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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04780880
Other study ID # NKBBN/680/2020
Secondary ID NKBBN/680/2020
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2021
Est. completion date December 2024

Study information

Verified date February 2024
Source Medical University of Gdansk
Contact Bartosz Wilczynski
Phone +48 732 414 195
Email bartosz.wilczynski@gumed.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 antropometric, anatomical, physical and fitness characteristics.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender Male
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - unable to participate in the study - restrictions related to full participation in football games and / or training

Study Design


Locations

Country Name City State
Poland Department of Immunobiology and Environment Microbiology, Medical University of Gdansk Gdansk

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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; Injury incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
Primary The incidence of recurrent sports-related injuries According to a consensus statement on injury definitions and data collection procedures in soccer studies; Recurrent injuries incidence rates were calculated per 1000 hours of play over the 12-month prospective follow-up
Secondary Injury severity Time loss in days (days unable to train) Injury severity were calculated per days of rehabilitation over the 12-month prospective follow-up
Secondary Injuries according to location Location of the injury on the body Description of the number of injuries according to location of the injury on the body over the 12-month prospective follow-up
Secondary Injuries according to type of the injury Type of the injured structure Description of injuries according to the type of the injury over the 12-month prospective follow-up
Secondary Muscle flexibility and range of joint motion Muscle flexibility, range of joint mobility (degrees as measured by a goniometer) over the 12-month prospective follow-up
Secondary Peak Height Velocity Peak Height Velocity (PHV) calculated using the 'maturity offset' value (report as "PHV years") over the 12-month prospective follow-up
Secondary Y-Balance Test Dynamic Balance of the lower extremities (record as reach distance in centimeters "cm" and normalized reach distance in percentages "%") over the 12-month prospective follow-up
Secondary 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") over the 12-month prospective follow-up
Secondary 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. over the 12-month prospective follow-up
Secondary 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 over the 12-month prospective follow-up
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