NCT03479775

Brief Summary

The aims of the project are to 1) evaluate different aspects of muscle function and its role as a potential risk and/or protective factor for traumatic knee injury in youth female athletes; 2) develop and evaluate a battery of muscle function tests, easily used and requiring minimal equipment, to be applied as an on-the-field screening tool to detect muscle function deficiencies and monitoring youth female athletes at high risk of traumatic knee injury. A prospective cohort design will be used, including approximately 100 female athletes (age 15-19) from Swedish senior sports high schools who are involved in high risk sports (soccer, handball, floorball and basket). A test battery for muscle function has been developed consisting of 11 tests that previously have been used for the assessment of muscle function. The tests will be instructed and supervised by educated test leaders. Measurements will take place at the athletes' school and carried out during the first semester (autumn 2017 and 2018). Data on injury surveillance and exposure (hours of match and training participation) will be collected prospectively over two years using a web-designed registration form. All athletes will on a weekly basis report their hours of training, minutes of match play and all time-loss injuries occurring during sport activity. Details on injury mechanism and diagnosis will be collected by each school's medical staff. The present study will contribute new knowledge on the role of muscle function and develop and evaluate a battery of muscle function tests to be used as an on-the-field screening tool for monitoring youth female athletes at high risk of traumatic knee injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 12, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

3.6 years

First QC Date

March 20, 2018

Last Update Submit

May 28, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of traumatic knee injury

    Traumatic knee injury will be assessed by a web-designed (REDCap Software) registration form

    2 years

  • Muscle strength testing

    Muscle strength will be assessed using an isometric handheld dynamometer (Commander Echo, JTECH Medical, Salt Lake City, Utah, USA)

    Collected during 2 month at 1 session

  • Muscular endurance and neuromuscular tests

    Muscular endurance and neuromuscular tests will be video-recorded using the Coach Eye app for smart phone

    Collected during 2 month at 1 session

Study Arms (2)

Youth female athletes with poor muscle function

Youth female athletes (floorball, football and handball) with assessed poor muscle function at baseline.

Youth female athletes with good muscle function

Youth female athletes (floorball, football and handball) with assessed good muscle function at baseline.

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female athletes (age 15-19) from Swedish senior high schools who are involved in high risk sports (soccer, handball, floorball and basket).

You may qualify if:

  • Female high-school athlete
  • age 15-19 y
  • must play soccer, handball, floorball or basketplayer

You may not qualify if:

  • illness, which might affect the test results
  • injury to the lower extremity at the time of baseline data collection -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofia Ryman Augustsson

Kalmar, WV, 39363, Sweden

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Sofia Ryman Augustsson

    Lunds University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

September 12, 2017

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations