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NCT Number: NCT02933008

Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality

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.

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Key information

Conditions

Injury of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory Healthcare Sports Performance And Research Center (SPARC), Flowery Branch, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aNMT Biofeedback

Other

aNMT utilizes well-established visual feedback strategies to promote efficient, rapid and robust learning of complex movements. Athletes can discover how to move to create the desired feedback, even without explicit, conscious knowledge of how their movements relate to the visual pattern. aNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine real-time transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create ("animate") a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention.

Sham Biofeedback

Other

Sham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases.

Neuromuscular Training

Other

Participants will complete a 12-session, pre-season training program, over 6 weeks.

Primary outcomes

  1. Change in Lateral Trunk Flexion

    Time frame: Baseline (pre-training testing), Week 6 (post-training testing)

    Lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.

  2. Change in Knee to Hip Sagittal Plane Moment Ratio

    Time frame: Baseline (pre-training testing), Week 6 (post-training testing)

    Knee to hip sagittal plane moment ratio during the vertical drop task will be compared between study arms. Optimal knee to hip sagittal plane ratio is < 1.

  3. Change in Knee Abduction Moment

    Time frame: Baseline (pre-training testing), Week 6 (post-training testing)

    Knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).

  4. Change in Foot Placement

    Time frame: Baseline (pre-training testing), Week 6 (post-training testing)

    Foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.

  5. Change in Vertical Ground Reaction Force (VGRF) Ratio

    Time frame: Baseline (pre-training testing), Week 6 (post-training testing)

    VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.

Secondary outcomes

  1. Change in Post-training Lateral Trunk Flexion

    Time frame: Week 6 (post-training testing), up to Month 11 (post-season testing)

    Retention of effects of the intervention is assessed with lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.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.

  2. Change in Post-training Knee to Hip Sagittal Plane Moment Ratio

    Time frame: Week 6 (post-training testing), up to Month 11 (post-season testing)

    Retention of effects of the intervention is assessed with knee to hip sagittal plane moment ratio during the vertical drop task will be compared between study arms. Optimal knee to hip sagittal plane ratio is < 1.

  3. Change in Post-training Knee Abduction Moment

    Time frame: Week 6 (post-training testing), up to Month 11 (post-season testing)

    Retention of effects of the intervention is assessed with knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).

  4. Change in Post-training Foot Placement

    Time frame: Week 6 (post-training testing), up to Month 11 (post-season testing)

    Retention of effects of the intervention is assessed with foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.

  5. Change in Post-training Vertical Ground Reaction Force (VGRF) Ratio

    Time frame: Week 6 (post-training testing), up to Month 11 (post-season testing)

    Retention of effects of the intervention is assessed with VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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