- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868553
Header Burden in Football (Soccer)
March 7, 2019 updated by: Universität des Saarlandes
The Header Burden in Children's and Youth' Football (Soccer)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
480
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
-
-
Saarland
-
Saarbrücken, Saarland, Germany, 66123
- Saarland University
-
-
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 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Football (soccer) playing children and adolescents
Description
Inclusion Criteria:
- 1) officially registered in the football association
- 2) regular training participation
- 3) regular participation in official matches
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Under-10
|
observational study
|
Under-12
|
observational study
|
Under-16 female
|
observational study
|
Under-16 male
|
observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Header frequency
Time Frame: 2018
|
Total number of headers and further observations during match play and training sessions
|
2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Head injuries
Time Frame: 2018
|
Head injuries during match play and training sessions
|
2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2018
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
March 7, 2019
First Submitted That Met QC Criteria
March 7, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 7, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Saarland Header Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data were recorded anonymously.
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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Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States
-
Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States, Uganda
-
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-
Vinmec Research Institute of Stem Cell and Gene...RecruitingSequelae of Injuries of HeadVietnam
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