- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011243
Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players (GIRDH)
Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season
Study Overview
Status
Detailed Description
The secondary objectives of this study are :
A- To estimate and compare the prevalence of Internal Rotation Deficit within groups
B- To assess the association between the Internal Rotation Deficit and the appearance of a shoulder pain and/or discomfort when throwing
C- To assess the association between Internal Rotation Deficit and the appearance of a shoulder pathology demonstrated by clinical examination by at least one abnormality in one of the following three tests: the arming apprehension test, the relocation test or the O'Brien test
D- Assess changes in values of IRD 2, the ratio IRD 2/GRE 2, and the Total Range of Motion over the training season
E- Evaluate the association between the values of IRD 2 and the appearance of shoulder pain or discomfort when throwing
F- To evaluate the association between IRD 2 values and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
G- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of shoulder pain or discomfort when throwing
H- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).
I- To estimate the optimal threshold value of the IRD 2/GRE 2 ratio that would define an Internal Rotation Deficit in a more relevant fashion as compred to the IRD 2 alone
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nîmes Cedex 9, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The subject or his/her legal guardian must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- The subject is a member of the professional and pre-professional handball clubs in Nîmes, France (the USAM or HBCN clubs) -- OR-- a member of the training centers associated with the same clubs whose parents or legal representatives have given informed consent
Exclusion Criteria:
- The subject is under judicial protection, under tutorship or curatorship
- The subject or his/her legal respresentative refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject is pregnant, parturient, or breastfeeding
- The subject has been operated for shoulder instability, regardless of the surgical technique used
- The subject has a history of fracture of the proximal end of the humerus and / or elbow
- The subject has a history of rotator cuff surgery
- The subject has neurological or spinal problems, or has received physiotherapy on the shoulder complex within 30 days prior to the study assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Professional players, men
This group includes professional, male, handball players meeting study inclusion criteria.
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Professional players, women
This group includes professional, female, handball players meeting study inclusion criteria.
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Junior players, men
This group includes junior, male, handball players meeting study inclusion criteria.
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Junior players, women
This group includes junior, female, handball players meeting study inclusion criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time Frame: 6 months
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IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time Frame: baseline (Day 0)
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baseline (Day 0)
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Presence/absence of an internal rotation deficit (IRD 2 > 20°)
Time Frame: 3 months
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3 months
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Measure of the internal rotation deficit
Time Frame: baseline (day 0)
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baseline (day 0)
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Measure of the internal rotation deficit
Time Frame: 3 months
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3 months
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Measure of the internal rotation deficit
Time Frame: 6 months
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6 months
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The ratio of DRI 2 / GRE 2
Time Frame: baseline (day 0)
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GRE 2 = measure of the external gain in rotation in position 2 Position 2 = dominant arm in abduction at 90°
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baseline (day 0)
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The ratio of DRI 2 / GRE 2
Time Frame: 3 months
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3 months
|
|
The ratio of DRI 2 / GRE 2
Time Frame: 6 months
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6 months
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Measure of the total range of motion
Time Frame: baseline (day 0)
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baseline (day 0)
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Measure of the total range of motion
Time Frame: 3 months
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3 months
|
|
Measure of the total range of motion
Time Frame: 6 months
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6 months
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Presence/absence of pain when throwing (yes/no)
Time Frame: baseline (day 0)
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baseline (day 0)
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Presence/absence of pain when throwing (yes/no)
Time Frame: 3 months
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3 months
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Presence/absence of pain when throwing (yes/no)
Time Frame: 6 months
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6 months
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Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time Frame: baseline (day 0)
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baseline (day 0)
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Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time Frame: 3 months
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3 months
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Presence of discomfort when throwing (visual analog scale from 0 to 100)
Time Frame: 6 months
|
6 months
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Presence/absence of shoulder pathology
Time Frame: baseline (day 0)
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baseline (day 0)
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Presence/absence of shoulder pathology
Time Frame: 3 months
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3 months
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Presence/absence of shoulder pathology
Time Frame: 6 months
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6 months
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Shoulder clinical exam: the arming apprehension test
Time Frame: baseline (day 0)
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baseline (day 0)
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Shoulder clinical exam: the arming apprehension test
Time Frame: 3 months
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3 months
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Shoulder clinical exam: the arming apprehension test
Time Frame: 6 months
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6 months
|
|
Shoulder clinical exam: relocation test
Time Frame: baseline (day 0)
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baseline (day 0)
|
|
Shoulder clinical exam: relocation test
Time Frame: 3 months
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3 months
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Shoulder clinical exam: relocation test
Time Frame: 6 months
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6 months
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Shoulder clinical exam: the O'Brien test
Time Frame: baseline (day 0)
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baseline (day 0)
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Shoulder clinical exam: the O'Brien test
Time Frame: 3 months
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3 months
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Shoulder clinical exam: the O'Brien test
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2013/OM-01
- 2013-A01183-42 (Other Identifier: RCB number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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