StrokeNCT07670585
Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters
An observational study of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the morphological and functional characteristics of parasternal intercostal muscles in patients with stroke using ultrasonography. Parasternal intercostal muscle thickness and thickening fraction will be assessed on both the hemiplegic and non-hemiplegic sides. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 1 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with a history of ischemic or hemorrhagic stroke attending the outpatient Physical Medicine and Rehabilitation clinic of Marmara University, and age-eligible healthy volunteers recruited as controls.
Who may be able to join
- Age between 18 and 75 years.
- History of ischemic or hemorrhagic stroke.
- Ability to understand and comply with study procedures.
- Provision of written informed consent.
- Age between 18 and 75 years.
- Willingness to participate in the study.
- Provision of written informed consent.
Who cannot join
- Presence of acute or chronic pulmonary disease.
- History of thoracic or abdominal surgery.
- Presence of another neuromuscular disorder.
- Aphasia or cognitive impairment preventing participation in assessments.
- Active malignancy.
- History of stroke or other neurological disorders.
Show all 9Show fewer
- History of chronic respiratory disease (e.g., COPD, asthma).
- Chest wall deformity.
- Presence of systemic diseases that may affect muscle function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ozge Kenis Coskun contact
Turkey (Türkiye)1 site
Marmara Üniversitesi Tıp Fakültesi
Istanbul, Maltepe, 34854
Secretary General Secretary, +90 2166254545, ozgekenis@gmail.com
About this study
The aim of this study is to evaluate the morphological and functional characteristics of parasternal intercostal muscles in patients with stroke using ultrasonography. Parasternal intercostal muscle thickness and thickening fraction will be assessed on both the hemiplegic and non-hemiplegic sides. The relationship between ultrasonographic findings and respiratory muscle strength, motor function, balance, functional independence, and quality of life will also be investigated. A healthy control group will be included to establish reference values and enable comparative analyses.
Read the detailed description
Stroke frequently leads to respiratory muscle dysfunction due to impaired central motor control. Although diaphragm involvement after stroke has been extensively investigated, there is limited evidence regarding the morphological and functional characteristics of extra-diaphragmatic inspiratory muscles, particularly the parasternal intercostal muscles.
The primary objective of this study is to evaluate parasternal intercostal muscle morphology and contractility in individuals with stroke using ultrasonography. Parasternal intercostal muscle thickness will be measured at end-tidal expiration and maximal inspiration, and intercostal muscle thickening fraction (ICTf) will be calculated as an indicator of muscle contractility. Measurements will be obtained bilaterally, allowing comparison between the hemiplegic and non-hemiplegic sides.
In addition, diaphragm thickness and diaphragm thickening fraction will be assessed using ultrasonography. Respiratory muscle strength will be evaluated by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements according to ATS/ERS recommendations. Pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC ratio will also be performed.
Clinical outcomes including motor impairment, balance, functional independence, and stroke-specific quality of life will be assessed using the Fugl-Meyer Assessment, Berg Balance Scale, Functional Independence Measure (FIM), and Stroke-Specific Quality of Life Scale (SS-QoL), respectively.
A healthy control group matched for age, sex, and body mass index will be included to establish reference values for parasternal intercostal muscle ultrasonographic measurements and to allow comparative analyses between stroke patients and healthy individuals.
The study is designed as a single-center, controlled cross-sectional observational study. A minimum of 40 individuals with stroke and 25 healthy volunteers will be enrolled. Associations between ultrasonographic respiratory muscle measurements and clinical parameters will be analyzed to improve understanding of respiratory muscle involvement after stroke and its relationship with functional outcomes.
- Conditions
- Stroke
- Keywords
- stroke, intercostal muscle thickness, interkostal muscle thickening, diaphragm thickness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Stroke Patients | Adults aged 18-75 years with a history of ischemic or hemorrhagic stroke who meet the study eligibility criteria. A minimum of 40 participants will be enrolled in this group. | |
| Group 2: Healthy Controls | Age-eligible healthy volunteers without a history of stroke, neurological disease, chronic respiratory disease, chest wall deformity, or systemic disease affecting muscle function. A minimum of 25 participants will be enrolled in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
Ultrasonographic assessment of parasternal intercostal muscle contractility. Thickening fraction will be calculated as: (Inspiratory Thickness - Expiratory Thickness) / Expiratory Thickness × 100. Higher values indicate greater inspiratory muscle contractile activity. Comparison will be performed between the hemiplegic and non-hemiplegic sides.
Measured: Baseline
Secondary outcomes (10)
Parasternal Intercostal Muscle Thickness
Ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.
Measured: Baseline
Intercostal Muscle Asymmetry Index
Intercostal Muscle Asymmetry Index (AI) is a normalized measure of side-to-side differences in parasternal intercostal muscle contractility. The asymmetry index is calculated using the formula |TF₁ - TF₂| / [(TF₁ + TF₂)/2] × 100, where TF represents the intercostal muscle thickening fraction measured by ultrasonography. Higher values indicate greater asymmetry between the two sides, whereas lower values indicate more symmetrical intercostal muscle function.
Measured: Baseline
Relative Hemiplegic Deficit
Relative Hemiplegic Deficit is a measure of the reduction in parasternal intercostal muscle contractility on the hemiplegic side relative to the non-hemiplegic side in individuals with stroke. It is calculated using the formula [(TFnon-hemiplegic - TFhemiplegic) / TFnon-hemiplegic] × 100, where TF represents the intercostal muscle thickening fraction measured by ultrasonography. Higher values indicate a greater functional deficit of the hemiplegic side, while lower values indicate more preserved intercostal muscle function.
Measured: Baseline
Diaphragm Thickening Fraction
Diaphragm contractility assessed by ultrasonography. Thickening fraction is calculated as [(Thickness at maximal inspiration - Thickness at end-expiration) / Thickness at end-expiration] × 100. Higher values indicate greater diaphragm contractile function.
Measured: Baseline
Maximal Inspiratory Pressure (MIP)
Maximum inspiratory pressure (MIP) is a measurement that evaluates the strength of the inspiratory muscles. This test measures the negative pressure created when a person breathes in at maximum effort. MIP assesses the strength of respiratory muscles, such as the diaphragm and intercostal muscles, and is used to diagnose conditions characterized by respiratory muscle weakness.
Measured: Baseline
Maximal Expiratory Pressure (MEP)
Maximum expiratory pressure (MEP) is a measurement that evaluates the strength of the expiratory muscles. This test measures the positive pressure generated when a person exhales with maximum effort. MEP assesses the strength of expiratory muscles, including the abdominal and internal intercostal muscles, and is commonly used to evaluate respiratory muscle function and identify conditions associated with expiratory muscle weakness. Higher values indicate greater expiratory muscle strength.
Measured: Baseline
Fugl-Meyer Assessment Score
The Fugl-Meyer Assessment (FMA) is a stroke-specific impairment scale used to evaluate motor recovery after stroke. The motor domain score ranges from 0 to 100 points, with higher scores indicating better motor function and less motor impairment.
Measured: Baseline
Berg Balance Scale Score
The Berg Balance Scale (BBS) consists of 14 tasks assessing static and dynamic balance. Scores range from 0 to 56 points. Higher scores indicate better balance performance and lower fall risk, whereas lower scores indicate greater balance impairment.
Measured: Baseline
Functional Independence Measure (FIM) Score
The Functional Independence Measure assesses the level of disability and functional independence in activities of daily living. Total scores range from 18 to 126 points. Higher scores indicate greater independence and lower levels of assistance required.
Measured: Baseline
Stroke-Specific Quality of Life (SS-QoL) Score
Stroke-Specific Quality of Life Scale (SS-QoL) is used to assess the life expectancy of a stroke survivor. It is specifically designed for individuals who have had a stroke. Both personal and psychosocial effects are assessed collectively. Scores range from 49-245. Higher scores indicate better functioning.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670585
- Sponsor's protocol ID
- MarmaraU-FTR-OK-4
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters
- ClinicalTrials.gov ID
- NCT07670585
- Acronym / sponsor ID
- MarmaraU-FTR-OK-4
- Conditions
- Stroke
- Keywords
- stroke, intercostal muscle thickness, interkostal muscle thickening, diaphragm thickness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Jun 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.
The aim of this study is to evaluate the morphological and functional characteristics of parasternal intercostal muscles in patients with stroke using ultrasonography. Parasternal intercostal muscle thickness and thickening fraction will be assessed on both the hemiplegic and non-hemiplegic sides. The relationship between ultrasonographic findings and respiratory muscle strength, motor function, balance, functional independence, and quality of life will also be investigated. A healthy control group will be included to establish reference values and enable comparative analyses.
Detailed description
Stroke frequently leads to respiratory muscle dysfunction due to impaired central motor control. Although diaphragm involvement after stroke has been extensively investigated, there is limited evidence regarding the morphological and functional characteristics of extra-diaphragmatic inspiratory muscles, particularly the parasternal intercostal muscles.
The primary objective of this study is to evaluate parasternal intercostal muscle morphology and contractility in individuals with stroke using ultrasonography. Parasternal intercostal muscle thickness will be measured at end-tidal expiration and maximal inspiration, and intercostal muscle thickening fraction (ICTf) will be calculated as an indicator of muscle contractility. Measurements will be obtained bilaterally, allowing comparison between the hemiplegic and non-hemiplegic sides.
In addition, diaphragm thickness and diaphragm thickening fraction will be assessed using ultrasonography. Respiratory muscle strength will be evaluated by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements according to ATS/ERS recommendations. Pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC ratio will also be performed.
Clinical outcomes including motor impairment, balance, functional independence, and stroke-specific quality of life will be assessed using the Fugl-Meyer Assessment, Berg Balance Scale, Functional Independence Measure (FIM), and Stroke-Specific Quality of Life Scale (SS-QoL), respectively.
A healthy control group matched for age, sex, and body mass index will be included to establish reference values for parasternal intercostal muscle ultrasonographic measurements and to allow comparative analyses between stroke patients and healthy individuals.
The study is designed as a single-center, controlled cross-sectional observational study. A minimum of 40 individuals with stroke and 25 healthy volunteers will be enrolled. Associations between ultrasonographic respiratory muscle measurements and clinical parameters will be analyzed to improve understanding of respiratory muscle involvement after stroke and its relationship with functional outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Stroke Patients | – | –Adults aged 18-75 years with a history of ischemic or hemorrhagic stroke who meet the study eligibility criteria. A minimum of 40 participants will be enrolled in this group. |
| Group 2: Healthy Controls | – | –Age-eligible healthy volunteers without a history of stroke, neurological disease, chronic respiratory disease, chest wall deformity, or systemic disease affecting muscle function. A minimum of 25 participants will be enrolled in this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a history of ischemic or hemorrhagic stroke attending the outpatient Physical Medicine and Rehabilitation clinic of Marmara University, and age-eligible healthy volunteers recruited as controls.
Key inclusion criteria (7 listed)
- Age between 18 and 75 years.
- History of ischemic or hemorrhagic stroke.
- Ability to understand and comply with study procedures.
- Provision of written informed consent.
- Age between 18 and 75 years.
Key exclusion criteria (9 listed)
- Presence of acute or chronic pulmonary disease.
- History of thoracic or abdominal surgery.
- Presence of another neuromuscular disorder.
- Aphasia or cognitive impairment preventing participation in assessments.
- Active malignancy.
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
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
Time frame: Baseline
Ultrasonographic assessment of parasternal intercostal muscle contractility. Thickening fraction will be calculated as: (Inspiratory Thickness - Expiratory Thickness) / Expiratory Thickness × 100. Higher values indicate greater inspiratory muscle contractile activity. Comparison will be performed between the hemiplegic and non-hemiplegic sides.
10 secondary outcomes
Parasternal Intercostal Muscle Thickness
Time frame: Baseline
Intercostal Muscle Asymmetry Index
Time frame: Baseline
Relative Hemiplegic Deficit
Time frame: Baseline
Diaphragm Thickening Fraction
Time frame: Baseline
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline
Maximal Expiratory Pressure (MEP)
Time frame: Baseline
Fugl-Meyer Assessment Score
Time frame: Baseline
Berg Balance Scale Score
Time frame: Baseline
Functional Independence Measure (FIM) Score
Time frame: Baseline
Stroke-Specific Quality of Life (SS-QoL) Score
Time frame: Baseline
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ozge Kenis Coskun contact
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 Stroke, run by Marmara University 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Jun 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?
Contact Oguzhan Kasimoglu (+905448911835, kasimogluoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasternal Intercostal Muscle Thickening Fraction (ICTf) (time frame: Baseline). 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 26 Jun 2026.