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

NCT07812428 | Active Not Recruiting

• 1 other identifier: 2025-59
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Gastrocnemius; Soleus; Ultrasonography; Balance; Falls

Outcome Measures

Primary Outcomes (1)

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

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 39 individuals diagnosed with hemiplegia who present to the University of Health Sciences Istanbul Physical Therapy and Rehabilitation Training and Research Hospital SUAM, Physical Medicine and Rehabilitation Hospital, will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul FTR EAH

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

TU (1)