Internal Rotation Deficit of the Glenohumeral Joint in Ad... | NCT02011243

Studies
Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players

NCT02011243

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

86Actual

Phase

Not provided

Conditions

Internal Rotation Contracture-shoulder
Articulation Disorders
Athletic Injuries

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A01183-42	Other Identifier	RCB number

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Dec 9, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence/absence of an internal rotation deficit (IRD 2 > 20°)	IRD 2 = internal rotation deficit in position 2 Position 2 = dominant arm in abduction at 90°	6 months

Secondary Outcomes

Measure	Description	Time Frame
Presence/absence of an internal rotation deficit (IRD 2 > 20°)		baseline (Day 0)
Presence/absence of an internal rotation deficit (IRD 2 > 20°)		3 months
Measure of the internal rotation deficit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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.

Sampling Method

Non-Probability Sample

ID	Term
D013064	Speech Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations

ID	Term
D001184	Articulation Disorders
D001265	Athletic Injuries