 6 weeks after baseline testing
|
Peak Quadriceps torque 240 degrees/sec
|
baseline and 6 weeks after baseline testing
|
Peak Hamstrings torque 60 degrees/sec
Time Frame: baseline and 6 weeks after baseline testing
|
Peak Hamstrings torque 60 degrees/sec
|
baseline and 6 weeks after baseline testing
|
Peak Hamstrings torque 240 degrees/sec
Time Frame: baseline and 6 weeks after baseline testing
|
Peak Hamstrings torque 240 degrees/sec
|
baseline and 6 weeks after baseline testing
|
Single hop for distance LSI
Time Frame: baseline and 6 weeks after baseline testing
|
Single hop for distance limb symmetry index
|
baseline and 6 weeks after baseline testing
|
Crossover hop for distance LSI
Time Frame: baseline and 6 weeks after baseline testing
|
Crossover hop for distance limb symmetry index
|
baseline and 6 weeks after baseline testing
|
Triple hop for distance LSI
Time Frame: baseline and 6 weeks after baseline testing
|
Triple hop for distance limb symmetry index
|
baseline and 6 weeks after baseline testing
|
6m Timed Hop LSI
Time Frame: baseline and 6 weeks after baseline testing
|
6 meter Timed Hop limb symmetry index
|
baseline and 6 weeks after baseline testing
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical Jump
Time Frame: baseline and 6 weeks after baseline testing
|
Vertical jump for height
|
baseline and 6 weeks after baseline testing
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Snyder-Mackler, PT, ATC, ScD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44HD068054 (U.S. NIH Grant/Contract)
- 5R44HD068054 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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