- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869566
External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kalmar, Sweden, 391 82
- Sofia Ryman Augustsson
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Athletes with traumatic knee injury
Youth athletes, aged 16-19, with traumatic knee injury
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of participants that had occurred an injury during the last year
Time Frame: 12 months
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Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.
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12 months
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Number of participants with one ore several mental stressors related to environmental and social conditions
Time Frame: 12 months
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Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sofia Ryman Augustsson, PhD, sofia.rymanaugustsson@lnu.se
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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