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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

65

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Türkei (türkiye)
    • Maltepe
      • Istanbul, Maltepe, Türkei (türkiye), 34854
        • Marmara Üniversitesi Tıp Fakültesi
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parasternal Intercostal Muscle Thickening Fraction (ICTf)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parasternal Intercostal Muscle Thickness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

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Sponsor

Marmara University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

15. September 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MarmaraU-FTR-OK-4

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