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

Primary Purpose

ACL Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MaNMT Biofeedback
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ACL Injury focused on measuring ACL, Biofeedback, Injury Prevention, Virtual Reality

Eligibility Criteria

12 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    MaNMT Biofeedback

    Sham

    Arm Description

    A group that will receive a neuromuscular training intervention that incorporates biofeedback training

    a group that will receive the same neuromuscular training intervention with sham feedback training.

    Outcomes

    Primary Outcome Measures

    Change in knee flexion measured using motion analysis system
    measurement of knee flexion pre and post intervention to determine any change

    Secondary Outcome Measures

    Change in knee abduction moment measured using motion analysis system
    measurement of knee abduction moment pre and post intervention to determine any change

    Full Information

    First Posted
    May 24, 2019
    Last Updated
    January 26, 2021
    Sponsor
    Children's Hospital Medical Center, Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04068701
    Brief Title
    Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
    Acronym
    MaNMT
    Official Title
    Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital Medical Center, Cincinnati

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Injury
    Keywords
    ACL, Biofeedback, Injury Prevention, Virtual Reality

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Randomization and double blind
    Allocation
    Randomized
    Enrollment
    380 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MaNMT Biofeedback
    Arm Type
    Experimental
    Arm Description
    A group that will receive a neuromuscular training intervention that incorporates biofeedback training
    Arm Title
    Sham
    Arm Type
    Sham Comparator
    Arm Description
    a group that will receive the same neuromuscular training intervention with sham feedback training.
    Intervention Type
    Other
    Intervention Name(s)
    MaNMT Biofeedback
    Intervention Description
    neuromuscular training intervention that incorporates biofeedback training
    Primary Outcome Measure Information:
    Title
    Change in knee flexion measured using motion analysis system
    Description
    measurement of knee flexion pre and post intervention to determine any change
    Time Frame
    6 years
    Secondary Outcome Measure Information:
    Title
    Change in knee abduction moment measured using motion analysis system
    Description
    measurement of knee abduction moment pre and post intervention to determine any change
    Time Frame
    6 years

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    study is limited to male subjects
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: actively participate on the soccer, voleyball, or basketball team Exclusion Criteria: do not participate on the soccer, voleyball, or basketball team
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kim D Barber Foss, MS
    Phone
    5136365971
    Email
    kim.foss@cchmc.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Staci Thomas, MS
    Phone
    513-803-1636
    Email
    Staci.Thomas@cchmc.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory D Myer, PhD
    Organizational Affiliation
    Cincinnati Childrens Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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