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Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss

Post-stroke immobilization and reduced weight-bearing frequently lead to significant regional bone mineral density loss and asymmetry, particularly in the paretic upper extremity, which increases fracture risks. While Dual-Energy X-ray Absorptiometry (DXA) is the gold standard for evaluating systemic bone loss, it primarily focuses on axial or lower extremity sites and lacks universal accessibility. Since routine shoulder radiographs offer an opportunistic screening tool to evaluate regional bone quality without additional radiation , this study aims to compare proximal humerus cortical bone thickness between the paretic and non-paretic sides in stroke patients and assess its correlation with systemic DXA values to determine its clinical utility.

This cross-sectional, observational study involves a retrospective data analysis of patients aged 18 and older who experienced a single unilateral stroke at least 6 months prior and present with clinical hemiparesis. Eligible participants must have concurrent standard anteroposterior shoulder radiographs and DXA measurements available from their routine clinical follow-ups. Patient demographic data, stroke characteristics, Brunnstrom stages, and systemic DXA measurements (femoral neck and lumbar spine T-scores and bone mineral density values) are systematically recorded for analysis.

Cortical bone thickness measurements are performed using ImageJ software on standard radiographs at points 10 cm and 12 cm distal to the highest point of the humerus. To ensure reliability, measurements for both the paretic and non-paretic sides are conducted independently by two researchers who are completely blinded to the DXA results. Statistical analyses, including paired t-tests or Wilcoxon tests and Pearson or Spearman correlations, will be used to compare the sides and evaluate the relationship between radiographic cortical thickness and systemic bone density.

Aperçu de l'étude

Description détaillée

Background Post-stroke immobilization and reduced weight-bearing often lead to significant regional bone mineral density (BMD) loss and asymmetry, particularly in the paretic upper extremity, which increases fracture risks. While Dual-Energy X-ray Absorptiometry (DXA) is the gold standard for evaluating systemic bone loss, it primarily targets axial or lower extremity sites and may not be universally accessible in every clinical setting. Routine clinical imaging, such as standard shoulder radiographs, presents a valuable opportunistic screening tool to assess regional cortical bone quality without exposing patients to additional radiation.

Objective The primary objective of this cross-sectional, observational study is to compare proximal humerus cortical bone thickness between the paretic and non-paretic sides in patients with stroke. Additionally, the study aims to evaluate the correlation between radiographic cortical thickness measurements and systemic DXA values to determine the clinical utility of standard X-rays in identifying post-stroke regional bone loss.

Study Design and Methods This retrospective data analysis will include patients aged 18 and older with a history of a single unilateral stroke occurring at least 6 months prior, and presenting with clinical hemiparesis. Eligible participants must have concurrent standard anteroposterior shoulder radiographs and DXA measurements.

Measurement Protocol: Cortical bone thickness (CBT) will be measured at 10 cm and 12 cm distal to the highest point of the humerus using standard radiographs via ImageJ software.

Blinding: Measurements will be independently performed by two separate researchers who are completely blinded to the patients' DXA results.

Comparison: The radiographic cortical thickness values from both paretic and non-paretic sides will be correlated and compared against femoral neck and lumbar spine (L1-L4) DXA T-scores and BMD values.

Type d'étude

Observationnel

Inscription (Estimé)

65

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Istanbul, Turquie (Türkiye)
        • Recrutement
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults aged 18 years and older recruited from the clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants will include hemiparetic individuals with a history of a single unilateral stroke occurring at least 6 months prior, who possess concurrent standard shoulder radiographs and systemic dual-energy X-ray absorptiometry measurements.

La description

Inclusion Criteria:

  • Patients aged 18 years and older.
  • A documented history of a single unilateral stroke that occurred at least 6 months prior to evaluation.
  • Presence of clinical hemiparesis.
  • Availability of concurrent standard anteroposterior (AP) shoulder radiographs taken within 6 months post-stroke alongside systemic DXA measurements.

Exclusion Criteria:

  • History of surgical intervention in either shoulder. History of a proximal humerus fracture.
  • Co-existing metabolic bone diseases, such as primary hyperparathyroidism or osteomalacia.
  • History of malignancy.
  • Documented history of corticosteroid use.
  • Imaging artifacts that compromise the accuracy of DXA measurements.
  • History of a secondary stroke.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Poststroke Hemiparetic Individuals
This observational, retrospective cohort consists of hemiparetic adult patients aged 18 years and older who experienced a single, unilateral stroke at least 6 months prior. Selected participants must have concurrent systemic DXA measurements and standard anteroposterior shoulder radiographs taken within 6 months post-stroke from routine clinical follow-ups.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in Proximal Humerus Cortical Bone Thickness Between Paretic and Non-Paretic Sides
Délai: Baseline
The average cortical bone thickness measured in millimeters on standard anteroposterior shoulder radiographs. Measurements are taken at exact locations 10 cm and 12 cm distal to the highest anatomical peak of the humerus on both the paretic and non-paretic sides to evaluate localized bone loss asymmetry.
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation Between Radiographic Cortical Bone Thickness and Systemic Bone Mineral Density
Délai: Baseline
The correlation between the radiographic proximal humerus cortical thickness and systemic DXA values, specifically the bone mineral density (g/cm^2) of the femoral neck and the lumbar spine.
Baseline
Correlation Between Radiographic Cortical Bone Thickness and Systemic T-scores
Délai: Baseline
The correlation between the humerus cortical thickness measurements and systemic DXA T-scores to determine the clinical utility of standard X-rays in reflecting systemic osteopenia or osteoporosis classifications.
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 février 2026

Achèvement primaire (Estimé)

25 juin 2026

Achèvement de l'étude (Estimé)

1 juillet 2026

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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