Mechanical Perturbation Training for ACL Injury Prevention
Primary Purpose
Anterior Cruciate Ligament Injury, ACL
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mechanical Perturbation Training
Sponsored by
About this trial
This is an interventional prevention trial for Anterior Cruciate Ligament Injury focused on measuring Anterior Cruciate Ligament, ACL injury, Injury prevention, Perturbation training, Risk factors
Eligibility Criteria
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.
Sites / Locations
- University of Delaware, Physical Therapy DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High KAM
Normal KAM
Arm Description
Mechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training
No intervention
Outcomes
Primary Outcome Measures
Peak knee abduction moment
Peak knee abduction moment during a drop jump landing task as assessed via motion analysis
Secondary Outcome Measures
Peak Quadriceps torque 60 degrees/sec
Peak Quadriceps torque 60 degrees/sec
Peak Quadriceps torque 240 degrees/sec
Peak Quadriceps torque 240 degrees/sec
Peak Hamstrings torque 60 degrees/sec
Peak Hamstrings torque 60 degrees/sec
Peak Hamstrings torque 240 degrees/sec
Peak Hamstrings torque 240 degrees/sec
Single hop for distance LSI
Single hop for distance limb symmetry index
Crossover hop for distance LSI
Crossover hop for distance limb symmetry index
Triple hop for distance LSI
Triple hop for distance limb symmetry index
6m Timed Hop LSI
6 meter Timed Hop limb symmetry index
Full Information
NCT ID
NCT03080402
First Posted
March 9, 2017
Last Updated
March 9, 2017
Sponsor
University of Delaware
Collaborators
Simbex, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03080402
Brief Title
Mechanical Perturbation Training for ACL Injury Prevention
Official Title
Mechanical Perturbation Training for ACL Injury Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
Simbex, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Using a prospective risk stratification design, female athletes with knee abduction moment (KAM) > 25.25 Nm from drop jump motion analysis will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM < 25.25 Nm from drop jump motion analysis will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, ACL
Keywords
Anterior Cruciate Ligament, ACL injury, Injury prevention, Perturbation training, Risk factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
24 female athletes (12 with high KAM; 12 with normal KAM) will be recruited into the intervention/ testing phase of this study. Female athletes with KAM > 25.25 Nm will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM < 25.25 Nm will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High KAM
Arm Type
Experimental
Arm Description
Mechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training
Arm Title
Normal KAM
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
Mechanical Perturbation Training
Other Intervention Name(s)
Reactive Agility Platform Trainer 2.0, RAPTr
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak knee abduction moment
Description
Peak knee abduction moment during a drop jump landing task as assessed via motion analysis
Time Frame
baseline and 6 weeks after baseline testing
Secondary Outcome Measure Information:
Title
Peak Quadriceps torque 60 degrees/sec
Description
Peak Quadriceps torque 60 degrees/sec
Time Frame
baseline and 6 weeks after baseline testing
Title
Peak Quadriceps torque 240 degrees/sec
Description
Peak Quadriceps torque 240 degrees/sec
Time Frame
baseline and 6 weeks after baseline testing
Title
Peak Hamstrings torque 60 degrees/sec
Description
Peak Hamstrings torque 60 degrees/sec
Time Frame
baseline and 6 weeks after baseline testing
Title
Peak Hamstrings torque 240 degrees/sec
Description
Peak Hamstrings torque 240 degrees/sec
Time Frame
baseline and 6 weeks after baseline testing
Title
Single hop for distance LSI
Description
Single hop for distance limb symmetry index
Time Frame
baseline and 6 weeks after baseline testing
Title
Crossover hop for distance LSI
Description
Crossover hop for distance limb symmetry index
Time Frame
baseline and 6 weeks after baseline testing
Title
Triple hop for distance LSI
Description
Triple hop for distance limb symmetry index
Time Frame
baseline and 6 weeks after baseline testing
Title
6m Timed Hop LSI
Description
6 meter Timed Hop limb symmetry index
Time Frame
baseline and 6 weeks after baseline testing
Other Pre-specified Outcome Measures:
Title
Vertical Jump
Description
Vertical jump for height
Time Frame
baseline and 6 weeks after baseline testing
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Callahan
Phone
(302) 831-6202
Email
mcall@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Snyder-Mackler, PT, ATC, ScD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware, Physical Therapy Department
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Callahan
Phone
302-831-6202
Email
mcall@udel.edu
First Name & Middle Initial & Last Name & Degree
Lynn Snyder-Mackler, PT ATC ScD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no IPD sharing plan.
Learn more about this trial
Mechanical Perturbation Training for ACL Injury Prevention
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