ROTPOPB: Deficits of Strength of the Rotator Muscles of the Shoulder in Children

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03440658
Collaborator
(none)
20
1
36
0.6

Study Details

Study Description

Brief Summary

The purpose of this retrospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. First of all, the investigators want to study the reproducibility of the isometric contraction forces of the rotator muscles of the shoulder thanks to an isokinetic dynamometer. The investigatorsthen want to compare the measurements obtained from the paralyzed side compared to the healthy side. The preoperative MRI performed will be studied in search of amyotrophy. These data will be compared with those of the isokinetic assessment to identify children requiring muscle transfer of reinforcement of the external rotator muscles.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obstetrical brachial plexus palsy is caused by arm stretching at birth. Recovery is not complete in a third of cases. The main sequelae is a decrease in the mobility in external rotation (ER) of the shoulder at the clinical examination. This is attributed to an imbalance between the deficient external rotator muscles (mainly infraspinatus), and the internal rotator muscles (subscapularis, pectoralis major, latissimus dorsi). A stiffness would appear because of the permanent vicious attitude of the shoulder. There is a surgical indication for arthroscopic retraction before the age of 2 years. A muscle transfer to strengthen the shoulder RE can be performed secondarily from the age of 3 years in case of persistent sequelae but the investigators lack of objective elements to ask this indication.

    1. Study of the reproducibility of the isometric contraction forces of the internal and external rotator muscles obtained by isokinetic apparatus in paralyzed children.

    The isokinetic device is the gold standard for assessing muscle strength. The reproducibility of Peak Torque (PT) and Total Work (TT) will be analyzed in paralyzed children aged 3 to 5 years.

    1. Comparison of isometric contraction forces of internal and external rotator muscles obtained by isokinetic device in a group of POPB children.

    Inclusion criteria: patients with obstetrical brachial plexus palsy aged between 3 and 5 years. Investigation of a significant difference in PT and TT with respect to ER and IR on the paralyzed side compared to the healthy side.

    1. MRI analysis of muscular atrophy of the shoulders of paralyzed patients. The absence of recovery induces a deformation of the known shoulder joint with criteria to quantify it, but muscular amyotrophy has never been studied on the MRI of patients with brachial plexus palsy. Analysis of bilateral shoulder MRI of paralyzed patients (performed at 1 year of age as part of systematic follow-up if no-shoulder ER): describe and quantify muscle amyotrophy by measuring muscle thickness compared to healthy contralateral side. Index <0.5 in favor of amyotrophy, look for a positive correlation between the presence of muscular atrophy and joint deformity of the shoulder.

    2. What are the predictive factors for recovery of external and internal shoulder rotators of children with brachial obstetrical plexus palsy?

    By correlating the results of projects 1 to 3, it would be possible to:
    • to identify the favorable or unfavorable prognostic factors of shoulder recovery of paralyzed children.

    • identify patients with early signs of muscle recovery that do not require muscle transfer.

    Perspectives: change of the therapeutic algorithm

    • modification of the surgical technique according to the analysis of amyotrophy on the MRI: if subscapularis amyotrophic, more extended release with section of its upper fibers to mitigate its harmful effect on the development of the shoulder

    • not to make unnecessary muscle transfer in patients with recovery of external rotator muscles masked by subscapularis fibrosis. Transfer performed if necessary secondarily according to the testing of muscular strength at the age of 3 years by isokinetic device.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Deficits of Strength of the Rotator Muscles of the Shoulder in Children With Sequelae of Obstetric Brachial Palsy.
    Actual Study Start Date :
    Jul 1, 2018
    Actual Primary Completion Date :
    Jul 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. atrophy [1 day]

      The amyotrophy will be quantified by an index corresponding to the maximum muscle thickness measured on the MRI in T2 on the axial section passing under the spine of the scapula, between the injured side and the healthy side. This index will be measured from preoperative MRI of children. The existence of amyotrophy will be defined by an index <0.5

    Secondary Outcome Measures

    1. active external or internal rotation deficit [1 day]

      active external or internal rotation deficit: measured using the iso-kinetic testing technique and defined by a maximal force moment of the injured side <70% obtained from the healthy side

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • children with obstetrical brachial plexus palsy
    Exclusion criteria:
    • other neurological disorders, post-traumatic shoulder stiffness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Marion DELPONT, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03440658
    Other Study ID Numbers:
    • RECHMPL18_0081
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2021