Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03868553
Other study ID # Saarland Header Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Saarland University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date December 31, 2018
Est. primary completion date December 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria:

- 1) officially registered in the football association

- 2) regular training participation

- 3) regular participation in official matches

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
observational study

Locations

Country Name City State
Germany Saarland University Saarbrücken Saarland

Sponsors (1)

Lead Sponsor Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Header frequency Total number of headers and further observations during match play and training sessions 2018
Secondary Head injuries Head injuries during match play and training sessions 2018