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Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST)

Primary Purpose

Knee Injuries

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Neuromuscular Training
Hip Focused ROBUST Training
Knee Focused ROBUST Training
Sponsored by
High Point University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Injuries focused on measuring Anterior Cruciate Ligament

Eligibility Criteria

9 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Currently participating on club or school sponsored soccer team

Exclusion Criteria:

  • Current injury that limits participating in sport
  • Male
  • Cannot participate in a 6-week intervention due to time or other constraints

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Biofeedback Hip

    Biofeedback Knee

    Neuromuscular Training

    Arm Description

    Hip focused biofeedback with neuromuscular training

    Knee focused biofeedback with neuromuscular training

    Neuromuscular Training component

    Outcomes

    Primary Outcome Measures

    Knee abduction load
    Knee abduction load will be the primary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks immediately before and after 6 weeks of the study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.

    Secondary Outcome Measures

    Knee abduction load
    Knee abduction load following a 6 month retention time will be the secondary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks following 6 months after study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.

    Full Information

    First Posted
    April 20, 2016
    Last Updated
    February 20, 2019
    Sponsor
    High Point University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02754700
    Brief Title
    Real-time Optimized Biofeedback Utilizing Sport Techniques
    Acronym
    ROBUST
    Official Title
    Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    February 1, 2019 (Actual)
    Study Completion Date
    February 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    High Point University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. The investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. A six-month follow-up design will be used to test retention of real-time biofeedback intervention.
    Detailed Description
    Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) represents an innovative new approach to reduce traumatic anterior cruciate ligament (ACL) injuries. Over the last four decades, these debilitating injuries have occurred at a 2 to 10-fold greater rate in female compared to male athletes with the highest prevalence occurring between the ages of 16-18 years. As a consequence, there is a large population of females that endure significant pain, functional limitations and knee osteoarthritis (OA) as early as 5 years after the initial unintentional injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends both expanding and refining evidence-based prevention of ACL injury. There currently is a gap in knowledge regarding how to maximize the effectiveness of injury prevention training in young female athletes. The long-term goal is to reduce ACL injuries in young female athletes. The objective of this application is to increase the efficacy of biofeedback training to reduce the risk of ACL injury. This proposal tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions. The rationale supporting this proposal is that once the proposed research is completed, health professionals will be more successful at preventing devastating ACL injuries through properly optimized and targeted biofeedback training for young at-risk females. This research is innovative because it represents a new and substantive departure from the status quo by recognizing the need to optimize the application of biofeedback training. The work will contribute clinically relevant data in support of a future more robust clinical trial. The proposed research will be significant because it will lead to reduced rates of ACL injury in young females. Reduction of female injury rates to equal that of males would allow females annually to continue the health benefits of sports participation and avoid the long-term complications of osteoarthritis, which occurs with a 10 to 100-fold greater incidence in ACL-injured than in uninjured athletes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Injuries
    Keywords
    Anterior Cruciate Ligament

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Biofeedback Hip
    Arm Type
    Experimental
    Arm Description
    Hip focused biofeedback with neuromuscular training
    Arm Title
    Biofeedback Knee
    Arm Type
    Experimental
    Arm Description
    Knee focused biofeedback with neuromuscular training
    Arm Title
    Neuromuscular Training
    Arm Type
    Active Comparator
    Arm Description
    Neuromuscular Training component
    Intervention Type
    Other
    Intervention Name(s)
    Neuromuscular Training
    Intervention Description
    Standardized, comprehensive neuromuscular training
    Intervention Type
    Other
    Intervention Name(s)
    Hip Focused ROBUST Training
    Intervention Description
    Biofeedback training focused on the hip extensors
    Intervention Type
    Other
    Intervention Name(s)
    Knee Focused ROBUST Training
    Intervention Description
    Biofeedback training focused on knee abduction
    Primary Outcome Measure Information:
    Title
    Knee abduction load
    Description
    Knee abduction load will be the primary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks immediately before and after 6 weeks of the study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Knee abduction load
    Description
    Knee abduction load following a 6 month retention time will be the secondary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks following 6 months after study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Currently participating on club or school sponsored soccer team Exclusion Criteria: Current injury that limits participating in sport Male Cannot participate in a 6-week intervention due to time or other constraints
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Ford, PhD
    Organizational Affiliation
    High Point University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28173788
    Citation
    Taylor JB, Nguyen AD, Paterno MV, Huang B, Ford KR. Real-time optimized biofeedback utilizing sport techniques (ROBUST): a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 7;18(1):71. doi: 10.1186/s12891-017-1436-1.
    Results Reference
    derived

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