Ankle InjuriesNCT05323773
How is Calf Muscle Endurance Related to Ankle Injuries in TeamGym Athletes?
An observational study of Ankle Injuries and Foot Injury, run by Susanne Beischer at 1 site in Sweden.
Trial summary
The specific aims of this study are to: describe how many heel raises and side hops TG athletes of various ages can perform and how far they can jump, one leg at a time. examine how calf muscle endurance and hop performance are related to the risk of new injuries in the foot, ankle, and lower leg in TG athletes. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Foot Injury, Overuse Injury
- How many people
- 107 participants
- Where
- 1 siteSweden
- Study dates
- 30 Apr 2022to 12 Oct 2023
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: TeamGym athletes (members of the Swedish Gymnastics Federation) in Gothenburg, Sweden.
Who may be able to join
- Regular participation in TeamGym training (at least once per week)
- Understanding written and spoken Swedish
Who cannot join
- Recent (defined as: in the last 4 weeks before baseline testing) injury to the foot, ankle, or lower leg = exclusion from hop tests.
- Presence of other injuries to the lower limb or spine that may be accentuated or affect test results.
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of this study are to:
- describe how many heel raises and side hops TG athletes of various ages can perform and how far they can jump, one leg at a time.
- examine how calf muscle endurance and hop performance are related to the risk of new injuries in the foot, ankle, and lower leg in TG athletes.
The investigators hypothesise that atletes with superior performance in the tests for muscular endurance and hop performance will report fewer injuries during the follow up period.
Read the detailed description
TeamGym (TG) is the most common gymnastics discipline in Sweden. There is a relatively high injury incidence of 2,2-3,4 injuries per 1000 hours of gymnastic activity. Muscular fatigue has been proposed as a risk factor for sustaining an injury in gymnastics, but this has yet not been examined.
In TG, the lower extremity is more susceptible to injuries than the spine and upper extremity, with injury rates ranging between 60 - 77% for the lower extremity. More specifically, the foot, ankle, and the lower leg account for 40 - 56% of all reported injuries, consisting mostly of ankle injuries.
In clinical and research settings, heel raises and side hops are commonly used to assess muscular endurance in the lower leg. Furthermore, it is common to also include a hop performance test to assess the physical capacity of an athlete following an injury to the foot, ankle, or lower leg. However, there are normative values published of the aforementioned tests, in TG athletes
The overall purpose of this project is to facilitate and improve the caretaking of TG athletes who have sustained various types of injuries in the foot, ankle and lower leg.
Specific aims are to:
- describe how many heel raises and side hops TG athletes of various ages can perform and how far they can jump, one leg at a time.
- examine how calf muscle endurance and hop performance are related to the risk of new injuries in the foot, ankle, and lower leg in TG athletes.
The investigatorshypothesise that atletes with superior performance in the tests for muscular endurance and hop performance will report fewer injuries during the follow up period.
About 200 athletes who regulary participate in TeamGym training (at least once per week) and understand written and spoken Swedish will be included in this study.
Athletes with a recent injury to the foot, ankle, or lower leg or the presence of with other injuries to the lower limb or spine that may be accentuated or affect test results will be excluded.
Data regarding numbers of new injuries (acute and overuse injuries) in the foot, ankle and/or lower leg within six months after baseline testing aswell as severity score of the overuse injuries will be measured bi-weekly with the Oslo Sports Trauma Research Center (OSTRC) questionnaire.
- Conditions
- Ankle Injuries, Foot Injury, Overuse Injury, Ankle Sprains
- Keywords
- Gymnastics, TeamGym, Muscular Fatigue, Muscular Endurance
- Medical subject headings
- Ankle Injuries, Foot Injuries, Cumulative Trauma Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
New injury
Number of new acute/overuse injuries in the foot, ankle or lower leg.
Measured: Within six months after baseline testing.
Secondary outcomes (1)
Severity of overuse injury
Answers from 4 questions regarding severity are scored from 0 to 25, and summed to calculate a severity score between 0 (= no problems) and 100 (= maximum level of problems).
Measured: Bi-weekly follow-ups over a 6 month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start30 Apr 2022
- Primary completion16 Sep 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Beischer
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor-investigator, Susanne Beischer, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323773
- Sponsor's protocol ID
- Projektfot1
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: One of the purposes of the project is describing normative data regarding muscular endurance and hop performance in TeamGym athletes and the results will therefore be published. Thus, there will be no need to make IPD available for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How is Calf Muscle Endurance Related to Ankle Injuries in TeamGym Athletes?
- ClinicalTrials.gov ID
- NCT05323773
- Acronym / sponsor ID
- Projektfot1
- Conditions
- Ankle Injuries, Foot Injury, Overuse Injury, Ankle Sprains
- Keywords
- Gymnastics, TeamGym, Muscular Fatigue, Muscular Endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Susanne BeischerUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 12 Apr 2022 (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 specific aims of this study are to:
- describe how many heel raises and side hops TG athletes of various ages can perform and how far they can jump, one leg at a time.
- examine how calf muscle endurance and hop performance are related to the risk of new injuries in the foot, ankle, and lower leg in TG athletes.
The investigators hypothesise that atletes with superior performance in the tests for muscular endurance and hop performance will report fewer injuries during the follow up period.
Detailed description
TeamGym (TG) is the most common gymnastics discipline in Sweden. There is a relatively high injury incidence of 2,2-3,4 injuries per 1000 hours of gymnastic activity. Muscular fatigue has been proposed as a risk factor for sustaining an injury in gymnastics, but this has yet not been examined.
In TG, the lower extremity is more susceptible to injuries than the spine and upper extremity, with injury rates ranging between 60 - 77% for the lower extremity. More specifically, the foot, ankle, and the lower leg account for 40 - 56% of all reported injuries, consisting mostly of ankle injuries.
In clinical and research settings, heel raises and side hops are commonly used to assess muscular endurance in the lower leg. Furthermore, it is common to also include a hop performance test to assess the physical capacity of an athlete following an injury to the foot, ankle, or lower leg. However, there are normative values published of the aforementioned tests, in TG athletes
The overall purpose of this project is to facilitate and improve the caretaking of TG athletes who have sustained various types of injuries in the foot, ankle and lower leg.
Specific aims are to:
- describe how many heel raises and side hops TG athletes of various ages can perform and how far they can jump, one leg at a time.
- examine how calf muscle endurance and hop performance are related to the risk of new injuries in the foot, ankle, and lower leg in TG athletes.
The investigatorshypothesise that atletes with superior performance in the tests for muscular endurance and hop performance will report fewer injuries during the follow up period.
About 200 athletes who regulary participate in TeamGym training (at least once per week) and understand written and spoken Swedish will be included in this study.
Athletes with a recent injury to the foot, ankle, or lower leg or the presence of with other injuries to the lower limb or spine that may be accentuated or affect test results will be excluded.
Data regarding numbers of new injuries (acute and overuse injuries) in the foot, ankle and/or lower leg within six months after baseline testing aswell as severity score of the overuse injuries will be measured bi-weekly with the Oslo Sports Trauma Research Center (OSTRC) questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TeamGym athletes (members of the Swedish Gymnastics Federation) in Gothenburg, Sweden.
Key inclusion criteria (2 listed)
- Regular participation in TeamGym training (at least once per week)
- Understanding written and spoken Swedish
Key exclusion criteria (2 listed)
- Recent (defined as: in the last 4 weeks before baseline testing) injury to the foot, ankle, or lower leg = exclusion from hop tests.
- Presence of other injuries to the lower limb or spine that may be accentuated or affect test results.
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
New injury
Time frame: Within six months after baseline testing.
Number of new acute/overuse injuries in the foot, ankle or lower leg.
1 secondary outcome
Severity of overuse injury
Time frame: Bi-weekly follow-ups over a 6 month period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No. One of the purposes of the project is describing normative data regarding muscular endurance and hop performance in TeamGym athletes and the results will therefore be published. Thus, there will be no need to make IPD available for other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ankle Injuries and Foot Injury, run by Susanne Beischer 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 2 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New injury (time frame: Within six months after baseline testing.). 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 28 Feb 2024.