Hemiparesis After StrokeNCT07651306
Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss
An observational study of Hemiparesis After Stroke and Dual Energy X-ray Absorptiometry, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis After Stroke, Dual Energy X-ray Absorptiometry, Osteoporosis
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2026to 1 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
Ismet Alkim Ozkan MD, +905356350591, dr.alkimozkan@gmail.com
About this study
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.
Read the detailed description
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.
- Keywords
- Stroke, Cortical Bone Thickness, Osteoporosis, Radiography
- Medical subject headings
- Osteoporosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Correlation Between Radiographic Cortical Bone Thickness and Systemic Bone Mineral Density
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.
Measured: Baseline
Correlation Between Radiographic Cortical Bone Thickness and Systemic T-scores
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start22 Feb 2026
- Primary completion25 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis After StrokeStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cansin Medin, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651306
- Sponsor's protocol ID
- IstanbulPMRTRH5
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss
- ClinicalTrials.gov ID
- NCT07651306
- Acronym / sponsor ID
- IstanbulPMRTRH5
- Keywords
- Stroke, Cortical Bone Thickness, Osteoporosis, Radiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 22 Feb 2026 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Jun 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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Proximal Humerus Cortical Bone Thickness Between Paretic and Non-Paretic Sides
Time frame: 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.
2 secondary outcomes
Correlation Between Radiographic Cortical Bone Thickness and Systemic Bone Mineral Density
Time frame: Baseline
Correlation Between Radiographic Cortical Bone Thickness and Systemic T-scores
Time frame: Baseline
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Hemiparesis After Stroke and Dual Energy X-ray Absorptiometry, run by Istanbul Physical Medicine Rehabilitation 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 4 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: looking for participants now, as of the sponsor's last update on 16 Jun 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 Ismet Alkim Ozkan MD (+905356350591, dr.alkimozkan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Proximal Humerus Cortical Bone Thickness Between Paretic and Non-Paretic Sides (time frame: Baseline). 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 16 Jun 2026.