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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-1
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

This study will examine infants with a birth-related nerve injury called neonatal brachial plexus palsy, which can affect movement in the arm and sometimes cause the shoulder joint to shift out of its normal position (subluxation). Researchers will use ultrasound imaging to measure the shoulder joint and will compare these measurements with findings from a physical examination, to determine which clinical signs can help predict whether a baby's shoulder will develop this problem. The goal is to help doctors detect shoulder problems earlier, so that treatment can start sooner.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of neonatal brachial plexus injury (NBPI) between 3 months and 1 year of age

Narakas classification Group I, II, or III

Absence of nerve root avulsion

Disqualifiers

Prior shoulder surgery for NBPI

Inability to tolerate ultrasonographic examination

Concomitant musculoskeletal (e.g., torticollis, humeral fracture) or neurological disease

Bilateral NBPI

Trial population

Infants diagnosed with neonatal brachial plexus injury who present to the Pediatric Rehabilitation Clinic of the University of Health Sciences Turkey, Fatih Sultan Mehmet Training and Research Hospital, and who meet the eligibility criteria, will be consecutively enrolled in the study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Shoulder Ultrasonography

    Diagnostic test

    Ultrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit.

  • Standardized Clinical Examination

    Other intervention

    Standardized physical examination including passive range of motion, Active Movement Scale, Toronto Test Score, and subluxation-specific clinical signs, to be performed at each visit.

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: Infants with Neonatal Brachial Plexus Palsy2 interventions

Trial outcomes

Primary outcomes

1

Ultrasonographic Alpha Angle

Alpha angle will be measured sonographically at each shoulder examination. Glenohumeral subluxation will be defined as an alpha angle greater than 30 degrees.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age
2

Percentage of Humeral Head Displacement (PHHD)

PHHD will be measured sonographically at each shoulder examination. Glenohumeral dislocation will be defined as an alpha angle greater than 30 degrees combined with PHHD greater than 50%.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age

Secondary outcomes

1

Passive Range of Motion of the Shoulder and Elbow

Passive range of motion of the shoulder (flexion, extension, abduction, internal and external rotation) and elbow (flexion, extension) will be measured using standard goniometry at each visit and evaluated for association with glenohumeral subluxation.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age
2

Active Movement Scale (AMS) Score

AMS score will be assessed at each visit as a clinical predictor of glenohumeral subluxation.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age
3

Toronto Test Score

Toronto Test Score will be calculated at each visit and evaluated for association with glenohumeral subluxation.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age
4

Subluxation-Specific Clinical Signs (Axillary Skin Fold Asymmetry and Palpable Posterior Fullness)

Presence of axillary skin fold asymmetry and palpable posterior shoulder fullness will be assessed at each visit and evaluated for association with glenohumeral subluxation.

Time frame
Assessed at each clinical visit from 3 months to 1 year of age

Other outcomes

Sponsors and contacts

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