Deficits of Strength of the Rotator Muscles of the Shoulder in Children (ROTPOPB)

October 22, 2021 updated by: University Hospital, Montpellier

Deficits of Strength of the Rotator Muscles of the Shoulder in Children With Sequelae of Obstetric Brachial Palsy.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

  2. 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.

  3. 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.
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children with obstetrical brachial plexus palsy

Description

Inclusion criteria:

- children with obstetrical brachial plexus palsy

Exclusion criteria:

- other neurological disorders, post-traumatic shoulder stiffness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
atrophy
Time Frame: 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
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
active external or internal rotation deficit
Time Frame: 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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marion DELPONT, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL18_0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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