Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03518827 |
Other study ID # |
TELASI-PREVENT |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 15, 2018 |
Est. completion date |
August 30, 2021 |
Study information
Verified date |
November 2022 |
Source |
University of Primorska |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The study will assess the associations between various asymmetries (strength, flexibility,
balance, etc.) in different athletes. After the measurements, injury occurrence will be
tracked prospectively for 1 year, and retrospective analysis will be performed as well. The
main aim of the study is to determine the asymmetries that impose the biggest injury risk for
athletes.
Description:
So far, the studies in the area of sport science have not thoroughly investigated the
interrelations between different types or levels of body asymmetries, or determined the
predictive power of asymmetries regarding injury risk. The conduction of this study will
produce several original outputs. In short, the participants will be assessed for body
asymmetries, and injury occurrence will be tracked both retrospectively and prospectively.
Participants:
- athletes of different sports (not predefined)
- not currently injured
- no non-communicable diseases
- participates in sport for at least 2 years
- participates in competitive play / matches
Test battery:
The first part of our test battery will include the measurements of the structural
irregularities. We will place a special emphasis on potential limb length discrepancy and
pelvic alignment in frontal plane. When a noticeable deviations are seen, additional
measurements of anthropometric characteristics will ensue.
The second part of the tests will be designed to assess the asymmetries in motor abilities
and function. The flexibility will be evaluated by assessing the passive range of motion in
individual joints, using an electronic goniometer. We will include all motions that are
performed in each joint (all major lower limb joints and trunk will be included). Each test
will be repeated three times, with the best result (highest range of motion) taken as a final
result.
The ability to maintain a still single-leg stance with open eyes will be measured to evaluate
static stability (main outcome parameters: velocity, amplitude and frequency of the centre of
pressure). The dynamic stability will be assessed using similar parameters, captured after
the landing on the force plate.
Maximal strength and explosive strength will be measured in isometric conditions on purposely
designed dynamometers. Maximal force and rates of force development on different time
intervals will be recorded. The measurements will include the ankle (flexion and extension),
the knee (flexion and extension), the hip (flexion, extension, abduction and abduction) and
the trunk (flexion, extension, lateral flexion). Additionally, the eccentric strength of the
knee flexors will be assessed.
The last part of the measurements will include kinematic and kinetic evaluation of complex
cyclic (cycling, running) and acyclic (jumps, landings) movement patterns. Lateral
asymmetries during cycling will be measured using a diagnostic tool that records the forces
and torques on the pedal, and by kinematics systems for tracking the motion of body regions.
The pedals record the behaviour of the pressure exerted on the pedals during cycling,
enabling us to evaluate the technique of the pedalling (mechanical efficiency) and amplitude
(power). The kinematic analysis track the motion of the body. Dynamic and kinematic
parameters are interrelated and often change simultaneously. Biomechanical properties
(kinematic and dynamic) of running and jumps/landings will be recorded with a full-body
motion capture solution that allows unconstrained movement of the subject and wireless
transmission of measured quantities. Based on the measured motion and the acquired ground
reaction forces, and the dynamic model of the human body, we will be able to calculate joint
torques.
Injury tracking:
- purpose-made questionnaires, including type, severity and recurrence of injury
- built based on previous questionnaires used in Sports Medicine
Main outcomes:
- Injury rates in 1-year follow up and 1-year history
- Odds ratios between groups, based on presence of asymmetries