Clinical trial NCT03080402: Mechanical Perturbation Training for ACL Injury Prevention
Official title: Mechanical Perturbation Training for ACL Injury Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
ACL
Keywords: Anterior Cruciate Ligament
ACL injury
Injury prevention
Perturbation training
Risk factors
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Simbex, LLC
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-03-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Peak knee abduction moment
timeFrame: baseline and 6 weeks after baseline testing
Secondary outcomes:
measure: Peak Quadriceps torque 60 degrees/sec
timeFrame: baseline and 6 weeks after baseline testing
measure: Peak Quadriceps torque 240 degrees/sec
timeFrame: baseline and 6 weeks after baseline testing
measure: Peak Hamstrings torque 60 degrees/sec
timeFrame: baseline and 6 weeks after baseline testing
measure: Peak Hamstrings torque 240 degrees/sec
timeFrame: baseline and 6 weeks after baseline testing
measure: Single hop for distance LSI
timeFrame: baseline and 6 weeks after baseline testing
measure: Crossover hop for distance LSI
timeFrame: baseline and 6 weeks after baseline testing
measure: Triple hop for distance LSI
timeFrame: baseline and 6 weeks after baseline testing
measure: 6m Timed Hop LSI
timeFrame: baseline and 6 weeks after baseline testing
Other outcomes:
measure: Vertical Jump
timeFrame: baseline and 6 weeks after baseline testing
Locations:
city: Newark
country: United States
facility: University of Delaware, Physical Therapy Department
state: Delaware
Study officials:
affiliation: University of Delaware
name: Lynn Snyder-Mackler, PT, ATC, ScD
role: PRINCIPAL_INVESTIGATOR
References: