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Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality (MaNMT)

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ClinicalTrials.gov Identifier: NCT04068701
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Even though females are 2- to 10-times more likely to suffer an anterior cruciate ligament (ACL) injury, males represent the largest population of total ACL injuries. Consequently, there is a larger population of males that endure significant pain, functional limitations, and radiographic signs of knee osteoarthritis (OA) within 12 to 20 years of 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 investiagator's long-term goal is to reduce ACL injuries and the subsequent sequela in young male athletes.

Condition or disease Intervention/treatment Phase
ACL Injury Other: MaNMT Biofeedback Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Randomization and double blind
Primary Purpose: Prevention
Official Title: Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Experimental: MaNMT Biofeedback
A group that will receive a neuromuscular training intervention that incorporates biofeedback training
Other: MaNMT Biofeedback
neuromuscular training intervention that incorporates biofeedback training

Sham Comparator: Sham
a group that will receive the same neuromuscular training intervention with sham feedback training.
Other: MaNMT Biofeedback
neuromuscular training intervention that incorporates biofeedback training




Primary Outcome Measures :
  1. Change in knee flexion measured using motion analysis system [ Time Frame: 6 years ]
    measurement of knee flexion pre and post intervention to determine any change


Secondary Outcome Measures :
  1. Change in knee abduction moment measured using motion analysis system [ Time Frame: 6 years ]
    measurement of knee abduction moment pre and post intervention to determine any change



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   study is limited to male subjects
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: actively participate on the soccer, voleyball, or basketball team

Exclusion Criteria: do not participate on the soccer, voleyball, or basketball team


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068701


Contacts
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Contact: Kim D Barber Foss, MS 5136365971 kim.foss@cchmc.org
Contact: Staci Thomas, MS 513-803-1636 Staci.Thomas@cchmc.org

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Gregory D Myer, PhD Cincinnati Childrens Hospital
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04068701    
Other Study ID Numbers: 2019-0769
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
ACL
Biofeedback
Injury Prevention
Virtual Reality
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries