Header Burden in Football (Soccer) | NCT03868553

Studies
Header Burden in Football (Soccer)

NCT03868553

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Mar 11, 2019Actual

Enrollment

480Actual

Phase

Not provided

Conditions

Header Frequencies, Head Injuries

Interventions

No intervention

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 7, 2019

First Submission Date that Met QC Criteria

Mar 7, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2019

Last Update Posted Date

Mar 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Under-10			Other: No intervention
Under-12			Other: No intervention
Under-16 female			Other: No intervention
Under-16 male			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	observational study	Under-10 Under-12 Under-16 female Under-16 male

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Header frequency	Total number of headers and further observations during match play and training sessions	2018

Secondary Outcomes

Measure	Description	Time Frame
Head injuries	Head injuries during match play and training sessions	2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) officially registered in the football association
2) regular training participation
3) regular participation in official matches

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Football (soccer) playing children and adolescents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saarland University		Saarbrücken	Saarland	66123	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Data were recorded anonymously.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided