Glenohumeral Internal Rotation Deficit (GIRD)GIRDNCT01422083
Glenohumeral Internal Rotation Deficit (GIRD)
A study testing home stretching program in people with Glenohumeral Internal Rotation Deficit (GIRD), run by University Ghent at 1 site in Belgium.
Trial summary
A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Glenohumeral Internal Rotation Deficit (GIRD)
- What is being tested?
- home stretching program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Jun 2015
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- overhead athletes: at least 3 hours/week training
- male and female
- 18-30 years of age
- No shoulder pain during last 3 months for which a doctor was consulted
- No shoulder surgery
- No neck diseases
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Loss of Internal Rotation Range of Motion and Size of the Subacromial Space and the Influence of a Home Stretching Program.
A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes this population interesting to investigate. This study wants to look at shoulders of overhead athletes with GIRD and measure the size of the subacromial space. After this, the athletes will be instructed to perform a home stretching program and at the end the effect of this on mobility and the size of the subacromial space will be measured.60 athletes will be recruited and randomly allocated to the control group and the stretching group. Before they start stretching, subacromial space size will be measured by use of ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a stretching exercise, which they will be performing at home once a day during 6 weeks. At the end all outcome measures will be reassessed.
- Being tested
- home stretching program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home stretching programProcedure or surgery
A home stretching program (sleeper's stretch): 3 x 30 seconds, once a day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group of athletes do not perform a 6-week stretching program. |
| Home stretching program | Experimental | These athletes take on a home stretching program (sleeper's stretch). Receives: Procedure: home stretching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the subacromial space and shoulder mobility.
Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.
Measured: at 0 weeks
Size of the subacromial space and shoulder mobility.
Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.
Measured: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral Internal Rotation Deficit (GIRD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Ann Cools, Ph.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422083
- Sponsor's protocol ID
- 2010/372
- Acronym
- GIRD
- Status last verified
- Nov 2021
- First submitted
- 22 Aug 2011
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Loss of Internal Rotation Range of Motion and Size of the Subacromial Space and the Influence of a Home Stretching Program.
- ClinicalTrials.gov ID
- NCT01422083
- Acronym / sponsor ID
- GIRD / 2010/372
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Sep 2010 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Aug 2011 (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.
A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes this population interesting to investigate. This study wants to look at shoulders of overhead athletes with GIRD and measure the size of the subacromial space. After this, the athletes will be instructed to perform a home stretching program and at the end the effect of this on mobility and the size of the subacromial space will be measured.60 athletes will be recruited and randomly allocated to the control group and the stretching group. Before they start stretching, subacromial space size will be measured by use of ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a stretching exercise, which they will be performing at home once a day during 6 weeks. At the end all outcome measures will be reassessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group of athletes do not perform a 6-week stretching program. |
| Home stretching program | Experimental | Procedure: home stretching programThese athletes take on a home stretching program (sleeper's stretch). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- overhead athletes: at least 3 hours/week training
- male and female
- 18-30 years of age
- No shoulder pain during last 3 months for which a doctor was consulted
- No shoulder surgery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| home stretching programA home stretching program (sleeper's stretch): 3 x 30 seconds, once a day for 6 weeks. | Procedure or surgery | Home stretching program |
Primary outcome
Size of the subacromial space and shoulder mobility.
Time frame: at 0 weeks
Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.
Size of the subacromial space and shoulder mobility.
Time frame: after 6 weeks
Measurment of the size of the subacromial space and shoulder mobility are performed by an ultrasound and an inclinometer.
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 19 Nov 2021.
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 Hospital, 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 home stretching program in people with Glenohumeral Internal Rotation Deficit (GIRD), run by University Ghent 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 6 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 19 Nov 2021. 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?
Size of the subacromial space and shoulder mobility. (time frame: at 0 weeks). The study lists 2 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 19 Nov 2021.