NCT02011243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

December 9, 2013

Last Update Submit

March 25, 2015

Conditions

Keywords

deficitinternal rotationgleno humeral articulationhand ball

Outcome Measures

Primary Outcomes (1)

  • 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 (29)

  • 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

    baseline (day 0)

  • Measure of the internal rotation deficit

    3 months

  • Measure of the internal rotation deficit

    6 months

  • +24 more secondary outcomes

Study Arms (4)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Articulation DisordersAthletic Injuries

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Olivier Marès, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 13, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations