Obstetrical Brachial Plexus PalsyROTPOPBNCT03440658
Deficits of Strength of the Rotator Muscles of the Shoulder in Children
An observational study of Obstetrical Brachial Plexus Palsy, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Obstetrical Brachial Plexus Palsy
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children with obstetrical brachial plexus palsy
Who may be able to join
- children with obstetrical brachial plexus palsy
Who cannot join
- other neurological disorders, post-traumatic shoulder stiffness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Obstetrical Brachial Plexus Palsy
- Keywords
- brachial plexus palsy, isokinetics, shoulder, strenght
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
atrophy
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
Measured: 1 day
Secondary outcomes (1)
active external or internal rotation deficit
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetrical Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion DELPONT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440658
- Sponsor's protocol ID
- RECHMPL18_0081
- Acronym
- ROTPOPB
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2018
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Balloufaud M, Hosni S, Bolivar J, Saguintaah M, Virassamy M, Laffont I, Coulet B, Lambert K, Delpont M. Subscapularis impairment on magnetic resonance imaging is correlated with functional limitations in neonatal brachial plexus palsy. Int Orthop. 2024 Jun;48(6):1635-1643. doi: 10.1007/s00264-023-06081-5. Epub 2024 Jan 3.
PubMed 38167960
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deficits of Strength of the Rotator Muscles of the Shoulder in Children With Sequelae of Obstetric Brachial Palsy.
- ClinicalTrials.gov ID
- NCT03440658
- Acronym / sponsor ID
- ROTPOPB / RECHMPL18_0081
- Conditions
- Obstetrical Brachial Plexus Palsy
- Keywords
- brachial plexus palsy, isokinetics, shoulder, strenght
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with obstetrical brachial plexus palsy
Key inclusion criteria (1 listed)
- children with obstetrical brachial plexus palsy
Key exclusion criteria (1 listed)
- other neurological disorders, post-traumatic shoulder stiffness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
active external or internal rotation deficit
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 38167960Balloufaud M, Hosni S, Bolivar J, Saguintaah M, Virassamy M, Laffont I, Coulet B, Lambert K, Delpont M. Subscapularis impairment on magnetic resonance imaging is correlated with functional limitations in neonatal brachial plexus palsy. Int Orthop. 2024 Jun;48(6):1635-1643. doi: 10.1007/s00264-023-06081-5. Epub 2024 Jan 3.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Obstetrical Brachial Plexus Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
RecruitingPhase 3
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Obstetrical Brachial Plexus Palsy
Not yet recruitingObservational study
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
Osbtetric Brachial Plexus Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion DELPONT, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetrical Brachial Plexus Palsy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrophy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.