Musculoskeletal DiseasesNCT04780880
Incidence and Prognostic Factors for Lower Extremities Injuries in Polish Youth Soccer Academy.
An observational study of Musculoskeletal Diseases and Athletic Injuries, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The aim of our study is to obtain data on the occurrence of injuries, their mechanisms and types among children and adolescents from a youth soccer club. In addition, in order to determine the potential risk of injury, the investigators will examine the prognostic factors on the basis of tests assessing the… Read more about this study
- Who is it for?
- Ages 10 to 16 years, men only
- Conditions the study is for
- Musculoskeletal Diseases, Athletic Injuries
- How many people
- 0 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2021to 10 Jan 2025
- 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 10 to 16 years
- Men only
- Child
Study population: Young male footballers (U10-U16) training and competing in a Polish football club.
Who may be able to join
- healthy, not reporting health problems on the day of the examination
- active participation in football competitions in the football club
- having a medical permit to participate in football games
- signed consent of the parent / guardian to participate in the study
Who cannot join
- unable to participate in the study
- restrictions related to full participation in football games and / or training
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
Gdansk, 80-211
About this study
The aim of our study is to obtain data on the occurrence of injuries, their mechanisms and types among children and adolescents from a youth soccer club. In addition, in order to determine the potential risk of injury, the investigators will examine the prognostic factors on the basis of tests assessing the antropometric, anatomical, physical and fitness characteristics.
Read the detailed description
During the 2020/2023 seasons, participants will be obliged to report injuries to to sports physiotherapists.
Supervision and data collection on injuries will be documented by experienced sports physiotherapists. Using the Injury Record Form, a standardized definition and classification of injuries in line with the International Olympic Committee Consensus describing methods for recording and reporting epidemiological data on injuries and diseases in sport (Bahr et al. 2020). In addition, the data will also come from a physiotherapeutic examination, and in the case of severe injuries (requiring specialist consultation), a medical examination (orthopedic and / or neurological) and imaging tests.
Training and match exhibition (time spent by participants during training units and match games) will be recorded individually for each participant by the coaches of a given team (year). The given data (in minutes) will allow to determine the total time of sports exposure. The participant's missed training and / or competition due to an injury will also be analyzed.
- Conditions
- Musculoskeletal Diseases, Athletic Injuries
- Medical subject headings
- Musculoskeletal Diseases, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Youth football players | Young footballers aged 10-16 training and playing for a Polish football club. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of sports-related injuries in youth athletics
Injury incidence rates were calculated per 1000 player hours (matches and training) According to a consensus statement on injury definitions and data collection procedures in soccer studies;
Measured: Injury incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
The incidence of recurrent sports-related injuries
According to a consensus statement on injury definitions and data collection procedures in soccer studies;
Measured: Recurrent injuries incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
Secondary outcomes (9)
Injury severity
Time loss in days (days unable to train)
Measured: Injury severity were calculated per days of rehabilitation over the 12-month prospective follow-up
Injuries according to location
Location of the injury on the body
Measured: Description of the number of injuries according to location of the injury on the body over the 12-month prospective follow-up
Injuries according to type of the injury
Type of the injured structure
Measured: Description of injuries according to the type of the injury over the 12-month prospective follow-up
Muscle flexibility and range of joint motion
Muscle flexibility, range of joint mobility (degrees as measured by a goniometer)
Measured: over the 12-month prospective follow-up
Peak Height Velocity
Peak Height Velocity (PHV) calculated using the 'maturity offset' value (report as "PHV years")
Measured: over the 12-month prospective follow-up
Y-Balance Test
Dynamic Balance of the lower extremities (record as reach distance in centimeters "cm" and normalized reach distance in percentages "%")
Measured: over the 12-month prospective follow-up
Counter Movement Jump, Broad Jump and Single Leg Hop for Distance
Power of the lower limbs measured as distance in single-leg and double-leg jump tasks (record as distance in centimeters "cm")
Measured: over the 12-month prospective follow-up
Functional Movement Screen (FMS)
The Functional Movement Screen (FMS) is a screening tool used to identify limitations or asymmetries in movement patterns. FMS consists of 7 movement tasks (deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility, and rotary stability). Each task will be visually assessed by an experienced physiotherapist and marked on a 4-point scale (0-3, worst-best). The total maximum score that can be obtained is 21 points.
Measured: over the 12-month prospective follow-up
Kinematic analysis of the single-leg movement tasks
Kinematic analysis of the single-leg movement tasks (single-leg squat, single-leg landing) - 2D video analysis - record as degrees of motion of the joints
Measured: over the 12-month prospective follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start5 Jan 2021
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Why it stopped: Study halted prior to enrollment due to logistical challenges and failure to recruit eligible athletes from participating soccer academies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartosz Wilczyński, Principal investigator, Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780880
- Sponsor's protocol ID
- NKBBN/680/2020
- Other IDs
- NKBBN/680/2020
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilczynski B, Zorena K, Slezak D. Dynamic Knee Valgus in Single-Leg Movement Tasks. Potentially Modifiable Factors and Exercise Training Options. A Literature Review. Int J Environ Res Public Health. 2020 Nov 6;17(21):8208. doi: 10.3390/ijerph17218208.
PubMed 33172101Wilczynski B, Hinca J, Slezak D, Zorena K. The Relationship between Dynamic Balance and Jumping Tests among Adolescent Amateur Rugby Players. A Preliminary Study. Int J Environ Res Public Health. 2021 Jan 4;18(1):312. doi: 10.3390/ijerph18010312.
PubMed 33406658
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Prognostic Factors for Lower Extremities Injuries in Polish Youth Soccer Academy.
- ClinicalTrials.gov ID
- NCT04780880
- Acronym / sponsor ID
- NKBBN/680/2020
- Conditions
- Musculoskeletal Diseases, Athletic Injuries
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted prior to enrollment due to logistical challenges and failure to recruit eligible athletes from participating soccer academies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 4 Mar 2021 (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.
The aim of our study is to obtain data on the occurrence of injuries, their mechanisms and types among children and adolescents from a youth soccer club. In addition, in order to determine the potential risk of injury, the investigators will examine the prognostic factors on the basis of tests assessing the antropometric, anatomical, physical and fitness characteristics.
Detailed description
During the 2020/2023 seasons, participants will be obliged to report injuries to to sports physiotherapists.
Supervision and data collection on injuries will be documented by experienced sports physiotherapists. Using the Injury Record Form, a standardized definition and classification of injuries in line with the International Olympic Committee Consensus describing methods for recording and reporting epidemiological data on injuries and diseases in sport (Bahr et al. 2020). In addition, the data will also come from a physiotherapeutic examination, and in the case of severe injuries (requiring specialist consultation), a medical examination (orthopedic and / or neurological) and imaging tests.
Training and match exhibition (time spent by participants during training units and match games) will be recorded individually for each participant by the coaches of a given team (year). The given data (in minutes) will allow to determine the total time of sports exposure. The participant's missed training and / or competition due to an injury will also be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth football players | – | –Young footballers aged 10-16 training and playing for a Polish football club. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Male only
- Age groups
- Child
- Study population
- Young male footballers (U10-U16) training and competing in a Polish football club.
Key inclusion criteria (4 listed)
- healthy, not reporting health problems on the day of the examination
- active participation in football competitions in the football club
- having a medical permit to participate in football games
- signed consent of the parent / guardian to participate in the study
Key exclusion criteria (2 listed)
- unable to participate in the study
- restrictions related to full participation in football games and / or training
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
The incidence of sports-related injuries in youth athletics
Time frame: Injury incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
Injury incidence rates were calculated per 1000 player hours (matches and training) According to a consensus statement on injury definitions and data collection procedures in soccer studies;
The incidence of recurrent sports-related injuries
Time frame: Recurrent injuries incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
According to a consensus statement on injury definitions and data collection procedures in soccer studies;
9 secondary outcomes
Injury severity
Time frame: Injury severity were calculated per days of rehabilitation over the 12-month prospective follow-up
Injuries according to location
Time frame: Description of the number of injuries according to location of the injury on the body over the 12-month prospective follow-up
Injuries according to type of the injury
Time frame: Description of injuries according to the type of the injury over the 12-month prospective follow-up
Muscle flexibility and range of joint motion
Time frame: over the 12-month prospective follow-up
Peak Height Velocity
Time frame: over the 12-month prospective follow-up
Y-Balance Test
Time frame: over the 12-month prospective follow-up
Counter Movement Jump, Broad Jump and Single Leg Hop for Distance
Time frame: over the 12-month prospective follow-up
Functional Movement Screen (FMS)
Time frame: over the 12-month prospective follow-up
Kinematic analysis of the single-leg movement tasks
Time frame: over the 12-month prospective follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 33172101Wilczynski B, Zorena K, Slezak D. Dynamic Knee Valgus in Single-Leg Movement Tasks. Potentially Modifiable Factors and Exercise Training Options. A Literature Review. Int J Environ Res Public Health. 2020 Nov 6;17(21):8208. doi: 10.3390/ijerph17218208.
- Background: PubMed 33406658Wilczynski B, Hinca J, Slezak D, Zorena K. The Relationship between Dynamic Balance and Jumping Tests among Adolescent Amateur Rugby Players. A Preliminary Study. Int J Environ Res Public Health. 2021 Jan 4;18(1):312. doi: 10.3390/ijerph18010312.
- Individual participant dataSharing planned: Undecided
Related trials for Musculoskeletal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Bartosz Wilczyński principal investigator
Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
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 Musculoskeletal Diseases and Athletic Injuries, run by Medical University of Gdansk at 1 site in Poland.
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 4 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: withdrawn, as of the sponsor's last update on 3 Dec 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 Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
The incidence of sports-related injuries in youth athletics (time frame: Injury incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up). 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?
On the ClinicalTrials.gov record for NCT04780880, which also lists 2 linked publications.
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 3 Dec 2025.