NCT07651306

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 10, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

StrokeCortical Bone ThicknessOsteoporosisRadiography

Outcome Measures

Primary Outcomes (1)

  • Difference in Proximal Humerus Cortical Bone Thickness Between Paretic and Non-Paretic Sides

    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

Secondary Outcomes (2)

  • Correlation Between Radiographic Cortical Bone Thickness and Systemic Bone Mineral Density

    Baseline

  • Correlation Between Radiographic Cortical Bone Thickness and Systemic T-scores

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

OsteoporosisStroke

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ismet Alkim Ozkan MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

February 22, 2026

Primary Completion

June 25, 2026

Study Completion

July 1, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

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