Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Header Burden in Football (Soccer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868553
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Universität des Saarlandes

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the realistic magnitude of the header burden in children's and youth' football in eight European countries. In a cross-sectional observational design, one match of 60 different teams in each of the eight European countries were monitored via video recording throughout the second half of the regular season 2017/18 and the first half of the regular season 2018/19. Clubs with (female, male, or mixed) Under-10, Under-12 and female and male Under-16 teams were invited to participate. Header frequencies and types were analysed using standardized heading registration forms. Additionally, head injuries were recorded using standardized head injury registration forms.

Condition or disease Intervention/treatment
Header Frequencies, Head Injuries Other: No intervention

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Header Burden in Children's and Youth' Football (Soccer)
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Under-10 Other: No intervention
observational study
Under-12 Other: No intervention
observational study
Under-16 female Other: No intervention
observational study
Under-16 male Other: No intervention
observational study


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Header frequency [ Time Frame: 2018 ]
    Total number of headers and further observations during match play and training sessions


Secondary Outcome Measures :
  1. Head injuries [ Time Frame: 2018 ]
    Head injuries during match play and training sessions


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Football (soccer) playing children and adolescents
Criteria

Inclusion Criteria:

  • 1) officially registered in the football association
  • 2) regular training participation
  • 3) regular participation in official matches
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868553


Locations
Layout table for location information
Germany
Saarland University
Saarbrücken, Saarland, Germany, 66123
Sponsors and Collaborators
Universität des Saarlandes
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT03868553    
Other Study ID Numbers: Saarland Header Study
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data were recorded anonymously.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries