An observational study in Stroke, Sarcopenia and Kinesiophobia, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 50 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.
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Patients with chronic ischemic stroke who presented to the Physical Medicine and Rehabilitation Clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Quadriceps Muscle Thickness
Bilateral quadriceps femoris muscle thickness (rectus femoris and vastus intermedius) measured by ultrasonography
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
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.
Time frame: 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
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
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.
Time frame: Measured once at the time of study enrollment
Plan to share: 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.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.
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