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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Greece1 site
  • University of Patras

    Aigio, 25100

Other trials in Greece

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. BMI (kg/m^2)

    Measured: Baseline test

  3. Leg length (cm)

    Measured: Baseline test

  4. Tibia length (cm)

    Measured: Baseline test

  5. 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

  6. 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

  7. 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

  8. Muscle strength

    Muscle strength examination with hand held dynamometer for the following muscles: quadriceps, hamstrings and hip abductors

    Measured: Baseline test

  9. Balance

    Assessment of the balance with the pressure platform during the task of single leg drop jump

    Measured: Baseline test

  10. Muscle activation

    Assessment of quadriceps and hamstrings muscle activation with surface electromyography in the single leg hop for distance

    Measured: Baseline test

  11. 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)
  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.

  1. First posted24 Jun 2022
  2. Study start22 Jul 2022
  3. Primary completion22 May 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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 32757162
  • Bittencourt 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 27445362
  • Hulme 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

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.

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