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临床试验/NCT07734506
NCT07734506招募中不适用

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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Quadriceps Muscle Thickness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Quadriceps Muscle Thickness

时间窗: 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

次要结局

  • SARC-F Score(Measured once at the time of study enrollment)
  • Handgrip Strength(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(Measured once at the time of study enrollment)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alperen kolukısaoğlu

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (1)

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