Header Frequencies, Head InjuriesNCT03868553
Header Burden in Football (Soccer)
An observational study of Header Frequencies, Head Injuries, run by Universität des Saarlandes at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Header Frequencies, Head Injuries
- How many people
- 480 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Football (soccer) playing children and adolescents
Who may be able to join
- 1) officially registered in the football association
- 2) regular training participation
- 3) regular participation in official matches
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Header Frequencies, Head Injuries
- Being tested
- No intervention
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| Under-10 | Not described Receives: Other: No intervention | |
| Under-12 | Not described Receives: Other: No intervention | |
| Under-16 female | Not described Receives: Other: No intervention | |
| Under-16 male | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Header frequency
Total number of headers and further observations during match play and training sessions
Measured: 2018
Secondary outcomes (1)
Head injuries
Head injuries during match play and training sessions
Measured: 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Jan 2018
- Primary completion20 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Header Frequencies, Head InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868553
- Sponsor's protocol ID
- Saarland Header Study
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data were recorded anonymously.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Header Burden in Children's and Youth' Football (Soccer)
- ClinicalTrials.gov ID
- NCT03868553
- Acronym / sponsor ID
- Saarland Header Study
- Conditions
- Header Frequencies, Head Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Under-10 | – | Other: No intervention |
| Under-12 | – | Other: No intervention |
| Under-16 female | – | Other: No intervention |
| Under-16 male | – | Other: No intervention |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Football (soccer) playing children and adolescents
Key inclusion criteria (3 listed)
- 1) officially registered in the football association
- 2) regular training participation
- 3) regular participation in official matches
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionobservational study | Other | Under-10, Under-12, Under-16 female, Under-16 male |
Primary outcome
Header frequency
Time frame: 2018
Total number of headers and further observations during match play and training sessions
1 secondary outcome
Head injuries
Time frame: 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No. Data were recorded anonymously.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Header Frequencies, Head Injuries, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Header frequency (time frame: 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.