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RCT of PEP Program to Reduce ACL Injuries in Female Collegiate Soccer Players

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PEP program
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female soccer athlete on participating Division I women's soccer team Exclusion Criteria: none

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ligamentous knee and ankle injuries;
    specific interest is the ACL

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2005
    Last Updated
    August 30, 2005
    Sponsor
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00140270
    Brief Title
    RCT of PEP Program to Reduce ACL Injuries in Female Collegiate Soccer Players
    Official Title
    Evaluating the Effectiveness of a Neuromuscular and Proprioceptive Training Program to Reduce Ligamentous Knee Injuries Among Female Collegiate Soccer Players.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centers for Disease Control and Prevention

    4. Oversight

    5. Study Description

    Brief Summary
    This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.
    Detailed Description
    This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    PEP program
    Primary Outcome Measure Information:
    Title
    Ligamentous knee and ankle injuries;
    Title
    specific interest is the ACL

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female soccer athlete on participating Division I women's soccer team Exclusion Criteria: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Gilchrist, MD
    Organizational Affiliation
    Centers for Disease Control and Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.aclprevent.com/
    Description
    site has description of the intervention under study

    Learn more about this trial

    RCT of PEP Program to Reduce ACL Injuries in Female Collegiate Soccer Players

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