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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

12. august 2026 oppdatert av: Fatih Sultan Mehmet Training and Research Hospital
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

19

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34668
        • University of Health Sciences Turkey, Fatih Sultan Mehmet Training and Research Hospital
        • Hovedetterforsker:
          • Esra Giray, MD
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Melike Nur Rençber, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Infants with Neonatal Brachial Plexus Palsy
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.
Diagnostisk test: Shoulder Ultrasonography
Ultrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit.
Annen: Standardized 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ultrasonographic Alpha Angle
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age
Percentage of Humeral Head Displacement (PHHD)
Tidsramme: 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%.
Assessed at each clinical visit from 3 months to 1 year of age

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Passive Range of Motion of the Shoulder and Elbow
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age
Active Movement Scale (AMS) Score
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age
Toronto Test Score
Tidsramme: 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.
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)
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age
Upper Extremity Length Discrepancy
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age
Reinnervation Status
Tidsramme: 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.
Assessed at each clinical visit from 3 months to 1 year of age

Samarbeidspartnere og etterforskere

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Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

12. august 2026

Først lagt ut (Faktiske)

17. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24/648

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