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Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players (GIRDH)

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ClinicalTrials.gov Identifier: NCT02011243
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

December 9, 2013
December 13, 2013
March 26, 2015
January 2014
August 2014   (Final data collection date for primary outcome measure)
Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: 6 months ]
IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°
Same as current
Complete list of historical versions of study NCT02011243 on ClinicalTrials.gov Archive Site
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: baseline (Day 0) ]
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: 3 months ]
  • Measure of the internal rotation deficit [ Time Frame: baseline (day 0) ]
  • Measure of the internal rotation deficit [ Time Frame: 3 months ]
  • Measure of the internal rotation deficit [ Time Frame: 6 months ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: baseline (day 0) ]
    GRE 2 = measure of the external gain in rotation in position 2 Position 2 = dominant arm in abduction at 90°
  • The ratio of DRI 2 / GRE 2 [ Time Frame: 3 months ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: 6 months ]
  • Measure of the total range of motion [ Time Frame: baseline (day 0) ]
  • Measure of the total range of motion [ Time Frame: 3 months ]
  • Measure of the total range of motion [ Time Frame: 6 months ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: baseline (day 0) ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 3 months ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 6 months ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: baseline (day 0) ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 3 months ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 6 months ]
  • Presence/absence of shoulder pathology [ Time Frame: baseline (day 0) ]
  • Presence/absence of shoulder pathology [ Time Frame: 3 months ]
  • Presence/absence of shoulder pathology [ Time Frame: 6 months ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: baseline (day 0) ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: 3 months ]
  • Shoulder clinical exam: the arming apprehension test [ Time Frame: 6 months ]
  • Shoulder clinical exam: relocation test [ Time Frame: baseline (day 0) ]
  • Shoulder clinical exam: relocation test [ Time Frame: 3 months ]
  • Shoulder clinical exam: relocation test [ Time Frame: 6 months ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: baseline (day 0) ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: 3 months ]
  • Shoulder clinical exam: the O'Brien test [ Time Frame: 6 months ]
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: baseline (Day 0) ]
  • Presence/absence of an internal rotation deficit (IRD 2 > 20°) [ Time Frame: 3 months ]
  • Measure of the internal rotation deficit [ Time Frame: baseline (day 0) ]
  • Measure of the internal rotation deficit [ Time Frame: 3 months ]
  • Measure of the internal rotation deficit [ Time Frame: 6 months ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: baseline (day 0) ]
    GRE 2 = measure of the external gain in rotation in position 2 Position 2 = dominant arm in abduction at 90°
  • The ratio of DRI 2 / GRE 2 [ Time Frame: 3 months ]
  • The ratio of DRI 2 / GRE 2 [ Time Frame: 6 months ]
  • Measure of the total range of motion [ Time Frame: baseline (day 0) ]
  • Measure of the total range of motion [ Time Frame: 3 months ]
  • Measure of the total range of motion [ Time Frame: 6 months ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: baseline (day 0) ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 3 months ]
  • Presence/absence of pain when throwing (yes/no) [ Time Frame: 6 months ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: baseline (day 0) ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 3 months ]
  • Presence of discomfort when throwing (visual analog scale from 0 to 100) [ Time Frame: 6 months ]
  • Presence/absence of shoulder pathology [ Time Frame: baseline (day 0) ]
  • Presence/absence of shoulder pathology [ Time Frame: 3 months ]
  • Presence/absence of shoulder pathology [ Time Frame: 6 months ]
  • Shoulder clinical exam including the arming apprehension test, the relocation test and the O'Brien test [ Time Frame: baseline (day 0) ]
  • Shoulder clinical exam including the arming apprehension test, the relocation test and the O'Brien test [ Time Frame: 3 months ]
  • Shoulder clinical exam including the arming apprehension test, the relocation test and the O'Brien test [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players
Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season
The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study population is composed of all members of the professional and pre-professional handball clubs in the city of Nîmes, France (the USAM and HBCN clubs). Younger players who are members of the training centers associated with these same clubs will also be included.
  • Internal Rotation Contracture-shoulder
  • Articulation Disorders
  • Athletic Injuries
Not Provided
  • Professional players, men
    This group includes professional, male, handball players meeting study inclusion criteria.
  • Professional players, women
    This group includes professional, female, handball players meeting study inclusion criteria.
  • Junior players, men
    This group includes junior, male, handball players meeting study inclusion criteria.
  • Junior players, women
    This group includes junior, female, handball players meeting study inclusion criteria.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
120
August 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02011243
LOCAL/2013/OM-01
2013-A01183-42 ( Other Identifier: RCB number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Olivier Marès, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015