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OpenTrials
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NCT Number: NCT07812428

Relationship Between Gastrocnemius and Soleus Muscle Thickness Assessed by Ultrasound and Balance and Fear of Falling in Hemiplegic Patients

Structural and functional changes occurring in the lower extremity muscles of hemiplegic stroke patients play a decisive role in gait ability, balance impairment, and fall risk. In this context, the relationship between muscle architecture parameters such as the thickness of the gastrocnemius and soleus muscles and functional performance is being investigated. Ultrasonography is a reliable and accessible method for the non-invasive assessment of muscle thickness.

Yakut et al. (2024) reported that in acute stroke patients, particularly the thickness and cross-sectional area of the soleus muscle were significantly associated with the Berg Balance Scale, Single-Leg Stance Test, and Timed Up and Go Test. In the same study, it was also shown that the thickness of the gastrocnemius muscle on the non-paretic side was related to balance.

Onat et al. (2022) demonstrated correlations between lower extremity muscle architecture and measures such as the Timed Up and Go Test, Fugl-Meyer Lower Extremity Assessment, and Functional Independence Measure, emphasizing that the gastrocnemius and soleus muscles play a determining role in motor and functional level.

Suh et al. (2022) reported that trunk muscle thickness was significantly associated with the Berg Balance Scale, Functional Ambulation Scale, and Functional Reach Test.

In this study, gastrocnemius and soleus muscle thickness will be evaluated using ultrasonography in subacute and chronic stroke patients, and their relationship with balance (Berg Balance Scale), mobility (Timed Up and Go Test and Functional Ambulation Scale), and fear of falling (Falls Efficacy Scale International) will be investigated. The study aims to provide original contributions to the literature by revealing the interaction between muscle architecture and both physical and psychosocial outcomes, and to support the development of targeted rehabilitation strategies for individuals at high risk of falling.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul FTR EAH

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals diagnosed with hemiplegia confirmed by clinical and imaging methods Patients in the subacute-chronic phase, at least 1 month post-stroke Adults aged 18 years and older Individuals able to stand and/or walk a few steps (at least FAS ≥ 2) Individuals scoring 24 or higher on the Mini-Mental State Examination Individuals who agree to participate in the study

Exclusion criteria

Individuals with gait or balance limitations due to other neurological disorders Individuals unable to tolerate physical testing due to severe cardiac disease, active infection, malignancy, or other systemic diseases Patients with skin lesions or amputations preventing ultrasound assessment Individuals with a history of prior lower extremity orthopedic surgery, prosthesis use, or musculoskeletal abnormalities Individuals with cognitive or communication impairments that prevent understanding of instructions or participation Receipt of botulinum toxin injection within the last 3 months Presence of spasticity ≥ 3 on the Modified Ashworth Scale (MAS) in the muscles to be assessed

Treatment and study plan

Primary outcomes

  1. Measurement of gastrocnemius and soleus muscle thickness on the paretic and non-paretic sides using ultrasonography (in millimeters, mm)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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