HemiplegiaNCT07812428
Relationship Between Gastrocnemius and Soleus Muscle Thickness Assessed by Ultrasound and Balance and Fear of Falling in Hemiplegic Patients
An observational study of Hemiplegia and Gastrocnemius, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Gastrocnemius, Soleus
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul FTR EAH
Istanbul, Bahcelievler, 34180
About this study
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.
Read more
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
- Medical subject headings
- Hemiplegia
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gastrocnemius and soleus muscle thickness on the paretic and non-paretic sides using ultrasonography (in millimeters, mm)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Aug 2025
- Primary completion30 Oct 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812428
- Sponsor's protocol ID
- 2025-59
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Gastrocnemius and Soleus Muscle Thickness Assessed by Ultrasound and Balance and Fear of Falling in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT07812428
- Acronym / sponsor ID
- 2025-59
- Conditions
- Hemiplegia, Gastrocnemius, Soleus, Ultrasonography, Balance, Falls
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of gastrocnemius and soleus muscle thickness on the paretic and non-paretic sides using ultrasonography (in millimeters, mm)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
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Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia and Gastrocnemius, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gastrocnemius and soleus muscle thickness on the paretic and non-paretic sides using ultrasonography (in millimeters, mm) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.