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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07768904
Enrollment
19
Registered
2026-08-17
Start date
2026-08-01
Completion date
2027-11-01
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Injuries, Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy

Keywords

Alpha Angle, Shoulder Ultrasonography, Erb's Palsy, Glenohumeral Dysplasia, Humeral Head Displacement

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTShoulder Ultrasonography

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

OTHERStandardized Clinical Examination

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.

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 1 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Prior shoulder surgery for NBPI * Inability to tolerate ultrasonographic examination * Concomitant musculoskeletal (e.g., torticollis, humeral fracture) or neurological disease * Bilateral NBPI * Narakas classification Group IV * Botulinum toxin injection to the affected shoulder

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonographic Alpha AngleAssessed at each clinical visit from 3 months to 1 year of ageAlpha 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)Assessed at each clinical visit from 3 months to 1 year of agePHHD 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

MeasureTime frameDescription
Passive Range of Motion of the Shoulder and ElbowAssessed at each clinical visit from 3 months to 1 year of agePassive 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) ScoreAssessed at each clinical visit from 3 months to 1 year of ageAMS score will be assessed at each visit as a clinical predictor of glenohumeral subluxation.
Toronto Test ScoreAssessed at each clinical visit from 3 months to 1 year of ageToronto 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)Assessed at each clinical visit from 3 months to 1 year of agePresence of axillary skin fold asymmetry and palpable posterior shoulder fullness will be assessed at each visit and evaluated for association with glenohumeral subluxation.
Upper Extremity Length DiscrepancyAssessed at each clinical visit from 3 months to 1 year of ageDifference in upper extremity length between the affected and unaffected sides will be measured at each visit and evaluated for association with glenohumeral subluxation.
Reinnervation StatusAssessed at each clinical visit from 3 months to 1 year of ageNeurological reinnervation status (full, partial, or none) will be assessed at each visit relative to the prior visit.

Countries

Turkey (Türkiye)

Contacts

CONTACTMelike Nur Rençber, MD
melibalat@gmail.com+90 553 770 28 43
CONTACTEsra Giray, MD
girayesra@hotmail.com+90 555 813 43 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026