InjuriesNCT03285009
Movement Patterns in Young Volleyball Athletes
A study testing Training intervention in people with Injuries and Training, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This project is a consequence of the research chair project studying the same phenomenon in adult volleyball players. The project will make use of and be part of the routine medical screening that is taken by the young players of the first degree of the Leuven Volleyball School, Belgium. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- What is being tested?
- Training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2017to 23 Dec 2018
- Phase
- Interventional
- 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 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All students from the first degree of the Volleyball school will participate
- Male and female athletes will be included
- Signing of an informed consent and assent form (for young kids) to use data for research
- Agreement given by the medical staff to use data and allowing the kids to be accepted by the school
Who cannot join
- When inclusion criteria are not met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Body and Movement Specific Characteristics in Volleyball Players to Reduces Injuries in Young Athletes.
This project is a consequence of the research chair project studying the same phenomenon in adult volleyball players. The project will make use of and be part of the routine medical screening that is taken by the young players of the first degree of the Leuven Volleyball School, Belgium. All young players must undergo a routine medical investigation and movement screening. This is obliged by the law. The current project will use these data. Outcome parameters will be used to advice the trainer staff of the school to adjust their training interventions. This is normal routine too as the involved medical department has been advising the school for many years. Players will be followed up for 6 weeks. After those 6 weeks, the movement screening will be repeated to evaluate the change in the different outcome parameters. This last screening is not part of a normal routine as players normally are investigated more in a subjective way. The medical team and school want to change that routine.
Data will be used to further improve training modalities and sports performance and reduce injury risk in these young athletes.
- Being tested
- Training intervention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training interventionOther
Based on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training.
Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school.
| Study group | Role | What they receive |
|---|---|---|
| Training intervention | Other | See information elsewhere Receives: Other: Training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of joint mobility
Mobility will be assessed by using goniometer measurements (degrees of movement)
Measured: Difference between baseline and 6 weeks
Change of strength
Strength will be assessed by using handheld dynamo-meter data (Newton)
Measured: Difference between baseline and 6 weeks
Change in balance score
Stability is measured using the score on the Star Excursion Balance Test (numeric score on balance scale)
Measured: Difference between baseline and 6 weeks
Change in lower limb joint angles during a single leg drop vertical jump
Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
Measured: Difference between baseline and 6 weeks
Change in lumbopelvic stability score
Lumbopelvic stability is scored using 9 clinical tests (Bend knee fall out, Active straight leg raise, prone knee bend, sitting knee extension, standing bow, pelvic tilt, one leg stance, backward rocking, forward rocking). Each test is given a score between 0 (poor performance) and 2 (good performance) adding up to a total score of 18.
Measured: Difference between baseline and 6 weeks
Change in lower limb joint angles during a drop jump
Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
Measured: Difference between baseline and 6 weeks
Secondary outcomes (2)
Individualized web diagram of all outcome measurements
Baseline data on joint mobility (joint angles), strength (N), balance (Star Excursion Balance Test Score, lumbopelvic control scores) and joint angles during a drop jump and single leg drop vertical jump) are all visualized on a web diagram per athlete
Measured: Baseline
Number of injuries
Description of number of injuries
Measured: Baseline information from medical investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start25 Sep 2017
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. F. Staes, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Filip F Staes, prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285009
- Sponsor's protocol ID
- S60760
- Status last verified
- Nov 2020
- First submitted
- 10 Sep 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared with other researchers. Data will be available to the medical and trainers staff. For research purposes, all data will be made anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Body and Movement Specific Characteristics in Volleyball Players to Reduces Injuries in Young Athletes.
- ClinicalTrials.gov ID
- NCT03285009
- Acronym / sponsor ID
- S60760
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 15 Sep 2017 (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.
This project is a consequence of the research chair project studying the same phenomenon in adult volleyball players. The project will make use of and be part of the routine medical screening that is taken by the young players of the first degree of the Leuven Volleyball School, Belgium. All young players must undergo a routine medical investigation and movement screening. This is obliged by the law. The current project will use these data. Outcome parameters will be used to advice the trainer staff of the school to adjust their training interventions. This is normal routine too as the involved medical department has been advising the school for many years. Players will be followed up for 6 weeks. After those 6 weeks, the movement screening will be repeated to evaluate the change in the different outcome parameters. This last screening is not part of a normal routine as players normally are investigated more in a subjective way. The medical team and school want to change that routine.
Data will be used to further improve training modalities and sports performance and reduce injury risk in these young athletes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training intervention | Other | Other: Training interventionSee information elsewhere |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All students from the first degree of the Volleyball school will participate
- Male and female athletes will be included
- Signing of an informed consent and assent form (for young kids) to use data for research
- Agreement given by the medical staff to use data and allowing the kids to be accepted by the school
Key exclusion criteria (1 listed)
- When inclusion criteria are not met
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 |
|---|---|---|
| Training interventionBased on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training. Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school. | Other | Training intervention |
Primary outcome
Change of joint mobility
Time frame: Difference between baseline and 6 weeks
Mobility will be assessed by using goniometer measurements (degrees of movement)
Change of strength
Time frame: Difference between baseline and 6 weeks
Strength will be assessed by using handheld dynamo-meter data (Newton)
Change in balance score
Time frame: Difference between baseline and 6 weeks
Stability is measured using the score on the Star Excursion Balance Test (numeric score on balance scale)
Change in lower limb joint angles during a single leg drop vertical jump
Time frame: Difference between baseline and 6 weeks
Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
Change in lumbopelvic stability score
Time frame: Difference between baseline and 6 weeks
Lumbopelvic stability is scored using 9 clinical tests (Bend knee fall out, Active straight leg raise, prone knee bend, sitting knee extension, standing bow, pelvic tilt, one leg stance, backward rocking, forward rocking). Each test is given a score between 0 (poor performance) and 2 (good performance) adding up to a total score of 18.
Change in lower limb joint angles during a drop jump
Time frame: Difference between baseline and 6 weeks
Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
2 secondary outcomes
Individualized web diagram of all outcome measurements
Time frame: Baseline
Number of injuries
Time frame: Baseline information from medical investigation
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 3 Nov 2020.
- Individual participant dataSharing planned: No. No individual data will be shared with other researchers. Data will be available to the medical and trainers staff. For research purposes, all data will be made anonymous.
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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
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intervention in people with Injuries and Training, run by Universitaire Ziekenhuizen KU Leuven 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 4 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 3 Nov 2020. 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?
Change of joint mobility (time frame: Difference between baseline and 6 weeks). The study lists 6 primary outcomes in all. 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 3 Nov 2020.