Glenohumeral SubluxationNCT07768904
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
An observational study of Glenohumeral Subluxation and Neonatal Brachial Plexus Palsy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy, Brachial Plexus Injuries
- What is being tested?
- Shoulder Ultrasonography and Standardized Clinical Examination
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Study 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34668
Melike Nur Rençber, MD, +90 553 770 28 43, melibalat@gmail.com
Esra Giray, MD, +90 555 813 43 94, girayesra@hotmail.com
About this study
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.
Read the 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.
- Being tested
- Shoulder Ultrasonography, Standardized Clinical Examination
- Keywords
- Alpha Angle, Shoulder Ultrasonography, Erb's Palsy, Glenohumeral Dysplasia, Humeral Head Displacement
- Medical subject headings
- Shoulder Dislocation, Neonatal Brachial Plexus Palsy, Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder UltrasonographyDiagnostic test
Ultrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit.
Standardized Clinical ExaminationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Shoulder Ultrasonography; Other: Standardized Clinical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: Assessed at each clinical visit from 3 months to 1 year of age
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at each clinical visit from 3 months to 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral SubluxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768904
- Sponsor's protocol ID
- 24/648
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07768904
- Acronym / sponsor ID
- 24/648
- Keywords
- Alpha Angle, Shoulder Ultrasonography, Erb's Palsy, Glenohumeral Dysplasia, Humeral Head Displacement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with Neonatal Brachial Plexus Palsy | – | Diagnostic Test: Shoulder Ultrasonography, Other: Standardized Clinical ExaminationInfants 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. |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder UltrasonographyUltrasonographic measurement of the shoulder alpha angle and percentage of humeral head displacement (PHHD), to be performed at each clinical visit. | Diagnostic test | Infants with Neonatal Brachial Plexus Palsy |
| Standardized Clinical ExaminationStandardized physical examination including passive range of motion, Active Movement Scale, Toronto Test Score, and subluxation-specific clinical signs, to be performed at each visit. | Other | Infants with Neonatal Brachial Plexus Palsy |
Primary outcome
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.
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%.
6 secondary outcomes
Passive Range of Motion of the Shoulder and Elbow
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Active Movement Scale (AMS) Score
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Toronto Test Score
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)
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Upper Extremity Length Discrepancy
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Reinnervation Status
Time frame: Assessed at each clinical visit from 3 months to 1 year of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Glenohumeral Subluxation
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Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke
Glenohumeral Subluxation, Stroke
Active, not recruiting
The Effects of Upper-Extremity Plyometric Combined Strength Training in Overhead Athletes With Shoulder Instability
Glenohumeral Subluxation, Shoulder Subluxation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glenohumeral Subluxation and Neonatal Brachial Plexus Palsy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike Nur Rençber, MD (+90 553 770 28 43, melibalat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Alpha Angle (time frame: Assessed at each clinical visit from 3 months to 1 year of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.