Ultrasonographic Evaluation of Morphological and Functional Characteristics of Intercostal Muscles in Stroke Patients and Their Relationship With Clinical Parameters
1 other identifier
observational
65
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
June 26, 2026
June 1, 2026
2 months
June 22, 2026
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (10)
Parasternal Intercostal Muscle Thickness
Baseline
Intercostal Muscle Asymmetry Index
Baseline
Relative Hemiplegic Deficit
Baseline
Diaphragm Thickening Fraction
Baseline
Maximal Inspiratory Pressure (MIP)
Baseline
- +5 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Age between 18 and 75 years.
- Willingness to participate in the study.
- Provision of written informed consent.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara Üniversitesi Tıp Fakültesi
Istanbul, Maltepe, 34854, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
June 26, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share