An observational study in Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy and Brachial Plexus Injuries, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Months to 1 Year. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational
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.
Infants aged 3 months to 1 year with neonatal brachial plexus injury (Narakas Group I-III) will be evaluated at a single pediatric rehabilitation clinic. At each visit, the same physiatrist will perform a standardized clinical examination, including assessment of demographic and obstetric history, subluxation-specific clinical signs (axillary skin fold asymmetry, palpable posterior fullness), passive range of motion, upper extremity length discrepancy, the Active Movement Scale, and the Toronto Test Score. A second physiatrist, blinded to clinical findings, will perform shoulder ultrasonographic evaluation using a posterior approach to measure the alpha angle and the percentage of humeral head displacement (PHHD). Glenohumeral subluxation will be defined as an alpha angle greater than 30 degrees; dislocation will be defined as an alpha angle greater than 30 degrees combined with PHHD greater than 50%. Associations between clinical findings and ultrasonographic subluxation will be analyzed using Generalized Linear Mixed Models to account for repeated measurements per patient, followed by ROC curve analysis to identify optimal predictive thresholds.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 19 is below the median of 86 across 28 observational studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 120 studies on the registry; 34 are open to participants now.
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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
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Exclusion Criteria:
Infants aged 3 months to 1 year with neonatal brachial plexus injury (Narakas Group I-III) who will undergo standardized clinical examination and shoulder ultrasonographic evaluation at each visit.
Diagnostic Test: Shoulder Ultrasonography · Other: Standardized Clinical Examination
Ultrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit.
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.
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
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
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
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
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
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
Upper Extremity Length Discrepancy
Difference in upper extremity length between the affected and unaffected sides will be measured 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
Reinnervation Status
Neurological reinnervation status (full, partial, or none) will be assessed at each visit relative to the prior visit.
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Plan to share: Undecided
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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