NCT04869566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

April 28, 2021

Last Update Submit

September 15, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of participants that had occurred an injury during the last year

    Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.

    12 months

  • Number of participants with one ore several mental stressors related to environmental and social conditions

    Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.

    12 months

Study Arms (1)

Athletes with traumatic knee injury

Youth athletes, aged 16-19, with traumatic knee injury

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Traumatic knee injury prior to sport high school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofia Ryman Augustsson

Kalmar, 391 82, Sweden

Location

Study Officials

  • Sofia Ryman Augustsson, PhD

    sofia.rymanaugustsson@lnu.se

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiociate Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations