Mechanical Perturbation Training for ACL Injury Prevention

March 9, 2017 updated by: Lynn Snyder-Mackler, University of Delaware
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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
        • Principal Investigator:
          • Lynn Snyder-Mackler, PT ATC ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Reactive Agility Platform Trainer 2.0
  • RAPTr
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynn Snyder-Mackler, PT, ATC, ScD, University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

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)?

No

IPD Plan Description

There is currently no IPD sharing plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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