Musculoskeletal InjuryTELASINCT03518827
Body Asymmetries in Athletes and Injury Risk
An observational study of Musculoskeletal Injury, run by University of Primorska at 2 sites in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Asymmetry measurement
- How many people
- 1,050 participants
- Where
- 2 sitesSlovenia
- Study dates
- 15 May 2018to 30 Aug 2021
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Athletes at a competitive level, coming from different sports.
Who may be able to join
- Included in competitive play
- Is a professional athlete or participates in organized professional sports activities
- Had a medical examination in previous year
Who cannot join
- Present injuries
- Recreational athletes
- Any other significant diseases
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
University of Primorska, Faculty of Health Sciences
Izola, 6310
University of Ljubljana, Faculty of Sport
Ljubljana, 1000
About this study
Official title: Retrospective and Prospective Analysis of Asymmetries as Injury Risk Factors in Different Athletes
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.
Read the detailed 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
- Conditions
- Musculoskeletal Injury
- Being tested
- Asymmetry measurement
- Keywords
- asymmetry, pain, sport, injury, risk factor
- Medical subject headings
- Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetry measurementOther
There is no intervention, the study will prospectively assess associations between asymmetries and injury risk. Asymmetry measurement will be conducted, then injuries will be tracked.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | For Asymmetry measurement, the group will consist of 200 athletes of different sports (the proportion not strictly predefined) - track and field, racket sports, ball sports, other team sports, swimming, running, cycling, dancing, ice skating, etc. Receives: Other: Asymmetry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury occurence
Injury occurrence in 1-year follow up
Measured: After 1-year
Secondary outcomes (5)
Strength asymmetries
Strength asymmetries between the opposing muscles or opposing limbs, measured by dynamometry
Measured: Baseline
Balance asymmetries
Balance asymmetries (body sway) in different type of stances, measured by bilateral force plates
Measured: Baseline
Flexibility asymmetries
Flexibility asymmetries between the opposing limbs (Range of Motion)
Measured: Baseline
Anthropometric asymmetries
Asymmetries in body segment lengths and girths
Measured: Baseline
Injury history
Injury occurrence in 1-year history
Measured: 1-year before the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start15 May 2018
- Primary completion30 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Jozef Stefan Institute
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Šarabon, PhD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518827
- Sponsor's protocol ID
- TELASI-PREVENT
- Acronym
- TELASI
- Status last verified
- Nov 2022
- First submitted
- 23 Apr 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Analysis of Asymmetries as Injury Risk Factors in Different Athletes
- ClinicalTrials.gov ID
- NCT03518827
- Acronym / sponsor ID
- TELASI / TELASI-PREVENT
- Conditions
- Musculoskeletal Injury
- Keywords
- asymmetry, pain, sport, injury, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Jozef Stefan Institute
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 8 May 2018 (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 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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | Other: Asymmetry measurementFor Asymmetry measurement, the group will consist of 200 athletes of different sports (the proportion not strictly predefined) - track and field, racket sports, ball sports, other team sports, swimming, running, cycling, dancing, ice skating, etc. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Athletes at a competitive level, coming from different sports.
Key inclusion criteria (3 listed)
- Included in competitive play
- Is a professional athlete or participates in organized professional sports activities
- Had a medical examination in previous year
Key exclusion criteria (3 listed)
- Present injuries
- Recreational athletes
- Any other significant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asymmetry measurementThere is no intervention, the study will prospectively assess associations between asymmetries and injury risk. Asymmetry measurement will be conducted, then injuries will be tracked. | Other | Athletes |
Primary outcome
Injury occurence
Time frame: After 1-year
Injury occurrence in 1-year follow up
5 secondary outcomes
Strength asymmetries
Time frame: Baseline
Balance asymmetries
Time frame: Baseline
Flexibility asymmetries
Time frame: Baseline
Anthropometric asymmetries
Time frame: Baseline
Injury history
Time frame: 1-year before the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Musculoskeletal Injury
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
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.
Nejc Šarabon, PhD principal investigator
University of Primorska, Faculty of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury, run by University of Primorska at 2 sites in Slovenia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Injury occurence (time frame: After 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.