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NCT Number: NCT07768904

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

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.

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Key information

Age range

3 month–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Turkey, Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location contact

Esra Giray, MD

CONTACT

[email protected]

+90 555 813 43 94

Esra Giray, MD

PRINCIPAL_INVESTIGATOR

Melike Nur Rençber, MD

CONTACT

[email protected]

+90 553 770 28 43

Melike Nur Rençber, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Ultrasonographic Alpha Angle

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

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

  2. Percentage of Humeral Head Displacement (PHHD)

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

    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

  1. Passive Range of Motion of the Shoulder and Elbow

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

    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.

  2. Active Movement Scale (AMS) Score

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

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

  3. Toronto Test Score

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

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

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

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

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

  5. Upper Extremity Length Discrepancy

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

    Difference in upper extremity length between the affected and unaffected sides will be measured at each visit and evaluated for association with glenohumeral subluxation.

  6. Reinnervation Status

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

    Neurological reinnervation status (full, partial, or none) will be assessed at each visit relative to the prior visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Giray, MD

CONTACT

[email protected]

+90 555 813 43 94

Melike Nur Rençber, MD

CONTACT

[email protected]

+90 553 770 28 43

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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