StrokeQMSKNCT07734506
RELATIONSHIP BETWEEN ULTRASONOGRAPHIC QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS
An observational study of Stroke and Sarcopenia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the relationship between ultrasonography-measured quadriceps muscle thickness and the sarcopenia markers SARC-F questionnaire and handgrip strength in patients diagnosed with ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Sarcopenia, Kinesiophobia
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Aug 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic ischemic stroke who presented to the Physical Medicine and Rehabilitation Clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Who may be able to join
- Chronic stroke duration between 6 months and 2 years
- Ischemic stroke type
- Age between 40-80 years
- Brunnstrom lower extremity motor stage ≥3, ambulatory
- Provision of written informed consent
Who cannot join
- Hemorrhagic stroke
- Stroke onset more than 2 years prior
- Inflammatory arthritis or other rheumatologic disease
- History of knee trauma
- Pre-stroke neurological gait disorder
- Recurrent stroke
- Lower extremity amputation
- Knee joint contracture
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 and Rehabilitation Training and Research Hospital
Istanbul, Istanbul, 34180
ALPEREN KOLUKISAOĞLU, MD, +905387911854, drkolukisaoglu@gmail.com
ALPEREN KOLUKISAOĞLU, MD
About this study
Official title: EVALUATION OF THE RELATIONSHIP BETWEEN ULTRASONOGRAPHICALLY MEASURED QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS
The aim of this study is to evaluate the relationship between ultrasonography-measured quadriceps muscle thickness and the sarcopenia markers SARC-F questionnaire and handgrip strength in patients diagnosed with ischemic stroke. In addition, the relationship between quadriceps muscle thickness and the level of kinesiophobia will be quantitatively assessed.
This study is a cross-sectional clinical study conducted between August 1, 2025, and August 1, 2026, at the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences İstanbul Physical Medicine and Rehabilitation Training and Research Hospital. Fifty volunteer participants with ischemic stroke and a lower-extremity Brunnstrom motor stage of 3 or higher, who presented to the clinic during the study period, were included.
Read more
Bilateral quadriceps femoris muscle thickness, including the rectus femoris and vastus intermedius muscles, was measured using ultrasonography. The SARC-F questionnaire was used to assess sarcopenia risk, handgrip strength measurement was used to evaluate muscle strength, and the Tampa Scale for Kinesiophobia was used to determine the level of kinesiophobia. Motor recovery stage was assessed using the Brunnstrom Staging system; motor and cognitive independence were assessed using the Functional Independence Measure; walking independence was assessed using the Functional Ambulation Scale; and independence in activities of daily living was assessed using the Barthel Index of Activities of Daily Living.
Because balance impairment, muscle weakness, and limited mobility are common after stroke, physical performance tests may be difficult to administer safely and consistently in this patient population. Therefore, the relationship between quadriceps muscle thickness and physical performance tests was not evaluated in this study. The Chair Stand Test, which requires repeated sit-to-stand movements as well as adequate balance and lower-extremity muscle strength, was also not included because it may increase the risk of falls in patients with limited mobility.
This study aims to demonstrate the clinical potential of ultrasonography in the assessment of post-stroke sarcopenia and to support a more holistic approach to stroke rehabilitation planning that considers both physical and psychological factors.
Read the detailed description
Sarcopenia is a common consequence of stroke, resulting from immobility, decreased physical activity, and impaired neuromuscular control. This process particularly affects the lower extremity muscles, limiting physical independence and reducing the effectiveness of rehabilitation. The structural properties of lower extremity muscles are considered an important determinant of a patient's functional capacity, and the quadriceps femoris muscle plays a central role in essential motor tasks such as walking and transferring, given its involvement in knee extension and hip flexion.
Ultrasonographic assessment of quadriceps muscle thickness offers a non-invasive and practical method for obtaining quantitative and objective data on muscle morphology, providing a clinically valuable advantage over more resource-intensive imaging modalities such as DXA, bioelectrical impedance analysis (BIA), CT, or MRI. While handgrip strength and the SARC-F questionnaire are widely used as initial screening tools for possible sarcopenia, a definitive diagnosis requires muscle mass quantification, for which ultrasonography has become an increasingly used method in recent years.
This study does not classify patients according to sarcopenia status; instead, it evaluates the extent to which handgrip strength and SARC-F scores align with ultrasonographically measured quadriceps thickness. This relationship has been studied in other patient populations but remains less explored specifically in stroke survivors, which is why this population was selected.
In addition to physical determinants of musculoskeletal health, psychological factors are also considered relevant. Kinesiophobia-an irrational fear of movement-is frequently observed after stroke and may limit participation in physical activity, reinforcing a cycle of inactivity and further muscle deterioration. This study therefore also examines the potential association between kinesiophobia and quadriceps muscle thickness in chronic stroke patients, aiming to provide clinically relevant insight into how muscle structure and psychological status may interact, and to support a more individualized and multidisciplinary approach to post-stroke rehabilitation planning.
- Conditions
- Stroke, Sarcopenia, Kinesiophobia
- Keywords
- Quadriceps Muscle Thickness, Ultrasonography, Sarcopenia, SARC-F, Handgrip Strength, Kinesiophobia, Stroke Rehabilitation
- Medical subject headings
- Stroke, Sarcopenia, Kinesiophobia
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 |
|---|---|---|
| Ischemic Stroke Patients | Fifty volunteer participants diagnosed with ischemic stroke, admitted to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between August 1, 2025 and August 1, 2026, were included. Inclusion criteria were: chronic stroke duration between 6 months and 2 years, ischemic stroke type, age between 40-80 years, Brunnstrom lower extremity motor stage ≥3 with ambulatory status, and provision of written informed consent. Patients with hemorrhagic stroke, stroke onset more than 2 years prior, inflammatory arthritis or other rheumatologic disease, history of knee trauma, pre-stroke neurological gait disorder, recurrent stroke, lower extremity amputation, or knee joint contracture were excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Thickness
Bilateral quadriceps femoris muscle thickness (rectus femoris and vastus intermedius) measured by ultrasonography
Measured: Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the mean value was recorded as the outcome value
Secondary outcomes (3)
SARC-F Score
Sarcopenia risk was screened using the SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls) questionnaire, a self-reported 5-item tool. Total score ranges from 0 to 10; higher scores indicate greater risk of sarcopenia.
Measured: Measured once at the time of study enrollment
Handgrip Strength
Handgrip strength was measured using a JAMAR hand dynamometer, expressed in kilograms, as an indicator of functional muscle strength. Higher values indicate greater muscle strength. According to EWGSOP2 criteria, low muscle strength is defined as grip strength <27 kg in men and <16 kg in women; values at or above these thresholds are considered normal. There is no fixed maximum value, as grip strength is an open-ended continuous measure
Measured: Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the highest value was recorded as the outcome value
Tampa Scale for Kinesiophobia Score
Kinesiophobia level was assessed using the Tampa Scale for Kinesiophobia (TSK), a self-reported 17-item questionnaire measuring fear of movement/re-injury. Total score ranges from 17 to 68; higher scores indicate greater kinesiophobia.
Measured: Measured once at the time of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alperen kolukısaoğlu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- ALPEREN KOLUKISAOĞLU, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research HospitalNUR KESİKTAŞ, MD, Professor, Study chair, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734506
- Sponsor's protocol ID
- 2025/61
- Acronym
- QMSK
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as there is currently no plan or infrastructure in place for external data sharing. The data collected in this study will be used solely for the purposes of this thesis research and any related publications. No mechanism for de-identified data transfer or a data sharing agreement has been established. This decision may be reconsidered in the future if a formal data sharing framework becomes available at the institutional level.
Publications
Cigercioglu N, Bazancir Apaydin Z, Apaydin H, Guney H. The relationship between kinesiophobia and muscle architectural characteristics and functional tests in women with knee osteoarthritis: an analytical study. Turkiye Klinikleri Journal of Health Sciences. 2024;9(1). doi:10.5336/healthsci.2024-101654.
Rech A, Radaelli R, Goltz FR, da Rosa LH, Schneider CD, Pinto RS. Echo intensity is negatively associated with functional capacity in older women. Age (Dordr). 2014;36(5):9708. doi: 10.1007/s11357-014-9708-2. Epub 2014 Aug 29.
PubMed 25167965Gomes TLN, Borges TC, Pichard C, Pimentel GD. Correlation between SARC-F Score and Ultrasound-Measured Thigh Muscle Thickness in Older Hospitalized Cancer Patients. J Nutr Health Aging. 2020;24(10):1128-1130. doi: 10.1007/s12603-020-1524-z.
PubMed 33244572
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE RELATIONSHIP BETWEEN ULTRASONOGRAPHICALLY MEASURED QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS
- ClinicalTrials.gov ID
- NCT07734506
- Acronym / sponsor ID
- QMSK / 2025/61
- Conditions
- Stroke, Sarcopenia, Kinesiophobia
- Keywords
- Quadriceps Muscle Thickness, Ultrasonography, Sarcopenia, SARC-F, Handgrip Strength, Kinesiophobia, Stroke Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 29 Jul 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.
The aim of this study is to evaluate the relationship between ultrasonography-measured quadriceps muscle thickness and the sarcopenia markers SARC-F questionnaire and handgrip strength in patients diagnosed with ischemic stroke. In addition, the relationship between quadriceps muscle thickness and the level of kinesiophobia will be quantitatively assessed.
This study is a cross-sectional clinical study conducted between August 1, 2025, and August 1, 2026, at the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences İstanbul Physical Medicine and Rehabilitation Training and Research Hospital. Fifty volunteer participants with ischemic stroke and a lower-extremity Brunnstrom motor stage of 3 or higher, who presented to the clinic during the study period, were included.
Bilateral quadriceps femoris muscle thickness, including the rectus femoris and vastus intermedius muscles, was measured using ultrasonography. The SARC-F questionnaire was used to assess sarcopenia risk, handgrip strength measurement was used to evaluate muscle strength, and the Tampa Scale for Kinesiophobia was used to determine the level of kinesiophobia. Motor recovery stage was assessed using the Brunnstrom Staging system; motor and cognitive independence were assessed using the Functional Independence Measure; walking independence was assessed using the Functional Ambulation Scale; and independence in activities of daily living was assessed using the Barthel Index of Activities of Daily Living.
Because balance impairment, muscle weakness, and limited mobility are common after stroke, physical performance tests may be difficult to administer safely and consistently in this patient population. Therefore, the relationship between quadriceps muscle thickness and physical performance tests was not evaluated in this study. The Chair Stand Test, which requires repeated sit-to-stand movements as well as adequate balance and lower-extremity muscle strength, was also not included because it may increase the risk of falls in patients with limited mobility.
This study aims to demonstrate the clinical potential of ultrasonography in the assessment of post-stroke sarcopenia and to support a more holistic approach to stroke rehabilitation planning that considers both physical and psychological factors.
Detailed description
Sarcopenia is a common consequence of stroke, resulting from immobility, decreased physical activity, and impaired neuromuscular control. This process particularly affects the lower extremity muscles, limiting physical independence and reducing the effectiveness of rehabilitation. The structural properties of lower extremity muscles are considered an important determinant of a patient's functional capacity, and the quadriceps femoris muscle plays a central role in essential motor tasks such as walking and transferring, given its involvement in knee extension and hip flexion.
Ultrasonographic assessment of quadriceps muscle thickness offers a non-invasive and practical method for obtaining quantitative and objective data on muscle morphology, providing a clinically valuable advantage over more resource-intensive imaging modalities such as DXA, bioelectrical impedance analysis (BIA), CT, or MRI. While handgrip strength and the SARC-F questionnaire are widely used as initial screening tools for possible sarcopenia, a definitive diagnosis requires muscle mass quantification, for which ultrasonography has become an increasingly used method in recent years.
This study does not classify patients according to sarcopenia status; instead, it evaluates the extent to which handgrip strength and SARC-F scores align with ultrasonographically measured quadriceps thickness. This relationship has been studied in other patient populations but remains less explored specifically in stroke survivors, which is why this population was selected.
In addition to physical determinants of musculoskeletal health, psychological factors are also considered relevant. Kinesiophobia-an irrational fear of movement-is frequently observed after stroke and may limit participation in physical activity, reinforcing a cycle of inactivity and further muscle deterioration. This study therefore also examines the potential association between kinesiophobia and quadriceps muscle thickness in chronic stroke patients, aiming to provide clinically relevant insight into how muscle structure and psychological status may interact, and to support a more individualized and multidisciplinary approach to post-stroke rehabilitation planning.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke Patients | – | –Fifty volunteer participants diagnosed with ischemic stroke, admitted to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between August 1, 2025 and August 1, 2026, were included. Inclusion criteria were: chronic stroke duration between 6 months and 2 years, ischemic stroke type, age between 40-80 years, Brunnstrom lower extremity motor stage ≥3 with ambulatory status, and provision of written informed consent. Patients with hemorrhagic stroke, stroke onset more than 2 years prior, inflammatory arthritis or other rheumatologic disease, history of knee trauma, pre-stroke neurological gait disorder, recurrent stroke, lower extremity amputation, or knee joint contracture were excluded. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic ischemic stroke who presented to the Physical Medicine and Rehabilitation Clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Key inclusion criteria (5 listed)
- Chronic stroke duration between 6 months and 2 years
- Ischemic stroke type
- Age between 40-80 years
- Brunnstrom lower extremity motor stage ≥3, ambulatory
- Provision of written informed consent
Key exclusion criteria (8 listed)
- Hemorrhagic stroke
- Stroke onset more than 2 years prior
- Inflammatory arthritis or other rheumatologic disease
- History of knee trauma
- Pre-stroke neurological gait disorder
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
Quadriceps Muscle Thickness
Time frame: Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the mean value was recorded as the outcome value
Bilateral quadriceps femoris muscle thickness (rectus femoris and vastus intermedius) measured by ultrasonography
3 secondary outcomes
SARC-F Score
Time frame: Measured once at the time of study enrollment
Handgrip Strength
Time frame: Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the highest value was recorded as the outcome value
Tampa Scale for Kinesiophobia Score
Time frame: Measured once at the time of study enrollment
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 29 Jul 2026.
- BackgroundCigercioglu N, Bazancir Apaydin Z, Apaydin H, Guney H. The relationship between kinesiophobia and muscle architectural characteristics and functional tests in women with knee osteoarthritis: an analytical study. Turkiye Klinikleri Journal of Health Sciences. 2024;9(1). doi:10.5336/healthsci.2024-101654.
- Background: PubMed 25167965Rech A, Radaelli R, Goltz FR, da Rosa LH, Schneider CD, Pinto RS. Echo intensity is negatively associated with functional capacity in older women. Age (Dordr). 2014;36(5):9708. doi: 10.1007/s11357-014-9708-2. Epub 2014 Aug 29.
- Background: PubMed 33244572Gomes TLN, Borges TC, Pichard C, Pimentel GD. Correlation between SARC-F Score and Ultrasound-Measured Thigh Muscle Thickness in Older Hospitalized Cancer Patients. J Nutr Health Aging. 2020;24(10):1128-1130. doi: 10.1007/s12603-020-1524-z.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as there is currently no plan or infrastructure in place for external data sharing. The data collected in this study will be used solely for the purposes of this thesis research and any related publications. No mechanism for de-identified data transfer or a data sharing agreement has been established. This decision may be reconsidered in the future if a formal data sharing framework becomes available at the institutional level.
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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.
ALPEREN KOLUKISAOĞLU, MD principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
NUR KESİKTAŞ, MD, Professor study chair
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
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 Sarcopenia, 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 5 inclusion and 8 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 29 Jul 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 ALPEREN KOLUKISAOĞLU, MD (+905387911854, drkolukisaoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Thickness (time frame: Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the mean value was recorded as the outcome value). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734506, which also lists 3 linked publications.
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 29 Jul 2026.