NCT07670585

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress23%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 22, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

strokeintercostal muscle thicknessinterkostal muscle thickeningdiaphragm thickness

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ozge Kenis Coskun

CONTACT

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

Locations