- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04266925
Preventing Youth Soccer Injury
May 8, 2020 updated by: David Schwebel, University of Alabama at Birmingham
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer.
Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped.
The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB Youth Safety Lab, University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unit of measurement was youth soccer teams playing in Birmingham, Alabama area league
Exclusion Criteria:
- teams serving children under age 9 or over age 11
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3 referees
Three referees were present on the field during these youth soccer matches.
|
We compared player behavior with one versus three referees present on youth soccer fields during match play.
The time between these two matches ranged from a few hours to several weeks.
|
|
Active Comparator: 1 referee
One referee was present on the field during these youth soccer matches.
|
We compared player behavior with one versus three referees present on youth soccer fields during match play.
The time between these two matches ranged from a few hours to several weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Number of Injuries During Soccer Matches
Time Frame: baseline through one hour, which is beginning of the game until the end of the game, averaged across games
|
average number of injury events requiring player to leave the field or be attended by an adult, across all games in study
|
baseline through one hour, which is beginning of the game until the end of the game, averaged across games
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Schwebel, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2017
Primary Completion (Actual)
November 11, 2017
Study Completion (Actual)
November 11, 2017
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 10, 2020
First Posted (Actual)
February 12, 2020
Study Record Updates
Last Update Posted (Actual)
May 20, 2020
Last Update Submitted That Met QC Criteria
May 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X160720002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be shared with qualified experts upon request by email to study PI David Schwebel
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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