Head InjuryNCT05400551
Craneofacial Injuries in Rink Hockey Athletes
An observational study of Head Injury and Face, run by University of Oviedo at 2 sites in Spain.
Trial summary
To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Face, Concussion, Brain
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2022to 30 Apr 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: athletes that compete in rink hockey, independently of their age or sex
Who may be able to join
- Compete in a spanish rink hockey league
- play at least in one game during ther regular season
Who cannot join
- do not accept the participation in the study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hugo Olmedillas
Oviedo, Principality of Asturias, 33006
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
About this study
Official title: Epidemiology of Craneofacial Injuries in Rink Hockey Athletes
To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.
Read the detailed description
To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (Burden, mechanism, situation, etc)
- Conditions
- Head Injury, Face, Concussion, Brain
- Keywords
- rink hockey, injury, epidemiology, burden
- Medical subject headings
- Craniocerebral Trauma, Facies, Brain Concussion, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants injured
nº of injuries affecting the head or face per time (X/1000h)
Measured: september 2022 to march 2023
days lost due to injury
nº of days lost due to injury affecting the head or face per time (X days/1000h)
Measured: september 2022 to march 2023
Secondary outcomes (2)
usage of helmet
characterise if the player was using a helmet or not when the injury happened
Measured: september 2022 to march 2023
situational characteristics of the injury
register when the injury happened (training or game)
Measured: september 2022 to march 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Sep 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Olmedillas Fernandez, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400551
- Sponsor's protocol ID
- UO2022-01
- Status last verified
- Sep 2022
- First submitted
- 27 May 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Craneofacial Injuries in Rink Hockey Athletes
- ClinicalTrials.gov ID
- NCT05400551
- Acronym / sponsor ID
- UO2022-01
- Conditions
- Head Injury, Face, Concussion, Brain
- Keywords
- rink hockey, injury, epidemiology, burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 1 Jun 2022 (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 collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.
Detailed description
To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (Burden, mechanism, situation, etc)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- athletes that compete in rink hockey, independently of their age or sex
Key inclusion criteria (2 listed)
- Compete in a spanish rink hockey league
- play at least in one game during ther regular season
Key exclusion criteria (1 listed)
- do not accept the participation in the study
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
Number of participants injured
Time frame: september 2022 to march 2023
nº of injuries affecting the head or face per time (X/1000h)
days lost due to injury
Time frame: september 2022 to march 2023
nº of days lost due to injury affecting the head or face per time (X days/1000h)
2 secondary outcomes
usage of helmet
Time frame: september 2022 to march 2023
situational characteristics of the injury
Time frame: september 2022 to march 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Face, run by University of Oviedo at 2 sites in Spain.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
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?
Number of participants injured (time frame: september 2022 to march 2023). The study lists 2 primary outcomes in all. 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 23 Sep 2022.