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
About this trial
This is an interventional prevention trial for Anterior Cruciate Ligament Rupture
Eligibility Criteria
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
NCT ID
NCT00140270
First Posted
August 30, 2005
Last Updated
August 30, 2005
Sponsor
Centers for Disease Control and Prevention
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
We'll reach out to this number within 24 hrs