NCT05430581

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

June 15, 2022

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (11)

  • 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.

    Baseline test

  • BMI (kg/m^2)

    Baseline test

  • Leg length (cm)

    Baseline test

  • Tibia length (cm)

    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

    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

    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

    Baseline test

  • Muscle strength

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

    Baseline test

  • Balance

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

    Baseline test

  • Muscle activation

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

    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

    1 year

Secondary Outcomes (1)

  • Incidence of other lower extremity injuries

    1 year

Eligibility Criteria

Age17 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • Healthy professional athletes that participate in team sports (football, handball, basketball)

You may not qualify if:

  • Injured athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Patras

Aigio, 25100, Greece

Location

Related Publications (3)

  • 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.

    PMID: 32757162BACKGROUND
  • 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.

    PMID: 27445362BACKGROUND
  • 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.

    PMID: 29915127BACKGROUND

Study Officials

  • Sofia A. Xergia

    University of Patras

    STUDY DIRECTOR
  • Elias Tsepis

    University of Patras

    STUDY DIRECTOR
  • Konstantinos Fousekis

    University of Patras

    STUDY DIRECTOR
  • Charis Tsarbou

    University of Patras

    PRINCIPAL INVESTIGATOR
  • George Papageorgiou

    European University Cyprus

    STUDY DIRECTOR
  • Nikolaos I. Liveris

    University of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 24, 2022

Study Start

July 22, 2022

Primary Completion

May 22, 2023

Study Completion

December 31, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations