Sports-related ConcussionREFORMNCT07128706
Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the Erasmus + Project
An observational study of Sports-related Concussion, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study addresses the evident gap in SRC awareness and reporting, especially at the grassroots level, by harmonizing concussion management practices across Europe and observing its impact on stakeholders' (coaches, parents, players, referees) knowledge and practices. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sports-related Concussion
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Coaches, referees, parents and youth football players (up to U23) involved in football federations among Croatia, Norway, Germany and Turkey.
Who may be able to join
- Clubs: Youth football clubs in the four countries will be invited to participate. Clubs must have:
- The ability to implement new concussion protocols with support from the project team. This will include basic resources such as access to digital platforms (e.g., internet connectivity, devices to access training materials).
- A willingness to engage with and integrate educational materials into their regular operations. Federations will support clubs in understanding these expectations before participation.
- Stakeholders: Key stakeholder groups involved in youth football will be included:
- Coaches of youth teams, regardless of prior experience in concussion management.
- Players actively participating in youth football (targeting diverse age groups and genders).
Show all 9Show fewer
- Parents of youth players to ensure comprehensive inclusion of perspectives.
- Referees involved in officiating youth football matches.
- Medical personnel, including team doctors and physiotherapists.
Who cannot join
- Clubs that lack the basic resources or logistical capacity to access digital learning platforms or implement concussion protocols (as determined by federations).
- Stakeholders who are unwilling to participate or unable to provide informed consent (or, for minors, parental/guardian consent).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the REFORM Erasmus + Project
This study addresses the evident gap in SRC awareness and reporting, especially at the grassroots level, by harmonizing concussion management practices across Europe and observing its impact on stakeholders' (coaches, parents, players, referees) knowledge and practices.
Read the detailed description
This project is a multi-phase observational study using a participatory action research design. It includes the identification, documentation, and evaluation of educational tools to improve concussion management practices in European youth football. Each phase of the study is guided by the Logical Framework Approach (LFA) to ensure systematic evaluation and measurable outcomes.
The project adopts a stakeholder-centered methodology, involving key stakeholders, including football associations, healthcare professionals, and academia, from Norway, Germany, Croatia, and Türkiye. This structured approach ensures that each phase aligns with specific objectives, outputs, and outcomes, enhancing the project's coherence and impact. The LFA was chosen for its structured, outcome-oriented methodology, which aligns well with the goals of this multi-phase, transnational project. LFA facilitates clear goal-setting, stakeholder engagement, and systematic monitoring, ensuring alignment between the project's objectives and measurable outcomes. Compared to other participatory research approaches, LFA's emphasis on stakeholder-driven planning ensures that the developed educational tools are practical, culturally relevant, and widely applicable across diverse European football contexts.
The project will use a stakeholder approach to collaboratively observe, assess, and document innovative educational materials and resources for concussion awareness that emerging in routine practice. This process will be interdisciplinary and transnational, ensuring that the materials are harmonized and build upon each other to meet the needs of various stakeholders. The project will use surveys to articulate training and educational standards to ensure a high-quality standard that can be scaled across European national football associations down to grassroots levels in each country.
Through a participatory process, the project will solicit expert opinion and keep an ongoing dialogue with multiple facets of stakeholders to guarantee an evidence-based joint European educational awareness set that meets the demands of the coaches and board, as well as fostering an awareness in the players and their families.
Setting and Participants The project will be conducted in collaboration with football associations from Norway, Germany, Croatia, and Türkiye. Participants will include selected football clubs from these countries, chosen to represent diverse cultural and operational contexts.
To ensure the educational materials are effective across the diverse cultural contexts of the participating countries, the project will implement a robust process of cultural adaptation. This will involve the translation of educational materials into the native languages of each participating country, ensuring accuracy and clarity in communication. UEFA-approved translators will be used to maintain the integrity of the content.
Additionally, local experts, football stakeholders, and national football federations will play an active role in providing culturally specific insights throughout the development phase. This collaborative approach ensures that the content resonates with the distinct cultural contexts, communication styles, and practices of each country. Focus group discussions and pilot testing will be conducted in each country to refine the materials further, ensuring their relevance and effectiveness in addressing regional nuances related to concussion management.
The dissemination phase employs a multi-channel strategy, combining direct stakeholder engagement with digital tools and institutional partnerships to reach diverse audiences across Europe. Resources will be shared with national football associations for scaling across Europe, leveraging social media platforms to enhance outreach. The findings of this project will be analyzed and published in peer-reviewed journals, as well as presented at key conferences. All findings will be disseminated to accurately inform future practices. This will occur immediately after the completion of the final analysis.
- Conditions
- Sports-related Concussion
- Keywords
- awareness, european football, youth, sports-related concussions, management, education
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Concussion Knowledge Score Pre- and Post-Educational Toolkit
Concussion knowledge will be assessed using a structured multiple-choice questionnaire developed for this study, based on international concussion education guidelines. The same test will be administered immediately before the educational intervention (toolkit) and within 4 weeks after completion. Each correct answer is scored as 1 point. The total score ranges from 0 to 25. Higher scores indicate greater knowledge.
Measured: Baseline (pre-intervention) and up to 4 weeks post-intervention
Secondary outcomes (3)
Number of Participants Completing the Online Concussion Education Course (MOOC)
Engagement with the online concussion education course will be measured by tracking completion data through the course platform. Completion is defined as finishing all mandatory modules and quizzes. Data will be automatically recorded and exported from the course analytics dashboard.
Measured: Within 6 weeks after enrollment in the course
Number of Clubs Utilizing the Educational Toolkit
Toolkit utilization will be assessed via club reports and checklists submitted at the end of the intervention period. Clubs will indicate which toolkit components (e.g., posters, handouts, team briefings) were used. A club is considered a user if at least one core component was implemented.
Measured: Up to 3 months after intervention rollout
Number of Participants Attending Live Concussion Education Workshops
Attendance at live in-person or virtual workshops will be tracked through registration lists and sign-in sheets. Workshop participation will be considered complete if the participant attended at least 80% of the session.
Measured: Throughout the intervention period (approx. 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Jan 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports-related ConcussionStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Universität des Saarlandes, UiT The Arctic University of Norway, University Hospital of Split
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128706
- Sponsor's protocol ID
- 101133951
- Acronym
- REFORM
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data are anonymously collected
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the REFORM Erasmus + Project
- ClinicalTrials.gov ID
- NCT07128706
- Acronym / sponsor ID
- REFORM / 101133951
- Conditions
- Sports-related Concussion
- Keywords
- awareness, european football, youth, sports-related concussions, management, education
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Universität des Saarlandes, UiT The Arctic University of Norway, University Hospital of Split
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
This study addresses the evident gap in SRC awareness and reporting, especially at the grassroots level, by harmonizing concussion management practices across Europe and observing its impact on stakeholders' (coaches, parents, players, referees) knowledge and practices.
Detailed description
This project is a multi-phase observational study using a participatory action research design. It includes the identification, documentation, and evaluation of educational tools to improve concussion management practices in European youth football. Each phase of the study is guided by the Logical Framework Approach (LFA) to ensure systematic evaluation and measurable outcomes.
The project adopts a stakeholder-centered methodology, involving key stakeholders, including football associations, healthcare professionals, and academia, from Norway, Germany, Croatia, and Türkiye. This structured approach ensures that each phase aligns with specific objectives, outputs, and outcomes, enhancing the project's coherence and impact. The LFA was chosen for its structured, outcome-oriented methodology, which aligns well with the goals of this multi-phase, transnational project. LFA facilitates clear goal-setting, stakeholder engagement, and systematic monitoring, ensuring alignment between the project's objectives and measurable outcomes. Compared to other participatory research approaches, LFA's emphasis on stakeholder-driven planning ensures that the developed educational tools are practical, culturally relevant, and widely applicable across diverse European football contexts.
The project will use a stakeholder approach to collaboratively observe, assess, and document innovative educational materials and resources for concussion awareness that emerging in routine practice. This process will be interdisciplinary and transnational, ensuring that the materials are harmonized and build upon each other to meet the needs of various stakeholders. The project will use surveys to articulate training and educational standards to ensure a high-quality standard that can be scaled across European national football associations down to grassroots levels in each country.
Through a participatory process, the project will solicit expert opinion and keep an ongoing dialogue with multiple facets of stakeholders to guarantee an evidence-based joint European educational awareness set that meets the demands of the coaches and board, as well as fostering an awareness in the players and their families.
Setting and Participants The project will be conducted in collaboration with football associations from Norway, Germany, Croatia, and Türkiye. Participants will include selected football clubs from these countries, chosen to represent diverse cultural and operational contexts.
To ensure the educational materials are effective across the diverse cultural contexts of the participating countries, the project will implement a robust process of cultural adaptation. This will involve the translation of educational materials into the native languages of each participating country, ensuring accuracy and clarity in communication. UEFA-approved translators will be used to maintain the integrity of the content.
Additionally, local experts, football stakeholders, and national football federations will play an active role in providing culturally specific insights throughout the development phase. This collaborative approach ensures that the content resonates with the distinct cultural contexts, communication styles, and practices of each country. Focus group discussions and pilot testing will be conducted in each country to refine the materials further, ensuring their relevance and effectiveness in addressing regional nuances related to concussion management.
The dissemination phase employs a multi-channel strategy, combining direct stakeholder engagement with digital tools and institutional partnerships to reach diverse audiences across Europe. Resources will be shared with national football associations for scaling across Europe, leveraging social media platforms to enhance outreach. The findings of this project will be analyzed and published in peer-reviewed journals, as well as presented at key conferences. All findings will be disseminated to accurately inform future practices. This will occur immediately after the completion of the final analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Coaches, referees, parents and youth football players (up to U23) involved in football federations among Croatia, Norway, Germany and Turkey.
Key inclusion criteria (9 listed)
- Clubs: Youth football clubs in the four countries will be invited to participate. Clubs must have:
- The ability to implement new concussion protocols with support from the project team. This will include basic resources such as access to digital platforms (e.g., internet connectivity, devices to access training materials).
- A willingness to engage with and integrate educational materials into their regular operations. Federations will support clubs in understanding these expectations before participation.
- Coaches of youth teams, regardless of prior experience in concussion management.
- Players actively participating in youth football (targeting diverse age groups and genders).
Key exclusion criteria (2 listed)
- Clubs that lack the basic resources or logistical capacity to access digital learning platforms or implement concussion protocols (as determined by federations).
- Stakeholders who are unwilling to participate or unable to provide informed consent (or, for minors, parental/guardian consent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Concussion Knowledge Score Pre- and Post-Educational Toolkit
Time frame: Baseline (pre-intervention) and up to 4 weeks post-intervention
Concussion knowledge will be assessed using a structured multiple-choice questionnaire developed for this study, based on international concussion education guidelines. The same test will be administered immediately before the educational intervention (toolkit) and within 4 weeks after completion. Each correct answer is scored as 1 point. The total score ranges from 0 to 25. Higher scores indicate greater knowledge.
3 secondary outcomes
Number of Participants Completing the Online Concussion Education Course (MOOC)
Time frame: Within 6 weeks after enrollment in the course
Number of Clubs Utilizing the Educational Toolkit
Time frame: Up to 3 months after intervention rollout
Number of Participants Attending Live Concussion Education Workshops
Time frame: Throughout the intervention period (approx. 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. data are anonymously collected
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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.
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 Sports-related Concussion, run by Acibadem University at 1 site in Turkey (Türkiye).
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 9 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 Aug 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Concussion Knowledge Score Pre- and Post-Educational Toolkit (time frame: Baseline (pre-intervention) and up to 4 weeks post-intervention). 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 19 Aug 2025.