StrokeNCT07059468
Osteoporosis After Stroke
An observational study of Stroke and Osteoporosis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Osteoporosis
- What is being tested?
- Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA)
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2025to 25 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 44 Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
Who may be able to join
- Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
- Patients with a cognitive status sufficient to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
- Patients with stable medical and psychological status
- Patients willing to participate in the study
Who cannot join
- Presence of hip pathologies that may lead to incorrect measurements in bone mineral density (advanced osteophytic coxarthrosis, heterotrophic ossification, internal fixator, etc.)
- Previous hip, lumbar vertebra fractures (osteoporotic compression fractures)
- History of multiple strokes
- History of concomitant neurological diseases other than stroke (Parkinson, multiple sclerosis, myopathy, etc.)
- History of diseases that may cause secondary osteoporosis (hypogonadism, primary hyperparathyroidism, thyrotoxicosis, malabsorption, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sbü Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi
Ankara, 06800
About this study
Official title: Relationship Between Bilateral Femoral Neck Bone Mineral Density and Clinical Parameters in Stroke Patients
The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.
Read the detailed description
One of the common complications after stroke is secondary osteoporosis that develops due to stroke. The most important event that draws attention to bone health in stroke patients is fractures, the most serious of which in terms of morbidity and mortality are hip fractures. The risk of hip fracture in stroke patients is 2-4 times higher than the normal population due to the decrease in bone mineral density on the plegic side and the increased risk of falling. There is a loss of bone mineral density after stroke. This loss is faster and larger in the early stages of stroke and is greater on the plegic side. The factors affecting this loss of bone mineral density after stroke have not been well defined. The relationship between stroke-related bone mineral density loss and motor function, functional mobility, balance, and muscle mass is not clear. It is important to reveal the changes in bone structure after stroke and the factors affecting this change. The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.
- Conditions
- Stroke, Osteoporosis
- Being tested
- Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA)
- Keywords
- Stroke Osteoporosis
- Medical subject headings
- Stroke, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA)Diagnostic test
Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual X-ray absorptiometry (DXA)
Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method./ Baseline
Measured: baseline
Secondary outcomes (7)
Manual muscle strength measurement/ Muscle strength
Manual muscle strength measurement/ Muscle strength will be evaluated by the Medical Research Council muscle strength scale. This scale is a 6-point scale. (0 = no movement; 1 = tremor of movement; 2 = movement with gravity eliminated; 3 = movement against gravity; 4 = movement against resistance; 5 = full strength
Measured: baseline
Fugl-Meyer Lower Extremity Motor Subscale
This scale evaluates motor function, sensory function, balance, range of motion, and joint pain, and the maximum score is 226. The maximum possible scores on the motor scale are 100 points for the upper (66) and lower (34) extremities, 24 for the sensory scale, 14 for balance, 44 for range of motion, and 44 for joint pain. The motor scale evaluates the mobility of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. Accordingly, 0 indicates that the movement cannot be performed, 1 indicates that it can be performed partially, and 2 indicates that the movement can be performed fully. The motor scale also includes reflex and coordination-speed evaluations (Gladstone et al., 2002). The motor-coordination subscale has a maximum score of 66 points for the upper extremity and a maximum score of 34 points for the lower extremity. Higher scores indicate better motor recovery. In this study, lower extremity motor subscale will be used
Measured: baseline
Functional Ambulation Classification
The Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. It includes six different categories and assesses ambulation status by determining how much support the patient needs while walking, regardless of whether they use assistive devices.
Measured: baseline
Spasticity assessment/ Ashworth graded spasticity from 0 to 4
. Accordingly, 0 indicates normal muscle tone, 1 indicates a slight increase in muscle tone - a feeling of catching, 2 indicates a more pronounced increase in muscle tone (the extremity can be easily moved), 3 indicates a marked increase in muscle tone, and 4 indicates a rigid joint.
Measured: baseline
Berg Balance Scale
The Berg Balance Scale is a widely used clinical test that can reveal a person's static and dynamic balance abilities. Total test score range from 0 (lowest balance) to 56 (highest balance) ability.
Measured: baseline
International Fall Activity Scale
The International Fall Activity Scale is a scale that examines an individual's concerns about the possibility of falling during 16 different activities that do not threaten daily life.The response option ranged from 1-4 depicted by 1 for being not at all concerned, 2 for being somewhat concerned, 3 for being fairly concerned and 4 for being very concerned.
Measured: baseline
Ultrasonographic evaluation
Ultrasonographic evaluation of quadriceps femoris muscle thickness
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start11 Jul 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Engin Koyuncu, Prof., Study director, SBÜ ANKARA GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059468
- Sponsor's protocol ID
- E-34225015 06/001
- Other IDs
- Gaziler
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Bilateral Femoral Neck Bone Mineral Density and Clinical Parameters in Stroke Patients
- ClinicalTrials.gov ID
- NCT07059468
- Acronym / sponsor ID
- E-34225015 06/001
- Conditions
- Stroke, Osteoporosis
- Keywords
- Stroke Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 10 Jul 2025 (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.
The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.
Detailed description
One of the common complications after stroke is secondary osteoporosis that develops due to stroke. The most important event that draws attention to bone health in stroke patients is fractures, the most serious of which in terms of morbidity and mortality are hip fractures. The risk of hip fracture in stroke patients is 2-4 times higher than the normal population due to the decrease in bone mineral density on the plegic side and the increased risk of falling. There is a loss of bone mineral density after stroke. This loss is faster and larger in the early stages of stroke and is greater on the plegic side. The factors affecting this loss of bone mineral density after stroke have not been well defined. The relationship between stroke-related bone mineral density loss and motor function, functional mobility, balance, and muscle mass is not clear. It is important to reveal the changes in bone structure after stroke and the factors affecting this change. The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 44 Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
Key inclusion criteria (4 listed)
- Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
- Patients with a cognitive status sufficient to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
- Patients with stable medical and psychological status
- Patients willing to participate in the study
Key exclusion criteria (5 listed)
- Presence of hip pathologies that may lead to incorrect measurements in bone mineral density (advanced osteophytic coxarthrosis, heterotrophic ossification, internal fixator, etc.)
- Previous hip, lumbar vertebra fractures (osteoporotic compression fractures)
- History of multiple strokes
- History of concomitant neurological diseases other than stroke (Parkinson, multiple sclerosis, myopathy, etc.)
- History of diseases that may cause secondary osteoporosis (hypogonadism, primary hyperparathyroidism, thyrotoxicosis, malabsorption, etc.)
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 |
|---|---|---|
| Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA)Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method | Diagnostic test | – |
Primary outcome
Dual X-ray absorptiometry (DXA)
Time frame: baseline
Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method./ Baseline
7 secondary outcomes
Manual muscle strength measurement/ Muscle strength
Time frame: baseline
Fugl-Meyer Lower Extremity Motor Subscale
Time frame: baseline
Functional Ambulation Classification
Time frame: baseline
Spasticity assessment/ Ashworth graded spasticity from 0 to 4
Time frame: baseline
Berg Balance Scale
Time frame: baseline
International Fall Activity Scale
Time frame: baseline
Ultrasonographic evaluation
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Engin Koyuncu, Prof. study director
SBÜ ANKARA GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
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 Stroke and Osteoporosis, run by Gaziler Physical Medicine and Rehabilitation Education 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 5 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: finished, as of the sponsor's last update on 30 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual X-ray absorptiometry (DXA) (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 30 Mar 2026.