Optimisation of Performance and Avoidance of InjuryNCT02554461
Optimization of Movement Patterns in Elite Volleyball Players
An observational study of Optimisation of Performance and Avoidance of Injury, run by Prof. Dr. F. Staes at 1 site in Belgium.
Trial summary
On the basis of clinical and movement analysis records players are informed on what parameters can be optimized in order to improve their performance and avoid injuries Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optimisation of Performance and Avoidance of Injury
- What is being tested?
- advise for exercices given by team staff
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2015to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female national team volleyball players
Who may be able to join
- Members of national volleyball team signing informed consent
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimaliseren Van Lichaams- en Bewegingsspecifieke Kenmerken Bij Volleybalspelers Met Het Oog op Het Reduceren Van Blessures
On the basis of clinical and movement analysis records players are informed on what parameters can be optimized in order to improve their performance and avoid injuries
- Being tested
- advise for exercices given by team staff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advise for exercices given by team staffOther
To respond to questions asked:
it is not the investigator who decides on the intervention, but the daily team staff (e.g. trainer, coach, PT,.....). So no predetermined intervention is provided
| Study group | Role | What they receive |
|---|---|---|
| female players | national team players Receives: Other: advise for exercices given by team staff | |
| male players | national team players Receives: Other: advise for exercices given by team staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D and 3D joint angles of different movements together with kinetics
kinematics and kinetics with regard to gait, running, jumping and arm movements. This means for example joint angles (measured by 3D motion analyses data, 2D measurement data) and kinetics (joint moments, pressure plate measurements) Time frames: these data will recorded by one measurement session. For information of clinicaltrials.gov (also other outcome measures): at this point it really is an observational study. It is a kind of "service project" for an elite athletes team. Advice is provided, but not as is meant within a real clinical trial. It might evolve to such a project, but at this state it is not the case.
Measured: 1 day
Secondary outcomes (9)
muscle strength
isokinetic measurements (expressed in Nm)
Measured: 1 day
muscle strength
isokinetic measurements (ratio agonist/antagonist as for example ratio between knee flexors/extensors) Time frames: these data will be recorded during one measurement session. This is during same session as for primary outcome measure.
Measured: 1 day
joint stability
nominal scale (good, poor)
Measured: 1 day
joint control
nominal scale (good, poor)
Measured: 1 day
prevalence injury past
interview (frequency/percentage of occurrence)
Measured: 1 day
prevalence injury present
interview (yes/no)
Measured: 1 day
(segmental) length
Meter
Measured: 1 day
weight
Kg
Measured: 1 day
Body mass index
Kg/m²
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimisation of Performance and Avoidance of 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. F. Staes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. F. Staes, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Filip f Staes, prof, Principal investigator, UZLeuven - KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554461
- Sponsor's protocol ID
- S56955
- Status last verified
- Oct 2016
- First submitted
- 16 Sep 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimaliseren Van Lichaams- en Bewegingsspecifieke Kenmerken Bij Volleybalspelers Met Het Oog op Het Reduceren Van Blessures
- ClinicalTrials.gov ID
- NCT02554461
- Acronym / sponsor ID
- S56955
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Prof. Dr. F. StaesUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
On the basis of clinical and movement analysis records players are informed on what parameters can be optimized in order to improve their performance and avoid injuries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female players | – | Other: advise for exercices given by team staffnational team players |
| male players | – | Other: advise for exercices given by team staffnational team players |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female national team volleyball players
Key inclusion criteria (1 listed)
- Members of national volleyball team signing informed consent
Key exclusion criteria (1 listed)
- No specific exclusion criteria
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 |
|---|---|---|
| advise for exercices given by team staffTo respond to questions asked: it is not the investigator who decides on the intervention, but the daily team staff (e.g. trainer, coach, PT,.....). So no predetermined intervention is provided | Other | female players, male players |
Primary outcome
2D and 3D joint angles of different movements together with kinetics
Time frame: 1 day
kinematics and kinetics with regard to gait, running, jumping and arm movements. This means for example joint angles (measured by 3D motion analyses data, 2D measurement data) and kinetics (joint moments, pressure plate measurements) Time frames: these data will recorded by one measurement session. For information of clinicaltrials.gov (also other outcome measures): at this point it really is an observational study. It is a kind of "service project" for an elite athletes team. Advice is provided, but not as is meant within a real clinical trial. It might evolve to such a project, but at this state it is not the case.
9 secondary outcomes
muscle strength
Time frame: 1 day
muscle strength
Time frame: 1 day
joint stability
Time frame: 1 day
joint control
Time frame: 1 day
prevalence injury past
Time frame: 1 day
prevalence injury present
Time frame: 1 day
(segmental) length
Time frame: 1 day
weight
Time frame: 1 day
Body mass index
Time frame: 1 day
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 4 May 2017.
- Individual participant dataSharing planned: No
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.
Filip f Staes, prof principal investigator
UZLeuven - KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optimisation of Performance and Avoidance of Injury, run by Prof. Dr. F. Staes at 1 site in Belgium.
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: finished, as of the sponsor's last update on 4 May 2017. 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 Belgium. 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?
2D and 3D joint angles of different movements together with kinetics (time frame: 1 day). 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 4 May 2017.