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Sport InjuryNCT06325228

Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes

An observational study of Sport Injury and Healthy, run by Medical University of Gdansk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Read more about this study

Who is it for?
Ages 8 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Sport Injury, Healthy, Injury;Sports
How many people
373 participants
Where
1 sitePoland
Study dates
1 Feb 2023to 20 Dec 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 8 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Young healthy athletes (8-16 years-old) from sports schools, clubs, teams from the territory of the Pomeranian voivodeship, Poland.

Who may be able to join

  • Healthy (without injury, pain, or symptoms)
  • Participation in sports activities (minimum 6 months)
  • Age of 8 to 16 years-old
  • Agreement to participation from parent/guardian

Who cannot join

  • pain or other symptoms related during study
  • lower extremity or trunk surgery in the last 6 months
  • lack of medical approval for participation in sports games

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk

    Gdansk, 80-211

Other trials in Poland

About this study

Official title: Incidence and Relationshipis of Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes. Project: "Science of Healthy Sport"

The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.

The main questions it aims to answer are:

  • Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?
  • Do athletes with high sports specialization will sustain injury in one-year follow-up?
  • Does sports specialization have a relationship with sports performance tests, and quality of life?
  • Does sport specialisation, training volume, geographical factor relate to injury history?
  • Does sports specialisation, injury history differ between sports (individual and team sports)?
  • Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?
Read the detailed description

Recruited young healthy athletes (8-16 years-old) from sports schools, clubs, teams will invited to study. There will be performed assessment, which included:

  • participant characteristics (age, biological age, gender, height, weight, body mass index, sports experience, training workload, sports specialization, history of injuries)
  • sports performance (value of dynamic balance, isometric strength of lower limbs, functional movement patterns)
  • quality of life and health assessment (EQ-5D-Y)
  • geographical factor (Rural, Urban)
  • Sports (Individual, Team)
  • History of Injuries (Localization, Type)

One-year after meetings, there will be send questionaire and phone-call to participants and their coaches/parents in order to obtain information about injuries (location, type, time-loss, etc.).

Keywords
Sports specialization, Young Athletes, Injury prevention, Sports performance
Medical subject headings
Athletic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06325228
Study groupRoleWhat they receive
Young Athletes300 young athletes (boys and girls, 9 - 16 years-old) from clubs, teams, associations, sports classes of various disciplines in the Pomeranian Voivodeship

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with sports injury after one-year follow-up

    Dichotomous assessment (0 = no injury, 1 = injury) based on a telephone interview with the parent/guardian/coach. Conditions to meet: 12 months after the date of examination, and continuity of participation in sports to the date of injury

    Measured: One year after the date of examination

  2. Type, location, duration, and return to sports in participants with injury at one-year follow up

    Assessment based on a telephone interview with the parent/guardian/coach.

    Questions about:

    • exact type of injury (acute or chronic, contact or non-contact)
    • location of injury (anatomic site, e.g. knee)
    • duration of injury (time-loss, in days)
    • return to sports (Does the participant return to sport, yes or no)

    Measured: One year after the date of examination

Secondary outcomes (6)

  1. Sports Specialization

    Sports specialization defined as "intensive year-round training in a single sport at the exclusion of other sports". Where a highly specialized athlete may be able to (1) choose a main sport, (2) participate for greater than 8 months per year in 1 main sport, and (3) quit all other sports to focus on 1 sport.

    Measured: through study completion, an average of 1 year

  2. History of sports-related injuries

    Questionaire - Question about sports-related injuries within sports career (sports participating in trainings and competitions) which included:

    • - exact type of injury (acute or chronic, contact or non-contact)
    • location of injury (anatomic site, e.g. knee)
    • duration of injury (time-loss, in days)

    Answers will be performed from young athlete and coach. If there will be occasion, answers will be matched with answers from parents/guardians.

    Measured: through study completion, an average of 1 year

  3. Health-related quality of life: EQ-5D-Y

    Patient Reported Outcome instruments" EQ-5D-Y - EuroQol Research Foundation - Certified Translation: Polish for Poland. The EQ-5D is a widely used standardized generic measure of HRQOL. A valid and accurate translation of the corresponding original document. A child-friendly version of the EQ-5D (0-100 points, where "0" means the worse quality of life, and "100" means perfect). (EQ-5D is the name of the instrument and is not an acronym.)

    Measured: through study completion, an average of 1 year

  4. Y-Balance Test - dynamic balance test

    Dynamic Balance of the lower extremities (record as reach distance in centimeters "cm" and normalized reach distance in percentages "%")

    Measured: through study completion, an average of 1 year

  5. 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: through study completion, an average of 1 year

  6. Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle

    Hand-Held Dynamometer (HHD) measurement (Laffayette, USA). Isometric Strength (peak force, average force (kilograms), of the lower extremities muscle (gluteus medium, quadriceps, hamstring, triceps surae.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start1 Feb 2023
  3. Primary completion20 Dec 2025
  4. Study completion20 Dec 2025

Resources

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
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06325228
Sponsor's protocol ID
NKBBN/241/2023
Other IDs
SONP/SP/549693/2022
Status last verified
Dec 2025
First submitted
10 Mar 2024
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The data that will be collected include data sets, i.e., personal survey questionnaires, measurement scales, functional and anthropometric assessment measurements, described in the description section of the scientific activity. Part of the data will be published in the public repository of the Polish Medical Research Platform and the Zenodo repository. Part of the data will be published in scientific journals, which may also require publication of raw data. Data will be made available at the latest at the time of publication. Data are available indefinitely at Polish Medical Research Platform and the Zenodo repository.

Publications

  • Wilczynski B, Radziminski L, Sobierajska-Rek A, de Tillier K, Bracha J, Zorena K. Biological Maturation Predicts Dynamic Balance and Lower Limb Power in Young Football Players. Biology (Basel). 2022 Aug 3;11(8):1167. doi: 10.3390/biology11081167.

    PubMed 36009793

  • Wilczynski B, Radziminski L, Sobierajska-Rek A, Zorena K. Association between Selected Screening Tests and Knee Alignment in Single-Leg Tasks among Young Football Players. Int J Environ Res Public Health. 2022 May 31;19(11):6719. doi: 10.3390/ijerph19116719.

    PubMed 35682301

  • Bruzda R, Wilczynski B, Zorena K. Knee function and quality of life in adolescent soccer players with Osgood Shlatter disease history: a preliminary study. Sci Rep. 2023 Nov 6;13(1):19200. doi: 10.1038/s41598-023-46537-7.

    PubMed 37932373

  • Wilczynski 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

  • Wilczynski B, Buler J, Buler RL, Grochowski ML, Puchalski B, Zorena K. Strength and balance asymmetries in children and adolescents: comparison between single- and multi-sport participants. BMC Sports Sci Med Rehabil. 2025 Nov 27;17(1):358. doi: 10.1186/s13102-025-01420-y.

    PubMed 41310813

Questions about this trial

What is this clinical trial studying?

An observational study of Sport Injury and Healthy, 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 3 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 30 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 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?

Number of Participants with sports injury after one-year follow-up (time frame: One year after the date of examination). 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 NCT06325228, which also lists 5 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 30 Dec 2025.

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