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Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters

22 juni 2026 bijgewerkt door: Marmara University
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

65

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkije (Türkiye), 34854
        • Marmara Üniversitesi Tıp Fakültesi
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria (Stroke Group):

  • 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.

Exclusion Criteria (Stroke Group):

  • 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.

Inclusion Criteria (Healthy Control Group):

  • Age between 18 and 75 years.
  • Willingness to participate in the study.
  • Provision of written informed consent.

Exclusion Criteria (Healthy Control Group):

  • History of stroke or other neurological disorders.
  • History of chronic respiratory disease (e.g., COPD, asthma).
  • Chest wall deformity.
  • Presence of systemic diseases that may affect muscle function.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
Tijdsspanne: 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.
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parasternal Intercostal Muscle Thickness
Tijdsspanne: Baseline
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.
Baseline
Intercostal Muscle Asymmetry Index
Tijdsspanne: Baseline
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.
Baseline
Relative Hemiplegic Deficit
Tijdsspanne: Baseline
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.
Baseline
Diaphragm Thickening Fraction
Tijdsspanne: Baseline
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.
Baseline
Maximal Inspiratory Pressure (MIP)
Tijdsspanne: Baseline
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.
Baseline
Maximal Expiratory Pressure (MEP)
Tijdsspanne: Baseline
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.
Baseline
Fugl-Meyer Assessment Score
Tijdsspanne: Baseline
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.
Baseline
Berg Balance Scale Score
Tijdsspanne: Baseline
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.
Baseline
Functional Independence Measure (FIM) Score
Tijdsspanne: Baseline
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.
Baseline
Stroke-Specific Quality of Life (SS-QoL) Score
Tijdsspanne: Baseline
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.
Baseline

Medewerkers en onderzoekers

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Sponsor

Marmara University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juli 2026

Primaire voltooiing (Geschat)

15 september 2026

Studie voltooiing (Geschat)

1 oktober 2026

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MarmaraU-FTR-OK-4

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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