LOWER-LIMB INJURYNCT04232527
Dynamic Balance, Flexibility and Agility as Predictors of Lower-extremity Injury in Football Players
An observational study of LOWER-LIMB INJURY, run by Dragan Mijatović at 1 site in Bosnia and Herzegovina.
Trial summary
This research investigates the reliability of tests to assess injury risk. Participants will be tested at the beginning of the survey and will be monitored for over 5 months. Participants will take 4 types of tests related to dynamic balance, flexibility, and agility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- LOWER-LIMB INJURY
- What is being tested?
- Y Balance Test, Sit and Reach Test and "Maximum Legs Abduction" Test
- How many people
- 110 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 20 Jan 2020to 26 Aug 2020
- 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 18 to 40 years
- Men only
- Adult
Study population: About 110 players (out of about 400 competing in the Premier League of Bosnia and Herzegovina) would be included in the research.
Who may be able to join
- Professional players
- Age above 18 years
- Voluntary access to research
Who cannot join
- Age under 18,
- Refusal to take the research,
- Remaining in the club until the end of the examination,
- Errors in keeping records of injuries by responsible persons,
- Injuries to the lower limbs in the last ten days,
- Vestibular disorders.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
NK "Široki Brijeg"
Siroki Brijeg, 88220
About this study
Official title: Prospective Cohort Study, Follow-up of Subjects Over Long Periods, Assessment of Test Reliability in Predicting Injury Risk
This research investigates the reliability of tests to assess injury risk. Participants will be tested at the beginning of the survey and will be monitored for over 5 months. Participants will take 4 types of tests related to dynamic balance, flexibility, and agility. Subsequently, the relationship between test results and the incidence of injury in the subjects will be analyzed. If the tests prove reliable, they will be included in standard tests to assess the risk of injury to football players.
Read the detailed description
Too often, injuring athlete results in a large amount of money being spent on rehabilitation. In a world of sports where the speed of recovery means a lot, ways are sought first and foremost to minimize the frequency of non-contact injuries. To prevent certain things, it is important to know the initial state, therefore, to see if certain factors at the outset indicate to us that there is a certain imbalance that can result in the injury. Since we live in a country where sports clubs are unable to spend large amounts of money on rehabilitation, it would be of great benefit to find reliable tests that can help to prevent an injury. Studies have shown that tests of balance, flexibility, and agility can help to prevent injury to football players in other countries. The same tests will be applied to Premier League footballers in Bosnia and Herzegovina and their effectiveness in assessing the degree of risk of lower limb injuries will be tested. If they prove reliable, they can become a standard in the prevention of these injuries, that is, they will help in the development of injury prevention programs, which would be of great benefit to both clubs and football players.
The study aims to determine whether dynamic balance and flexibility tests can be used as reliable predictors of lower limb injuries in football players and whether reduced agility influences the increased risk of injury.
- Conditions
- LOWER-LIMB INJURY
- Being tested
- Y Balance Test, Sit and Reach Test, "Maximum Legs Abduction" Test, S_RAG (reactive agility)" Test, S_CODS (change of direction speed) Test
- Keywords
- Dynamic balance, Stretching, Flexibility, Agility
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y Balance TestDiagnostic test
The footballer will place one foot on the stationary platform of the test set during the test so that the top of the sneaker does not exceed the starting line. The second foot, or the tip of the foot, will push the movable part of the platform down the measuring tube, which is marked by half-inch intervals. Any lifting of the standing leg on the heel, on the toes or loss of balance will be considered a mistake and the attempt will be repeated. Mobility will be tested through 3 trial and 3 valid measurements of the lower limbs in the anterior, posteromedial, and posterolateral directions. The arms should rest on the hips.
Sit and Reach TestDiagnostic test
This test involves sitting on the floor with your legs stretched straight forward. Shoes should be removed. The feet themselves are set straight against the box. Both knees must be stretched. With the palms facing down and the palms side-by-side or side-by-side, the subject approaches the measurement line as far as possible. It is important to keep your hands in the same position level, not that one reaches further than the other. Once the subject has reached the maximum distance, hold this position for one to two seconds and record the distance.
"Maximum Legs Abduction" TestDiagnostic test
Seated legs abduction is a test to assess the flexibility of the groin region. Respondent without the shoe sits with its back and head resting against the wall. As a sign, the subject extends the legs (stretches) to the maximum extent. During the test, the legs should not be bent at the knee joint.
S_RAG (reactive agility)" TestDiagnostic test
The test consist of fast-moving forward, and a change of direction conditioned by visual stimuli.
S_CODS (change of direction speed) TestDiagnostic test
S_CODS (change of direction speed) is a test that allows athletes to outperform their opponents in situations where they can pre-define a movement pattern.
| Study group | Role | What they receive |
|---|---|---|
| Professional Footballers | About 110 players (out of about 400 competing in the Premier League of Bosnia and Herzegovina) would be included in the research. Receives: Diagnostic Test: Y Balance Test; Diagnostic Test: Sit and Reach Test; Diagnostic Test: "Maximum Legs Abduction" Test; Diagnostic Test: S_RAG (reactive agility)" Test; Diagnostic Test: S_CODS (change of direction speed) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence
The main outcome measure is the incidence, that is, the number of newly injured players over almost five months.
Measured: 5 month
Secondary outcomes (7)
Questionnaire to evaluate the current situation with lower limb injuries in football players
It consists of 20 questions that ask about the condition of the lower limbs in tested football players.
Measured: 5 minutes
Y balance test
Mobility will be tested through 3 trial and 3 valid measurements of the lower limbs in the anterior, posteromedial, and posterolateral directions.
Measured: 15 minutes
Sit and Reach test
The Sit and Reach Test is a common muscle and lower back flexion test and is now widely used as a general flexibility test.
Measured: 5 minutes
Maximum legs abduction Test
A seat abduction test is a test to assess the flexibility of the groin regions. The footballer extends his legs as far as possible (stretches). The distance between the inner malleolus is measured in centimeters tape.
Measured: 5 minutes
S_RAG (reactive agility) Test
S_RAG (reactive agility) Test is emphasized when athletes perform a change of direction while responding to an external visual stimulus.
Measured: 10 minutes
Measuring the length of the legs
Anthropological measures will be taken (from the spin of the iliac anterior superior to the middle of the inner malleolus).
Measured: 2 minutes
S_CODS (change of direction speed) Test
S_CODS (change of direction speed) is a test that allows athletes to outperform their opponents in situations where they can pre-define a movement pattern.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020
- Primary completion15 Feb 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for LOWER-LIMB INJURYStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragan Mijatović
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dragan Mijatović, University of Mostar
- Investigators
- Damir Sekulić, PhD, Study chair, KIF Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232527
- Sponsor's protocol ID
- DMijatovic
- Status last verified
- Aug 2020
- First submitted
- 14 Jan 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jones BH, Cowan DN, Tomlinson JP, Robinson JR, Polly DW, Frykman PN. Epidemiology of injuries associated with physical training among young men in the army. Med Sci Sports Exerc. 1993 Feb;25(2):197-203.
PubMed 8450721van Mechelen W. Running injuries. A review of the epidemiological literature. Sports Med. 1992 Nov;14(5):320-35. doi: 10.2165/00007256-199214050-00004.
PubMed 1439399Kinzey SJ, Armstrong CW. The reliability of the star-excursion test in assessing dynamic balance. J Orthop Sports Phys Ther. 1998 May;27(5):356-60. doi: 10.2519/jospt.1998.27.5.356.
PubMed 9580895Greenberg ET, Barle M, Glassmann E, Jung MK. INTERRATER AND TEST-RETEST RELIABILITY OF THE Y BALANCE TEST IN HEALTHY, EARLY ADOLESCENT FEMALE ATHLETES. Int J Sports Phys Ther. 2019 Apr;14(2):204-213.
PubMed 30997273Lee SK, Ahn SH. Effects of balance evaluation comparison of dynamic balance and Y balance. J Exerc Rehabil. 2018 Dec 27;14(6):939-943. doi: 10.12965/jer.1836494.247. eCollection 2018 Dec.
PubMed 30656152Sheppard JM, Young WB. Agility literature review: classifications, training and testing. J Sports Sci. 2006 Sep;24(9):919-32. doi: 10.1080/02640410500457109.
PubMed 16882626Sekulic D, Spasic M, Mirkov D, Cavar M, Sattler T. Gender-specific influences of balance, speed, and power on agility performance. J Strength Cond Res. 2013 Mar;27(3):802-11. doi: 10.1519/JSC.0b013e31825c2cb0.
PubMed 22580982Brunner R, Friesenbichler B, Casartelli NC, Bizzini M, Maffiuletti NA, Niedermann K. Effectiveness of multicomponent lower extremity injury prevention programmes in team-sport athletes: an umbrella review. Br J Sports Med. 2019 Mar;53(5):282-288. doi: 10.1136/bjsports-2017-098944. Epub 2018 Sep 10.
PubMed 30201793Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.
PubMed 18226664Sisic N, Jelicic M, Pehar M, Spasic M, Sekulic D. Agility performance in high-level junior basketball players: the predictive value of anthropometrics and power qualities. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):884-93. Epub 2015 May 5.
PubMed 25942016Kiesel K, Plisky P, Butler R. Functional movement test scores improve following a standardized off-season intervention program in professional football players. Scand J Med Sci Sports. 2011 Apr;21(2):287-92. doi: 10.1111/j.1600-0838.2009.01038.x.
PubMed 20030782Caraffa A, Cerulli G, Projetti M, Aisa G, Rizzo A. Prevention of anterior cruciate ligament injuries in soccer. A prospective controlled study of proprioceptive training. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):19-21. doi: 10.1007/BF01565992.
PubMed 8963746McGuine TA, Keene JS. The effect of a balance training program on the risk of ankle sprains in high school athletes. Am J Sports Med. 2006 Jul;34(7):1103-11. doi: 10.1177/0363546505284191. Epub 2006 Feb 13.
PubMed 16476915Lisman P, Nadelen M, Hildebrand E, Leppert K, de la Motte S. Functional movement screen and Y-Balance test scores across levels of American football players. Biol Sport. 2018 Sep;35(3):253-260. doi: 10.5114/biolsport.2018.77825. Epub 2018 Aug 27.
PubMed 30449943Wong TKK, Ma AWW, Liu KPY, Chung LMY, Bae YH, Fong SSM, Ganesan B, Wang HK. Balance control, agility, eye-hand coordination, and sport performance of amateur badminton players: A cross-sectional study. Medicine (Baltimore). 2019 Jan;98(2):e14134. doi: 10.1097/MD.0000000000014134.
PubMed 30633230
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study, Follow-up of Subjects Over Long Periods, Assessment of Test Reliability in Predicting Injury Risk
- ClinicalTrials.gov ID
- NCT04232527
- Acronym / sponsor ID
- DMijatovic
- Conditions
- LOWER-LIMB INJURY
- Keywords
- Dynamic balance, Stretching, Flexibility, Agility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Dragan MijatovićUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 18 Jan 2020 (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.
This research investigates the reliability of tests to assess injury risk. Participants will be tested at the beginning of the survey and will be monitored for over 5 months. Participants will take 4 types of tests related to dynamic balance, flexibility, and agility. Subsequently, the relationship between test results and the incidence of injury in the subjects will be analyzed. If the tests prove reliable, they will be included in standard tests to assess the risk of injury to football players.
Detailed description
Too often, injuring athlete results in a large amount of money being spent on rehabilitation. In a world of sports where the speed of recovery means a lot, ways are sought first and foremost to minimize the frequency of non-contact injuries. To prevent certain things, it is important to know the initial state, therefore, to see if certain factors at the outset indicate to us that there is a certain imbalance that can result in the injury. Since we live in a country where sports clubs are unable to spend large amounts of money on rehabilitation, it would be of great benefit to find reliable tests that can help to prevent an injury. Studies have shown that tests of balance, flexibility, and agility can help to prevent injury to football players in other countries. The same tests will be applied to Premier League footballers in Bosnia and Herzegovina and their effectiveness in assessing the degree of risk of lower limb injuries will be tested. If they prove reliable, they can become a standard in the prevention of these injuries, that is, they will help in the development of injury prevention programs, which would be of great benefit to both clubs and football players.
The study aims to determine whether dynamic balance and flexibility tests can be used as reliable predictors of lower limb injuries in football players and whether reduced agility influences the increased risk of injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Professional Footballers | – | Diagnostic Test: Y Balance Test, Diagnostic Test: Sit and Reach Test, Diagnostic Test: "Maximum Legs Abduction" Test, Diagnostic Test: S_RAG (reactive agility)" Test, Diagnostic Test: S_CODS (change of direction speed) TestAbout 110 players (out of about 400 competing in the Premier League of Bosnia and Herzegovina) would be included in the research. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- About 110 players (out of about 400 competing in the Premier League of Bosnia and Herzegovina) would be included in the research.
Key inclusion criteria (3 listed)
- Professional players
- Age above 18 years
- Voluntary access to research
Key exclusion criteria (6 listed)
- Age under 18,
- Refusal to take the research,
- Remaining in the club until the end of the examination,
- Errors in keeping records of injuries by responsible persons,
- Injuries to the lower limbs in the last ten days,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y Balance TestThe footballer will place one foot on the stationary platform of the test set during the test so that the top of the sneaker does not exceed the starting line. The second foot, or the tip of the foot, will push the movable part of the platform down the measuring tube, which is marked by half-inch intervals. Any lifting of the standing leg on the heel, on the toes or loss of balance will be considered a mistake and the attempt will be repeated. Mobility will be tested through 3 trial and 3 valid measurements of the lower limbs in the anterior, posteromedial, and posterolateral directions. The arms should rest on the hips. | Diagnostic test | Professional Footballers |
| Sit and Reach TestThis test involves sitting on the floor with your legs stretched straight forward. Shoes should be removed. The feet themselves are set straight against the box. Both knees must be stretched. With the palms facing down and the palms side-by-side or side-by-side, the subject approaches the measurement line as far as possible. It is important to keep your hands in the same position level, not that one reaches further than the other. Once the subject has reached the maximum distance, hold this position for one to two seconds and record the distance. | Diagnostic test | Professional Footballers |
| "Maximum Legs Abduction" TestSeated legs abduction is a test to assess the flexibility of the groin region. Respondent without the shoe sits with its back and head resting against the wall. As a sign, the subject extends the legs (stretches) to the maximum extent. During the test, the legs should not be bent at the knee joint. | Diagnostic test | Professional Footballers |
| S_RAG (reactive agility)" TestThe test consist of fast-moving forward, and a change of direction conditioned by visual stimuli. | Diagnostic test | Professional Footballers |
| S_CODS (change of direction speed) TestS_CODS (change of direction speed) is a test that allows athletes to outperform their opponents in situations where they can pre-define a movement pattern. | Diagnostic test | Professional Footballers |
Primary outcome
The incidence
Time frame: 5 month
The main outcome measure is the incidence, that is, the number of newly injured players over almost five months.
7 secondary outcomes
Questionnaire to evaluate the current situation with lower limb injuries in football players
Time frame: 5 minutes
Y balance test
Time frame: 15 minutes
Sit and Reach test
Time frame: 5 minutes
Maximum legs abduction Test
Time frame: 5 minutes
S_RAG (reactive agility) Test
Time frame: 10 minutes
Measuring the length of the legs
Time frame: 2 minutes
S_CODS (change of direction speed) Test
Time frame: 2 minutes
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 Aug 2020.
- Background: PubMed 8450721Jones BH, Cowan DN, Tomlinson JP, Robinson JR, Polly DW, Frykman PN. Epidemiology of injuries associated with physical training among young men in the army. Med Sci Sports Exerc. 1993 Feb;25(2):197-203.
- Background: PubMed 1439399van Mechelen W. Running injuries. A review of the epidemiological literature. Sports Med. 1992 Nov;14(5):320-35. doi: 10.2165/00007256-199214050-00004.
- Background: PubMed 9580895Kinzey SJ, Armstrong CW. The reliability of the star-excursion test in assessing dynamic balance. J Orthop Sports Phys Ther. 1998 May;27(5):356-60. doi: 10.2519/jospt.1998.27.5.356.
- Background: PubMed 30997273Greenberg ET, Barle M, Glassmann E, Jung MK. INTERRATER AND TEST-RETEST RELIABILITY OF THE Y BALANCE TEST IN HEALTHY, EARLY ADOLESCENT FEMALE ATHLETES. Int J Sports Phys Ther. 2019 Apr;14(2):204-213.
- Background: PubMed 30656152Lee SK, Ahn SH. Effects of balance evaluation comparison of dynamic balance and Y balance. J Exerc Rehabil. 2018 Dec 27;14(6):939-943. doi: 10.12965/jer.1836494.247. eCollection 2018 Dec.
- Background: PubMed 16882626Sheppard JM, Young WB. Agility literature review: classifications, training and testing. J Sports Sci. 2006 Sep;24(9):919-32. doi: 10.1080/02640410500457109.
- Background: PubMed 22580982Sekulic D, Spasic M, Mirkov D, Cavar M, Sattler T. Gender-specific influences of balance, speed, and power on agility performance. J Strength Cond Res. 2013 Mar;27(3):802-11. doi: 10.1519/JSC.0b013e31825c2cb0.
- Background: PubMed 30201793Brunner R, Friesenbichler B, Casartelli NC, Bizzini M, Maffiuletti NA, Niedermann K. Effectiveness of multicomponent lower extremity injury prevention programmes in team-sport athletes: an umbrella review. Br J Sports Med. 2019 Mar;53(5):282-288. doi: 10.1136/bjsports-2017-098944. Epub 2018 Sep 10.
- Background: PubMed 18226664Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.
- Background: PubMed 25942016Sisic N, Jelicic M, Pehar M, Spasic M, Sekulic D. Agility performance in high-level junior basketball players: the predictive value of anthropometrics and power qualities. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):884-93. Epub 2015 May 5.
- Background: PubMed 20030782Kiesel K, Plisky P, Butler R. Functional movement test scores improve following a standardized off-season intervention program in professional football players. Scand J Med Sci Sports. 2011 Apr;21(2):287-92. doi: 10.1111/j.1600-0838.2009.01038.x.
- Background: PubMed 8963746Caraffa A, Cerulli G, Projetti M, Aisa G, Rizzo A. Prevention of anterior cruciate ligament injuries in soccer. A prospective controlled study of proprioceptive training. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):19-21. doi: 10.1007/BF01565992.
- Individual participant dataSharing planned: Undecided
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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.
Damir Sekulić, PhD study chair
KIF Split
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 LOWER-LIMB INJURY, run by Dragan Mijatović at 1 site in Bosnia and Herzegovina.
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 6 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 Aug 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 Bosnia and Herzegovina. 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?
The incidence (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232527, which also lists 16 linked publications.
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 Aug 2020.