Muscle Viscoelastic Properties In Birth Palsy (Birth Palsy)

October 30, 2019 updated by: Kıvanç Delioğlu, Hacettepe University

Viscoelastic Properties of the Denervated Muscles in Children With Upper Trunk Obstetrical Brachial Plexus Palsy

The aim of study was to observe changes in denervated muscles viscoelastic properties and motor performance of OBPP children. Viscoelastic properties have a significant effect on muscle performance; however have not investigated yet in denervated muscle. Hypothesized that the viscoelastic properties of denervated muscles are different than healthy side muscles and can vary depending on the age groups. 74 patients who have C5-C6 root lesion were enrolled to the study. The patients were grouped according to their age groups: 1-5 months, 6-24 months and 25-36 months. Myoton-3 myotonometric measuring device was used to measure the viscoelastic properties (tone, elasticity and stiffness) of deltoid, biceps brachii. Active Movement Scale were used to evaluate the motor function of the muscles. There were difference in muscle viscoelastic properties depending on age group. Children aged 0-5 months showed significant difference in deltoid muscle tone (p=0.0001), stiffness (p=0.0001), biceps brachii muscle tone (p=0.0001) and stiffness (p=0.0001), when compared with other groups (denervated side was lower in values).

Therefore, it is in our opinion that in follow-up, clinical assessment of viscoelastic properties will be useful for monitoring denervated muscle; also treatment programs and purposes for OBPP should be varying according to the muscle properties.

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

Birth lesion of the brachial plexus, generally referred as "obstetric brachial plexus palsy (OBPP)", frequently includes traction or tearing of the nerve plexus that supply motor, sensory and autonomic innervation to the arm. The extent of damage can vary depending on severity of the injuries; from single nerve root to total root lesions. Impact of OBPP can be seen as transient functional insufficiencies to lifelong total disability, depending on the injury severity. The incidence of OBPP varies between 1.3 - 1.5 per 1000 births in different countries. The most common risk factor for birth injury is shoulder dystocia. Other risk factors are macrosomia, prolonged labor, multiparity, maternal pelvic anatomy and ethnic background.Denervation after delivery leads changes in the muscle tissue due to incomplete maturation of the muscles. The muscle tissue cannot grow longitudinally and have higher connective tissue content. Additionally, muscle strength gain, and development are impaired in the denervation process due to fibrosis and fat infiltration. Many studies demonstrated alterations in histomorphological features of denervated muscles in OBPP via magnetic resonance, ultrasound imaging and gene analysis. Despite many structural alterations in muscles have been investigated; changes in the viscoelastic properties, including muscle tone (tonus), stiffness and elasticity of the muscles, during denervation and reinnervation processes have not yet been investigated in patients with OBPP. The aim of our study was to observe changes in denervated muscles viscoelastic properties and motor performance of OBPP children. Viscoelastic properties have a significant effect on muscle performance; however have not investigated yet in denervated muscle. Hypothesized that the viscoelastic properties of denervated muscles are different than healthy side muscles and can vary depending on the age groups. 74 patients who have C5-C6 root lesion were enrolled to the study. The patients were grouped according to their age groups: 1-5 months, 6-24 months and 25-36 months. Myoton-3 myotonometric measuring device was used to measure the viscoelastic properties (tone, elasticity and stiffness) of deltoid, biceps brachii. Active Movement Scale were used to evaluate the motor function of the muscles. We found different muscle viscoelastic properties depending on age group. Children aged 0-5 months showed significant difference in deltoid muscle tone (p=0.0001), stiffness (p=0.0001), biceps brachii muscle tone (p=0.0001) and stiffness (p=0.0001), when compared with other groups (denervated side was lower in values).Therefore, it is in our opinion that in follow-up, clinical assessment of viscoelastic properties will be useful for monitoring denervated muscle; also treatment programs and purposes for OBPP should be varying according to the muscle properties.

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.
74

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

No older than 3 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • The Population have Obstetric Brachial Plexus Palsy
  • Seventy-four (25 boys, 49 girls) children aged between 1-36 months (15.12±10.58) with Narakas type 2 injury (C5-C6 upper trunk involvement) were enrolled to the study

Description

Inclusion Criteria:

  • Our inclusion criteria were; having only C5-C6 root injury, being classified as Narakas type 2,
  • being treated with conventional physiotherapy and routinely followed up by our clinic since birth.

Exclusion Criteria:

  • Our exclusion criteria were having a root injury other than C5-C6,
  • having a history of orthopaedic or neurologic surgery,
  • having low birth weight or premature birth history,
  • having a systemic, genetic or neuromuscular disease.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1, 0-5 months old
Children which is Obstetric brachial plexus palsy and 0-5 months old age have Naracas type 2 lesion.
Group 2, 6-24 months old
Children which is Obstetric brachial plexus palsy and 6-24 months old age have Naracas type 2 lesion.
Group 3, 25-36 months old
Children which is Obstetric brachial plexus palsy and 25-36 months old age have Naracas type 2 lesion.

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
Myotone-3, Viscoelastic Properties Measurement
Time Frame: a day (single measurement)
Viscoelastic properties of deltoid and biceps brachii muscles in both denervated and healthy sides were analyzed with using Myoton-3 device, which is a reliable handhold device for measuring viscoelastic properties of muscles by recording the damped mechanical oscillations; and provides objective, painless and noninvasive way to measure quantitative value of the muscle tone, stiffness and elasticity, invented at the University of Tartu in Estonia (Müomeetria AS, Estonia, EU) (ICC: 0,80-0,93).
a day (single measurement)

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 Movement Scale
Time Frame: a day (single measurement)
The Active Movement Scale (AMS) was developed, specifically for children with OBPP, to investigate motor performance of denervated upper extremity and to evaluate 15 motions in upper extremity. The scoring system uses a 7-point scale for movement, based on the percentage of active movement observed considering full range of motion for each joint. 0-4 points are given for movement of the joint in the gravity minimized position. Points 5-7 are given based on performing activities against gravity.
a day (single measurement)

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.
Hacettepe University

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.
May 28, 2015

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.
June 30, 2016

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.
December 20, 2016

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).
October 25, 2019

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.
October 30, 2019

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.
November 1, 2019

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.
November 1, 2019

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 30, 2019

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, 2019

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.
  • kıvançOBPP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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