Clinical trial NCT02933008: Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality
Official title: Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Anterior Cruciate Ligament
Keywords: ACL
biofeedback
injury prevention
virtual reality
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-10-14
Enrollment: 420
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold greater rate in female than male athletes. Consequently, there is a larger population of females that endure significant pain, functional limitations, and radiographic signs of knee osteoarthritis (OA) within 12 to 20 years following injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence-based prevention of ACL injury. Specialized training that targets modifiable risk factors shows statistical efficacy in high-risk athletes; however, clinically meaningful reduction of risk has not been achieved. A critical barrier that limits successful training outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently deliver objective, effective feedback during training for injury prevention. The investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young female athletes. The overall objective of this proposal is to implement and test innovative augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal is that, after completion, the investigators will be equipped to more effectively deliver biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This contribution will be significant for the reduction of the long-term sequel following ACL injury in young females.

Detailed description: Augmented neuromuscular training (aNMT) integrates biomechanical screening with state-of-the-art augmented reality headsets to display real-time feedback that maps complex biomechanical variables onto simple visual feedback stimuli that athletes "control" via their own movements. The central hypothesis is that aNMT biofeedback will improve joint mechanics in evidence-based measures collected in realistic, sport-specific virtual reality scenarios. Specifically, the purpose of this investigation is to determine the efficacy of aNMT biofeedback to improve high-risk landing mechanics both in a laboratory task and during sport-specific scenarios. Based on the investigator's preliminary data, the investigators hypothesize that aNMT biofeedback will produce greater improvements in localized joint mechanics compared to neuromuscular training that incorporates sham feedback during the drop vertical jump (DVJ) task. In the secondary Aim, the investigators hypothesize aNMT will produce improved localized joint mechanics and global injury risk techniques during sport-specific maneuvers assessed in immersive virtual environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training. The positive impact will be the improvement of injury risk mechanics and the potential to reduce injury on the field of play. A randomized, repeated-measures design will be used to test the two hypotheses for Aim 1: First, that aNMT will produce greater improvements in localized joint mechanics compared to the sham feedback group during the DVJ task; second, based on the preliminary data the investigators expect that innovative aNMT will lead to graduated joint improvements and reduced global injury risk mechanics that will exceed the overall task transferred reductions in high risk biomechanics following 12 real-time biofeedback training sessions. Previously described techniques will be used to measure biomechanical risk factors during a DVJ task performed at the beginning and end of the 6-week pre-competition training period. Athletes will be randomized into one of two groups: 1) aNMT biofeedback or (2) sham (augmented reality glasses with a stimulus that will provide exercise repetition count). Each athlete, as well as the statisticians, will be blinded to the intervention. All athletes will receive 12 training sessions over a 6-week period during their pre-competition season and each of the groups will have longitudinal assessment of biomechanical outcome measures captured at each biofeedback session. All participants will complete pre-training testing, 6 weeks of intervention, post-training testing, and post-season testing.

Eligibility criteria: Inclusion Criteria:

* intend to participate on an organized competitive sports team (volleyball, soccer, or basketball)
* be physically able to participate in their sport and complete the testing procedures at the time of study enrollment

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in Lateral Trunk Flexion
timeFrame: Baseline (pre-training testing), Week 6 (post-training testing)
measure: Change in Knee to Hip Sagittal Plane Moment Ratio
timeFrame: Baseline (pre-training testing), Week 6 (post-training testing)
measure: Change in Knee Abduction Moment
timeFrame: Baseline (pre-training testing), Week 6 (post-training testing)
measure: Change in Foot Placement
timeFrame: Baseline (pre-training testing), Week 6 (post-training testing)
measure: Change in Vertical Ground Reaction Force (VGRF) Ratio
timeFrame: Baseline (pre-training testing), Week 6 (post-training testing)
Secondary outcomes:
measure: Change in Post-training Lateral Trunk Flexion
timeFrame: Week 6 (post-training testing), up to Month 11 (post-season testing)
measure: Change in Post-training Knee to Hip Sagittal Plane Moment Ratio
timeFrame: Week 6 (post-training testing), up to Month 11 (post-season testing)
measure: Change in Post-training Knee Abduction Moment
timeFrame: Week 6 (post-training testing), up to Month 11 (post-season testing)
measure: Change in Post-training Foot Placement
timeFrame: Week 6 (post-training testing), up to Month 11 (post-season testing)
measure: Change in Post-training Vertical Ground Reaction Force (VGRF) Ratio
timeFrame: Week 6 (post-training testing), up to Month 11 (post-season testing)
Other outcomes:
Locations:
city: Flowery Branch
country: United States
facility: Emory Healthcare Sports Performance And Research Center (SPARC)
state: Georgia
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Emory University
name: Gregory D Myer, PhD
role: PRINCIPAL_INVESTIGATOR
References: