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System Dynamics Model for Acute Non-contact Lower Extremity Injuries Prediction

Study acronym: SDLE
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study completion date: Jul 2025 to Jul 2027v7
  2. Minor Study completion date: Jun 2024 to Jul 2025v6
  3. Minor Primary completion date changed from estimate of Jun 2023 to Jul 30, 2023v5
  4. Notable Primary endpoints revised (9)v4
  5. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 99
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2022 to Jul 22, 2022
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Despite the extensive research on prevention and prediction strategies, hamstrings strains injury (HSI) persists at a high rate in team sports and specifically in football. An initial injury increases the risk for re-injury and affects performance, whereas the financial cost for athletes and teams is crucial due to the time needed for appropriate rehabilitation. For that reason, it is critical to formulate better strategies in order to predict and prevent HSI. This study aims to develop a system dynamics (SD) model to evaluate HSI risk. First, a literature review will be carried out on the current approaches and identification of intrinsic and extrinsic risk factors of hamstrings strain injuries. Second, co-creation workshops based on the method of Group Modeling Building (GMB) will be applied to develop the SD for the HSI model. This co-creation process will involve stakeholders such as sports physiotherapists, doctors, and sports scientists. After creating the SD for HSI model, a one-year prospective cohort study will be performed to validate the model with real data and evaluate the ability of the model to predict HSIs. Sports teams will be invited to take part in the validation of the model. Multiple biomechanical parameters and other personal characteristics will be collected. Then, athletes will be monitored for the occurrence of injury and their exposure to injury risk during training and games. The factors' non-linear interaction will be assessed with the statistical method of structural equation modeling and factor analysis. In this way, the factors' interactions extracted for the qualitative phase of the study (group modeling building process) will be quantitatively evaluated. Validating the model with real data will provide a computer simulation platform to test plausible strategies for preventing hamstrings strain injuries prior to implementation and optimize intervention programs.
Trial Details
NCT Number NCT05425303
Lead Sponsor University of Patras
Conditions
(from sponsor)
Sport Injury, Hamstring Injury, Risk Factors, Interaction
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov