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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Shoulder Ultrasonography
Diagnostic testUltrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit.
Standardized Clinical Examination
Other interventionStandardized 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
Trial outcomes
Primary outcomes
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.
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%.
Secondary outcomes
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.
Active Movement Scale (AMS) Score
AMS score will be assessed at each visit as a clinical predictor of glenohumeral subluxation.
Toronto Test Score
Toronto Test Score will be calculated at each visit and evaluated for association with glenohumeral subluxation.
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.
Sponsors and contacts
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