NCT04148131

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

October 25, 2019

Last Update Submit

October 30, 2019

Conditions

Keywords

Brachial Plexusbirth injury

Outcome Measures

Primary Outcomes (1)

  • 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).

    a day (single measurement)

Secondary Outcomes (1)

  • Active Movement Scale

    a day (single measurement)

Study Arms (3)

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.

Eligibility Criteria

AgeUp to 36 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • being treated with conventional physiotherapy and routinely followed up by our clinic since birth.

You may not qualify if:

  • having a history of orthopaedic or neurologic surgery,
  • having low birth weight or premature birth history,
  • having a systemic, genetic or neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Birth InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MSc

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 1, 2019

Study Start

May 28, 2015

Primary Completion

June 30, 2016

Study Completion

December 20, 2016

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share