Risk Factors for Shoulder InjuriesNCT01266278
Analysis of Sport Specific Adaptations of the Shoulder in Adolescent Elite Handball Players and the Influence of the Preventive Use of Tape on These Outcome Measurements.
A study testing Dynamic ultrasound, FASTRAK and Assessment of shoulder posture by measuring in people with Risk Factors for Shoulder Injuries, run by University Ghent at 1 site in Netherlands.
Trial summary
Shoulder complaints are very common in overhead athletes.The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this. This could enlarge the dynamic size of the subacromial space and thus contribute to prevention of shoulder injuries. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Factors for Shoulder Injuries
- What is being tested?
- Dynamic ultrasound, FASTRAK and Assessment of shoulder posture by measuring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Nov 2010
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Elite handball players of Papendal
- age between 15 and 25
- more than 15 hours of handball training/week
- female
Who cannot join
- shoulder pain at the moment for which a doctor was consulted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Sport Specific Adaptations of the Shoulder in Adolescent Elite Handball Players and the Influence of the Preventive Use of Tape on Shoulder Strength, Mobility, the Position of the Scapula and the Size of the Subacromial Space.
Shoulder complaints are very common in overhead athletes.The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this.
This could enlarge the dynamic size of the subacromial space and thus contribute to prevention of shoulder injuries.
Read more
30 young elite handball players will participate in this study.Researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position:
- measurement of subacromial space
- measurement of 3D kinematics of shoulder
- assessment of shoulder posture
Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space.This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.
Read the detailed description
Shoulder complaints are very common in overhead athletes. Throwing motions question large explosive strength and stability of the intrinsic instable shoulder joint. Malpositioning of the scapula increases the risk of overload injuries.
The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this. Until now no studies have shown if the tape is able to correct the position of the scapula. If this is the case, the application of the tape could enlarge the dynamic size of the subacromial space (virtual space in the shoulder in which rotator cuff tendons run through) and thus contribute to prevention of shoulder injuries.
This study will take place in collaboration with Prof. Dr. Robert Van Cingel, director of the Sports Medical Center Papendal(SMCP) in the Netherlands. SMCP is a multidisciplinary center for sports medicine, sports rehabilitation and sports cardiology.
30 young elite handball players will participate in this study. Three researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position.
- Measurement of the size of the subacromial space with dynamic ultrasound. Ultrasound is completely harmless and painless.
- Measurement of three-dimensional kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape. Both placement of markers and measurements are non-invasive and painless.
- Assessment of shoulder posture by measuring several angles and distances. Measurement of shoulder strength and mobility. These measurements are all non-invasive and painless.
Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space. This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.
- Conditions
- Risk Factors for Shoulder Injuries
- Being tested
- Dynamic ultrasound, FASTRAK, Assessment of shoulder posture by measuring
- Keywords
- shoulder injuries
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic ultrasoundOther
Measurement of the size of the subacromial space with dynamic ultrasound.
FASTRAKOther
Measurements of the 3D-kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape.
Assessment of shoulder posture by measuringOther
Assessment of shoulder posture by measuring several angles and distances.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | Kinesiotape will be applied to the correct shoulder position of the participants. Receives: Other: Dynamic ultrasound; Other: FASTRAK; Other: Assessment of shoulder posture by measuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of kinesiotape
Immediate effects of applying kinesiotape to the correct shoulder position
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Ann Cools, Ph.D., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266278
- Sponsor's protocol ID
- EC/2010/637
- Status last verified
- Jun 2011
- First submitted
- 14 Dec 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Sport Specific Adaptations of the Shoulder in Adolescent Elite Handball Players and the Influence of the Preventive Use of Tape on Shoulder Strength, Mobility, the Position of the Scapula and the Size of the Subacromial Space.
- ClinicalTrials.gov ID
- NCT01266278
- Acronym / sponsor ID
- EC/2010/637
- Conditions
- Risk Factors for Shoulder Injuries
- Keywords
- shoulder injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Dec 2010 (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.
Shoulder complaints are very common in overhead athletes.The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this.
This could enlarge the dynamic size of the subacromial space and thus contribute to prevention of shoulder injuries.
30 young elite handball players will participate in this study.Researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position:
- measurement of subacromial space
- measurement of 3D kinematics of shoulder
- assessment of shoulder posture
Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space.This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.
Detailed description
Shoulder complaints are very common in overhead athletes. Throwing motions question large explosive strength and stability of the intrinsic instable shoulder joint. Malpositioning of the scapula increases the risk of overload injuries.
The application of kinesiotape that keeps the shoulder in a correct position is used to avoid this. Until now no studies have shown if the tape is able to correct the position of the scapula. If this is the case, the application of the tape could enlarge the dynamic size of the subacromial space (virtual space in the shoulder in which rotator cuff tendons run through) and thus contribute to prevention of shoulder injuries.
This study will take place in collaboration with Prof. Dr. Robert Van Cingel, director of the Sports Medical Center Papendal(SMCP) in the Netherlands. SMCP is a multidisciplinary center for sports medicine, sports rehabilitation and sports cardiology.
30 young elite handball players will participate in this study. Three researchers will perform a number of measurements before and after applying kinesiotape to correct shoulder position.
- Measurement of the size of the subacromial space with dynamic ultrasound. Ultrasound is completely harmless and painless.
- Measurement of three-dimensional kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape. Both placement of markers and measurements are non-invasive and painless.
- Assessment of shoulder posture by measuring several angles and distances. Measurement of shoulder strength and mobility. These measurements are all non-invasive and painless.
Hypothesis of this study is that tape can influence the position of the scapula and is therefore able to change the size of the subacromial space. This results in a more efficient use of shoulder muscles with higher maximal strength as a result and maximizes shoulder mobility.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Other: Dynamic ultrasound, Other: FASTRAK, Other: Assessment of shoulder posture by measuringKinesiotape will be applied to the correct shoulder position of the participants. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Elite handball players of Papendal
- age between 15 and 25
- more than 15 hours of handball training/week
- female
Key exclusion criteria (1 listed)
- shoulder pain at the moment for which a doctor was consulted
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 |
|---|---|---|
| Dynamic ultrasoundMeasurement of the size of the subacromial space with dynamic ultrasound. | Other | Kinesiotape |
| FASTRAKMeasurements of the 3D-kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape. | Other | Kinesiotape |
| Assessment of shoulder posture by measuringAssessment of shoulder posture by measuring several angles and distances. | Other | Kinesiotape |
Primary outcome
effect of kinesiotape
Time frame: 2 days
Immediate effects of applying kinesiotape to the correct shoulder position
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 23 Jun 2011.
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.
Ann Cools, Ph.D. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic ultrasound, FASTRAK and Assessment of shoulder posture by measuring in people with Risk Factors for Shoulder Injuries, run by University Ghent at 1 site in Netherlands.
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 23 Jun 2011. 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 Netherlands. 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?
effect of kinesiotape (time frame: 2 days). 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 23 Jun 2011.