Birth InjuriesBirth PalsyNCT04148131
Muscle Viscoelastic Properties In Birth Palsy
An observational study of Birth Injuries and Obstetric; Injury, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Birth Injuries, Obstetric; Injury
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2015to 20 Dec 2016
- 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 Up to 36 months
- All sexes
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Birth Injuries, Obstetric; Injury
- Keywords
- Brachial Plexus, birth injury
- Medical subject headings
- Birth Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Myotone-3, Viscoelastic Properties 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).
Measured: a day (single measurement)
Secondary outcomes (1)
Active Movement Scale
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.
Measured: a day (single measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start28 May 2015
- Primary completion30 Jun 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kıvanç Delioğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148131
- Sponsor's protocol ID
- kıvançOBPP
- Acronym
- Birth Palsy
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscoelastic Properties of the Denervated Muscles in Children With Upper Trunk Obstetrical Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT04148131
- Acronym / sponsor ID
- Birth Palsy / kıvançOBPP
- Conditions
- Birth Injuries, Obstetric; Injury
- Keywords
- Brachial Plexus, birth injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 May 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 1 Nov 2019 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
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).
1 secondary outcome
Active Movement Scale
Time frame: a day (single measurement)
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 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Birth Injuries
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Prenatal Yoga Intervention in Pregnant Women
Pregnant Women, Prenatal Yoga
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Injuries and Obstetric; Injury, run by Hacettepe University.
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 2 inclusion and 4 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Myotone-3, Viscoelastic Properties Measurement (time frame: a day (single measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.