ACL InjuryNCT03479775
Muscle Function and Traumatic Knee Injury in Sports
An observational study of ACL Injury and Meniscus Lesion, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- ACL Injury, Meniscus Lesion, Cartilage Injury
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 12 Sep 2017to Jun 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- Child, Adult
Study population: Female athletes (age 15-19) from Swedish senior high schools who are involved in high risk sports (soccer, handball, floorball and basket).
Who may be able to join
- Female high-school athlete
- age 15-19 y
- must play soccer, handball, floorball or basketplayer
Who cannot join
- illness, which might affect the test results
- injury to the lower extremity at the time of baseline data collection -
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sofia Ryman Augustsson
Kalmar, WV, 39363
Sofia R Ryman Augustsson, PhD, 768288016 ext. 768288016, sofia.rymanaugustsson@gmail.com
Eva Ageberg, Professor, eva.ageberg@med.lu.se
About this study
Official title: The Role of Muscle Function as a Potential Risk and/or Protective Factor for Traumatic Knee Injury in Youth Female Athletes
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.
Read the detailed description
A prospective cohort design will be used for the present study comprising approximately 100 (determined by power analysis) female athletes (age 15-19) from Swedish senior high schools who are involved in high risk sports (soccer, handball, floorball and basket). The study started autumn 2017 with assessment of muscle function at baseline, instructed and supervised by two test leaders. Before the test session the athlete will be informed and tutored about the injury and exposure registration procedure. Measurements takes place in a secluded room at the athletes' school and will be carried out during the first semester (autumn 2017, 2018, 2019 and 2020). Data relating to sport affiliation, number of years of specific sport training, the number of training hours per week and her/his training routines, level of competition and participation in other sports, age, body weight and height will also be conducted using a questionnaire. After the baseline assessment, the athletes will participate in a continuous web based prospective injury registration protocol and be followed for two years.
Outcome measures Data on injury surveillance and exposure (hours of match and training participation) will be collected prospectively over two years using a web-designed (REDCap Software) 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, nature, and diagnosis will be collected by each school's medical staff. The outcome of interest is a traumatic knee injury, i.e., ACL or other ligament injury, meniscal, cartilage damage or fracture, diagnosed by physical examination and/or MRI, arthroscopy.
- Conditions
- ACL Injury, Meniscus Lesion, Cartilage Injury, Ligament Injury
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of traumatic knee injury
Traumatic knee injury will be assessed by a web-designed (REDCap Software) registration form
Measured: 2 years
Muscle strength testing
Muscle strength will be assessed using an isometric handheld dynamometer (Commander Echo, JTECH Medical, Salt Lake City, Utah, USA)
Measured: 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
Measured: Collected during 2 month at 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start12 Sep 2017
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Ryman Augustsson, Study director, Lunds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479775
- Sponsor's protocol ID
- 929-13
- Status last verified
- May 2020
- First submitted
- 20 Mar 2018
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Muscle Function as a Potential Risk and/or Protective Factor for Traumatic Knee Injury in Youth Female Athletes
- ClinicalTrials.gov ID
- NCT03479775
- Acronym / sponsor ID
- 929-13
- Conditions
- ACL Injury, Meniscus Lesion, Cartilage Injury, Ligament Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective cohort design will be used for the present study comprising approximately 100 (determined by power analysis) female athletes (age 15-19) from Swedish senior high schools who are involved in high risk sports (soccer, handball, floorball and basket). The study started autumn 2017 with assessment of muscle function at baseline, instructed and supervised by two test leaders. Before the test session the athlete will be informed and tutored about the injury and exposure registration procedure. Measurements takes place in a secluded room at the athletes' school and will be carried out during the first semester (autumn 2017, 2018, 2019 and 2020). Data relating to sport affiliation, number of years of specific sport training, the number of training hours per week and her/his training routines, level of competition and participation in other sports, age, body weight and height will also be conducted using a questionnaire. After the baseline assessment, the athletes will participate in a continuous web based prospective injury registration protocol and be followed for two years.
Outcome measures Data on injury surveillance and exposure (hours of match and training participation) will be collected prospectively over two years using a web-designed (REDCap Software) 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, nature, and diagnosis will be collected by each school's medical staff. The outcome of interest is a traumatic knee injury, i.e., ACL or other ligament injury, meniscal, cartilage damage or fracture, diagnosed by physical examination and/or MRI, arthroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Female athletes (age 15-19) from Swedish senior high schools who are involved in high risk sports (soccer, handball, floorball and basket).
Key inclusion criteria (3 listed)
- Female high-school athlete
- age 15-19 y
- must play soccer, handball, floorball or basketplayer
Key exclusion criteria (2 listed)
- illness, which might affect the test results
- injury to the lower extremity at the time of baseline data collection -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of traumatic knee injury
Time frame: 2 years
Traumatic knee injury will be assessed by a web-designed (REDCap Software) registration form
Muscle strength testing
Time frame: Collected during 2 month at 1 session
Muscle strength will be assessed using an isometric handheld dynamometer (Commander Echo, JTECH Medical, Salt Lake City, Utah, USA)
Muscular endurance and neuromuscular tests
Time frame: Collected during 2 month at 1 session
Muscular endurance and neuromuscular tests will be video-recorded using the Coach Eye app for smart phone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Ryman Augustsson study director
Lunds University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury and Meniscus Lesion, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of traumatic knee injury (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.