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Recruiting NCT07447804

Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients

— Observational Stroke Hemiplegia Following Ischemic Stroke Diaphragm Ultrasonography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Hemiplegia Following Ischemic Stroke, Diaphragm Ultrasonography. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Relationship Between Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients: A Cross-Sectional Study

Overview

The aim of this study is to determine the relationship between diaphragm morphology (diaphragm excursion, end-inspiratory and end-expiratory diaphragm thickness, and thickening fraction) and respiratory muscle strength (maximum inspiratory pressure - MIP and maximum expiratory pressure - MEP) in patients with subacute hemiplegia.

Detailed description

Stroke is a neurological condition that causes multidimensional impairments in motor, sensory, and pulmonary functions and is associated with a high long-term disability burden. After stroke, weakness particularly develops in the diaphragm and intercostal muscles; this results in reduced chest wall movements, ventilatory restriction, and decreased lung volumes. The diaphragm, the primary inspiratory muscle, being positioned higher on the paretic side and exhibiting reduced movement leads to decreased respiratory capacity and impaired cough effectiveness.

Diaphragm ultrasonography is a method that allows noninvasive, reliable, and reproducible evaluation of diaphragm thickness, excursion, and functional changes. The relationship between ultrasound parameters and respiratory muscle strength is of clinical importance in determining the degree of respiratory muscle weakness and setting rehabilitation goals.

Although it is known that post-stroke MIP and MEP values are significantly reduced compared to healthy individuals, the relationship between diaphragm morphology and respiratory muscle strength has been investigated to a limited extent, particularly in the subacute period. Demonstrating this relationship will make an important contribution to planning individualized respiratory rehabilitation in the early period.

Primary outcome measures

  • Mini-Mental State Examination (MMSE) [Time frame: Baseline assessment at a single time point.]
  • Respiratory Muscle Strength (MIP) [Time frame: Baseline assessment at a single time point.]
  • Respiratory Muscle Strength (MEP) [Time frame: Baseline assessment at a single time point.]
  • Diaphragmatic Ultrasonography [Time frame: Baseline assessment at a single time point.]

Eligibility criteria

Inclusion criteria

  • Adults aged 18-80 years
  • Clinical diagnosis of hemiplegia
  • Subacute phase (1-6 months post-onset)
  • Ability to tolerate diaphragm ultrasonography and MIP/MEP measurements
  • MMSE score ≥ 24
  • Adequate level of consciousness and ability to cooperate

Exclusion criteria

  • Respiratory comorbidities such as COPD, asthma, or interstitial lung disease
  • Diaphragmatic paralysis or severe chest wall deformity
  • Acute cardiopulmonary conditions preventing respiratory function testing
  • Severe cognitive impairment that may affect measurements
  • Inability to perform ultrasound assessment due to prior gastric or abdominal surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Fenerbahçe University — Istanbul

Identifiers

NCT: NCT07447804 · FenerbahceUniversity

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗