Sport InjuryNCT05430581
Prediction of Knee Injuries Through System Dynamics Modeling
An observational study of Sport Injury and Sports Physical Therapy, run by University of Patras at 1 site in Greece.
Trial summary
The large number of studies in the recent decade dealing with knee injury prevention seems not effective enough to cause a decline in knee injury rates. Thus, it has been proposed to use non-linear mathematical models that simulate the operation of complex and dynamic systems. Read more about this study
- Who is it for?
- Ages 17 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Sports Physical Therapy
- How many people
- 99 participants
- Where
- 1 siteGreece
- Study dates
- 22 Jul 2022to 31 Dec 2024
- 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 17 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: 100 healthy athletes (17-40 years old) that participate in sports that include activities such as jumping, slowing down, and change of direction by pivoting such as football, basketball, and handball
Who may be able to join
- Healthy professional athletes that participate in team sports (football, handball, basketball)
Who cannot join
- Injured athletes
Trial locations and contacts
1 site in 1 country.
About this study
The large number of studies in the recent decade dealing with knee injury prevention seems not effective enough to cause a decline in knee injury rates. Thus, it has been proposed to use non-linear mathematical models that simulate the operation of complex and dynamic systems.
The present study aims to analyze the dynamic relationships of the risk factors for knee injuries through system dynamics modeling to effectively predict and prevent knee injury. The first part of this project includes a qualitative study informing the theoretical non-linear interrelationships among the risk factors. The aim is to examine the initial hypothetical model formulated in the first part of the project through statistical analysis such as factor analysis and structural equation modeling. Pre-season and in-season data from questionnaires and biomechanical measurements for risk factors will be collected from at least 100 athletes who participate in high-risk sports. The athletes will be monitored for injuries during one season, and these data will be used in the next part of the research plan. The next part of the project aims to develop a dynamic simulation model for predicting knee injuries using specific equations. The function of the simulation model will predict the propensity of knee injuries over time. The next step includes the validation and calibration of the model based on the knee injuries that occurred during the season. The validated and calibrated model will then provide implications for effective policy decisions in knee injury prevention.
Read the detailed description
Although a large number of studies in the recent decade deal with the understanding of the risk factors and the improvement of injury prevention programs, the occurrence of knee injuries remains high. As a result, many studies recognize that sports injuries such as knee ACL injury is the result of a complex interaction of multiple risk factors which are interconnected in a non-linear way. Given the approaches to understanding the etiology of knee injuries so far, in most cases, some risk factors are examined and linked linearly to an injury. These approaches are useful enough to show the linear relationship between a particular risk factor and an injury, however, they fail to present the overall picture and dynamic interaction of the coexisting risk factors of an injury. Thus, in recent years, it has been proposed to use non-linear mathematical model that simulates the operation of complex and dynamic systems, with the ultimate goal of better understanding the dynamic interaction of various risk factors and improving prevention programs. Simulation modeling is considered to be a wise option because the complexities of problems are far beyond our capability to solve them manually. Simulation methods can be categorized into four main groups: Monte Carlo, discrete-event simulation, system dynamics, and agent-based simulation. Each group has its benefits regarding the topic examined. System dynamic modeling has been found useful in epidemic modeling and disease prevention strategies but to our knowledge has not yet been used in sports injury prevention topics. Therefore, the present study aims to analyze the captured dynamics of the risk factors for knee injuries through system dynamic modeling.
A better understanding of the intercorrelations among existing risk factors that contribute to knee injuries will be achieved through system dynamic methodology. Further, factors of comparable significance in injury prevention will be revealed. The use of system dynamics modeling in the field of sports injury prevention has not been incorporated into research methodology yet. This project will be the first attempt to capture the causal relationships among key risk factors for a knee injury and their dynamic interplay over time through system dynamic modeling. The developed dynamics model can be used to predict knee injuries and plan effective injury prevention programs.
SD modeling can be developed following specific tasks, including a clear explanation of the problem, generating a qualitative diagram of the system structure, converting the qualitative hypothesis to a quantitated simulation model, testing model, and informing policy decisions about model's implications.
The methodological procedure in this research project can be separated into three consecutive parts. The first part is a qualitive study that will inform about the theoretical non-linear interrelationships among the risk factors. The first step of the qualitative study is a comprehensive literature review to make a list of factors affecting knee injury among athletes and develop hypotheses about their interrelationships. Then, a Causal Loop Diagram (CLD) will be formulated based on the information extracted from the literature review and the application of group modelling building methodology. By this methodology experts in the field of sports injuries (this could be the modeling team) and stakeholders (sports scientists, doctors, other medical experts, coaches, trainers) will engaged in the modelling process based on a series of script workshops.
Specifically, the methodology of group modelling building is based on specific script exercises. More precisely, initially the reviewer will formulate a first perception of the causal relationships among the factors and a first overview of the Causal Loop Diagram. Afterwards, the modeling team will be incorporated in the modelling process. Approximately four series will be conducted for the formulation of the CLD. Then the CLD will be presented to main stakeholders selected by modeling team so as to engage their opinions about the CLD. Their opinions will be used to update the model. Then, the final casual diagram will be formulated.
The second part of the research project the object will be to quantify the interrelationships among factors using a structural equation model approach (SEM). Preseason and in-season data from 100 athletes will be collected using questionnaires and laboratory measurements that have been widely used in knee injury prediction surveys Structural equation modeling is a set of statistical techniques used to measure the complex relationships among variables to test the validity of theory using real data. It is similar but more powerful than regression analyses as it can investigate multiple hypothesized relationships among variables simultaneously while multiple regression does not allow such a holistic modeling. SEM can include several integrated analytic techniques such as group variance comparisons associated with ANOVA as well as regression analysis. Factor analysis is another special case of SEM whereby unobserved variables (factor or latent variables) are calculated from measured variables. In this way, SEM allows researchers to explain the development of phenomena such as diseases or injuries. The athletes will be monitored for injuries during one season and these data will be used in the third part of the research plan as described below.
In the third part, based on findings of the two previous studies described above, a dynamic simulation model for the prediction of knee injuries will be developed. The already collected data from the previous steps and analysis will be used to develop the simulation model. Using specific equations, the function of the simulation model will predict the propensity of knee injuries. Based on the interaction among the variables expressed in the CLD a perception/prediction of the likelihood of knee injury will be provided. Furthermore, through the model it would be able to see the changes in the variable of interest that is knee injuries if testist to alter the values of a variable.
The last step includes the validation and calibration of the model. The aim of this step is to test how close the estimation for knee injuries of the model were to the incidence of knee injuries occurred during the season.
It is expected that the members of sports medicine community use the results of the study to predict knee injuries and gain insight of the key risk factors, as well as their interrelationships and effectively plan injury prevention programs and strategies
- Conditions
- Sport Injury, Sports Physical Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in landing error scoring system test
The landing technique of the athletes will be assessed using the test landing error scoring system. The LESS assesses the quality of movement during landing based on a 19-point continuous scale. A maximum score of 19 can be reached; the lower the score, the better the landing technique.
Measured: Baseline test
BMI (kg/m^2)
Measured: Baseline test
Leg length (cm)
Measured: Baseline test
Tibia length (cm)
Measured: Baseline test
Demographic, history of injury, and activity level
Using questionnaires data will be collected regarding the age, level of competition, details of previous injuries, playing position, training volume
Measured: Baseline test
Passive range of motion with Goniometer
It will be assessed the range of motion for the following movements: Hip external/internal rotation, knee hyperextension, and ankle dorsiflexion
Measured: Baseline test
Core muscle endurance
It will be measured the time in seconds until exhaustion to maintain the position in the following tests: side bridge test, prone bridge test, extensor endurance test
Measured: Baseline test
Muscle strength
Muscle strength examination with hand held dynamometer for the following muscles: quadriceps, hamstrings and hip abductors
Measured: Baseline test
Balance
Assessment of the balance with the pressure platform during the task of single leg drop jump
Measured: Baseline test
Muscle activation
Assessment of quadriceps and hamstrings muscle activation with surface electromyography in the single leg hop for distance
Measured: Baseline test
Incidence of knee injuries
Collection data through questionnaire for knee injuries of the athletes during the season that cause at least one-day time loss from game or training
Measured: 1 year
Secondary outcomes (1)
Incidence of other lower extremity injuries
Collection data through questionnaire for other lower limb injuries of the athletes during the season that cause at least one-day time loss from game or training
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start22 Jul 2022
- Primary completion22 May 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sport 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charis Tsarbou, University of Patras
- Investigators
- Sofia A. Xergia, Study director, University of PatrasElias Tsepis, Study director, University of PatrasKonstantinos Fousekis, Study director, University of PatrasCharis Tsarbou, Principal investigator, University of PatrasGeorge Papageorgiou, Study director, European University CyprusNikolaos I. Liveris, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430581
- Sponsor's protocol ID
- 12756
- Status last verified
- Dec 2023
- First submitted
- 15 Jun 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fonseca ST, Souza TR, Verhagen E, van Emmerik R, Bittencourt NFN, Mendonca LDM, Andrade AGP, Resende RA, Ocarino JM. Sports Injury Forecasting and Complexity: A Synergetic Approach. Sports Med. 2020 Oct;50(10):1757-1770. doi: 10.1007/s40279-020-01326-4.
PubMed 32757162Bittencourt NFN, Meeuwisse WH, Mendonca LD, Nettel-Aguirre A, Ocarino JM, Fonseca ST. Complex systems approach for sports injuries: moving from risk factor identification to injury pattern recognition-narrative review and new concept. Br J Sports Med. 2016 Nov;50(21):1309-1314. doi: 10.1136/bjsports-2015-095850. Epub 2016 Jul 21.
PubMed 27445362Hulme A, Thompson J, Nielsen RO, Read GJM, Salmon PM. Towards a complex systems approach in sports injury research: simulating running-related injury development with agent-based modelling. Br J Sports Med. 2019 May;53(9):560-569. doi: 10.1136/bjsports-2017-098871. Epub 2018 Jun 18.
PubMed 29915127
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Knee Injuries Through System Dynamics Modeling
- ClinicalTrials.gov ID
- NCT05430581
- Acronym / sponsor ID
- 12756
- Conditions
- Sport Injury, Sports Physical Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 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 large number of studies in the recent decade dealing with knee injury prevention seems not effective enough to cause a decline in knee injury rates. Thus, it has been proposed to use non-linear mathematical models that simulate the operation of complex and dynamic systems.
The present study aims to analyze the dynamic relationships of the risk factors for knee injuries through system dynamics modeling to effectively predict and prevent knee injury. The first part of this project includes a qualitative study informing the theoretical non-linear interrelationships among the risk factors. The aim is to examine the initial hypothetical model formulated in the first part of the project through statistical analysis such as factor analysis and structural equation modeling. Pre-season and in-season data from questionnaires and biomechanical measurements for risk factors will be collected from at least 100 athletes who participate in high-risk sports. The athletes will be monitored for injuries during one season, and these data will be used in the next part of the research plan. The next part of the project aims to develop a dynamic simulation model for predicting knee injuries using specific equations. The function of the simulation model will predict the propensity of knee injuries over time. The next step includes the validation and calibration of the model based on the knee injuries that occurred during the season. The validated and calibrated model will then provide implications for effective policy decisions in knee injury prevention.
Detailed description
Although a large number of studies in the recent decade deal with the understanding of the risk factors and the improvement of injury prevention programs, the occurrence of knee injuries remains high. As a result, many studies recognize that sports injuries such as knee ACL injury is the result of a complex interaction of multiple risk factors which are interconnected in a non-linear way. Given the approaches to understanding the etiology of knee injuries so far, in most cases, some risk factors are examined and linked linearly to an injury. These approaches are useful enough to show the linear relationship between a particular risk factor and an injury, however, they fail to present the overall picture and dynamic interaction of the coexisting risk factors of an injury. Thus, in recent years, it has been proposed to use non-linear mathematical model that simulates the operation of complex and dynamic systems, with the ultimate goal of better understanding the dynamic interaction of various risk factors and improving prevention programs. Simulation modeling is considered to be a wise option because the complexities of problems are far beyond our capability to solve them manually. Simulation methods can be categorized into four main groups: Monte Carlo, discrete-event simulation, system dynamics, and agent-based simulation. Each group has its benefits regarding the topic examined. System dynamic modeling has been found useful in epidemic modeling and disease prevention strategies but to our knowledge has not yet been used in sports injury prevention topics. Therefore, the present study aims to analyze the captured dynamics of the risk factors for knee injuries through system dynamic modeling.
A better understanding of the intercorrelations among existing risk factors that contribute to knee injuries will be achieved through system dynamic methodology. Further, factors of comparable significance in injury prevention will be revealed. The use of system dynamics modeling in the field of sports injury prevention has not been incorporated into research methodology yet. This project will be the first attempt to capture the causal relationships among key risk factors for a knee injury and their dynamic interplay over time through system dynamic modeling. The developed dynamics model can be used to predict knee injuries and plan effective injury prevention programs.
SD modeling can be developed following specific tasks, including a clear explanation of the problem, generating a qualitative diagram of the system structure, converting the qualitative hypothesis to a quantitated simulation model, testing model, and informing policy decisions about model's implications.
The methodological procedure in this research project can be separated into three consecutive parts. The first part is a qualitive study that will inform about the theoretical non-linear interrelationships among the risk factors. The first step of the qualitative study is a comprehensive literature review to make a list of factors affecting knee injury among athletes and develop hypotheses about their interrelationships. Then, a Causal Loop Diagram (CLD) will be formulated based on the information extracted from the literature review and the application of group modelling building methodology. By this methodology experts in the field of sports injuries (this could be the modeling team) and stakeholders (sports scientists, doctors, other medical experts, coaches, trainers) will engaged in the modelling process based on a series of script workshops.
Specifically, the methodology of group modelling building is based on specific script exercises. More precisely, initially the reviewer will formulate a first perception of the causal relationships among the factors and a first overview of the Causal Loop Diagram. Afterwards, the modeling team will be incorporated in the modelling process. Approximately four series will be conducted for the formulation of the CLD. Then the CLD will be presented to main stakeholders selected by modeling team so as to engage their opinions about the CLD. Their opinions will be used to update the model. Then, the final casual diagram will be formulated.
The second part of the research project the object will be to quantify the interrelationships among factors using a structural equation model approach (SEM). Preseason and in-season data from 100 athletes will be collected using questionnaires and laboratory measurements that have been widely used in knee injury prediction surveys Structural equation modeling is a set of statistical techniques used to measure the complex relationships among variables to test the validity of theory using real data. It is similar but more powerful than regression analyses as it can investigate multiple hypothesized relationships among variables simultaneously while multiple regression does not allow such a holistic modeling. SEM can include several integrated analytic techniques such as group variance comparisons associated with ANOVA as well as regression analysis. Factor analysis is another special case of SEM whereby unobserved variables (factor or latent variables) are calculated from measured variables. In this way, SEM allows researchers to explain the development of phenomena such as diseases or injuries. The athletes will be monitored for injuries during one season and these data will be used in the third part of the research plan as described below.
In the third part, based on findings of the two previous studies described above, a dynamic simulation model for the prediction of knee injuries will be developed. The already collected data from the previous steps and analysis will be used to develop the simulation model. Using specific equations, the function of the simulation model will predict the propensity of knee injuries. Based on the interaction among the variables expressed in the CLD a perception/prediction of the likelihood of knee injury will be provided. Furthermore, through the model it would be able to see the changes in the variable of interest that is knee injuries if testist to alter the values of a variable.
The last step includes the validation and calibration of the model. The aim of this step is to test how close the estimation for knee injuries of the model were to the incidence of knee injuries occurred during the season.
It is expected that the members of sports medicine community use the results of the study to predict knee injuries and gain insight of the key risk factors, as well as their interrelationships and effectively plan injury prevention programs and strategies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 100 healthy athletes (17-40 years old) that participate in sports that include activities such as jumping, slowing down, and change of direction by pivoting such as football, basketball, and handball
Key inclusion criteria (1 listed)
- Healthy professional athletes that participate in team sports (football, handball, basketball)
Key exclusion criteria (1 listed)
- Injured athletes
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
Score in landing error scoring system test
Time frame: Baseline test
The landing technique of the athletes will be assessed using the test landing error scoring system. The LESS assesses the quality of movement during landing based on a 19-point continuous scale. A maximum score of 19 can be reached; the lower the score, the better the landing technique.
BMI (kg/m^2)
Time frame: Baseline test
Leg length (cm)
Time frame: Baseline test
Tibia length (cm)
Time frame: Baseline test
Demographic, history of injury, and activity level
Time frame: Baseline test
Using questionnaires data will be collected regarding the age, level of competition, details of previous injuries, playing position, training volume
Passive range of motion with Goniometer
Time frame: Baseline test
It will be assessed the range of motion for the following movements: Hip external/internal rotation, knee hyperextension, and ankle dorsiflexion
Core muscle endurance
Time frame: Baseline test
It will be measured the time in seconds until exhaustion to maintain the position in the following tests: side bridge test, prone bridge test, extensor endurance test
Muscle strength
Time frame: Baseline test
Muscle strength examination with hand held dynamometer for the following muscles: quadriceps, hamstrings and hip abductors
Balance
Time frame: Baseline test
Assessment of the balance with the pressure platform during the task of single leg drop jump
Muscle activation
Time frame: Baseline test
Assessment of quadriceps and hamstrings muscle activation with surface electromyography in the single leg hop for distance
Incidence of knee injuries
Time frame: 1 year
Collection data through questionnaire for knee injuries of the athletes during the season that cause at least one-day time loss from game or training
1 secondary outcome
Incidence of other lower extremity injuries
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 32757162Fonseca ST, Souza TR, Verhagen E, van Emmerik R, Bittencourt NFN, Mendonca LDM, Andrade AGP, Resende RA, Ocarino JM. Sports Injury Forecasting and Complexity: A Synergetic Approach. Sports Med. 2020 Oct;50(10):1757-1770. doi: 10.1007/s40279-020-01326-4.
- Background: PubMed 27445362Bittencourt NFN, Meeuwisse WH, Mendonca LD, Nettel-Aguirre A, Ocarino JM, Fonseca ST. Complex systems approach for sports injuries: moving from risk factor identification to injury pattern recognition-narrative review and new concept. Br J Sports Med. 2016 Nov;50(21):1309-1314. doi: 10.1136/bjsports-2015-095850. Epub 2016 Jul 21.
- Background: PubMed 29915127Hulme A, Thompson J, Nielsen RO, Read GJM, Salmon PM. Towards a complex systems approach in sports injury research: simulating running-related injury development with agent-based modelling. Br J Sports Med. 2019 May;53(9):560-569. doi: 10.1136/bjsports-2017-098871. Epub 2018 Jun 18.
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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 A. Xergia study director
University of Patras
Elias Tsepis study director
University of Patras
Konstantinos Fousekis study director
University of Patras
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 Sport Injury and Sports Physical Therapy, run by University of Patras at 1 site in Greece.
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 1 inclusion and 1 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 20 Dec 2023. 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 Greece. 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?
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?
Score in landing error scoring system test (time frame: Baseline test). The study lists 11 primary outcomes in all. 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 NCT05430581, which also lists 3 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 20 Dec 2023.