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Recruiting NCT07734506

RELATIONSHIP BETWEEN ULTRASONOGRAPHIC QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS

Observational Stroke Sarcopenia Kinesiophobia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Sarcopenia, Kinesiophobia. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EVALUATION OF THE RELATIONSHIP BETWEEN ULTRASONOGRAPHICALLY MEASURED QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital — Istanbul

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. PMID 25167965
  • Gomes 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. PMID 33244572

Identifiers

NCT: NCT07734506 · 2025/61

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗