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External Stressors Prior to Traumatic Knee Injury in Youth Athletes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869566
Recruitment Status : Completed
First Posted : May 3, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Sofia Ryman Augustsson, Linnaeus University

Study Description
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Brief Summary:

The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.

The present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.


Condition or disease
Traumatic Knee Injury

Study Design
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Study Type : Observational
Actual Enrollment : 329 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Athletes with traumatic knee injury
Youth athletes, aged 16-19, with traumatic knee injury


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants that had occurred an injury during the last year [ Time Frame: 12 months ]
    Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.

  2. Number of participants with one ore several mental stressors related to environmental and social conditions [ Time Frame: 12 months ]
    Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden, will be contacted and introduced to the study through email. The team coach at each school will distribute a web-based form to the athletes during their first, second or third year of the high-school period by email or through the school's intra-net system.

We estimate that approximately 300 youth athletes (50% women) will be included. From the included participants, ahtletes with traumatic knee injury will be included for furhter analysis.

Criteria

Inclusion Criteria:

Male and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball

Exclusion Criteria:

Traumatic knee injury prior to sport high school.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869566


Locations
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Sweden
Sofia Ryman Augustsson
Kalmar, Sweden, 391 82
Sponsors and Collaborators
Linnaeus University
Investigators
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Principal Investigator: Sofia Ryman Augustsson, PhD sofia.rymanaugustsson@lnu.se
More Information
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Responsible Party: Sofia Ryman Augustsson, Assiociate Professor, Linnaeus University
ClinicalTrials.gov Identifier: NCT04869566    
Other Study ID Numbers: 2019-02609
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Leg Injuries