Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients

March 3, 2026 updated by: Sümeyye Akçay, Fenerbahce University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34758
        • Recruiting
        • Fenerbahçe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subacute ischemic hemiplegia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subacute Hemiplegia Patients
Patients with subacute hemiplegia following stroke will be evaluated. Diaphragm morphology (diaphragm excursion, end-inspiratory and end-expiratory diaphragm thickness, and thickening fraction) will be assessed using ultrasonography. Respiratory muscle strength will be measured by maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). No intervention will be applied. This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination (MMSE)
Time Frame: Baseline assessment at a single time point.
The MMSE, developed by Folstein et al. in 1975, is a widely used, valid, and reliable test for assessing cognitive impairment. The MMSE is a 30-point, multi-item scale that evaluates five domains: orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language (9 points). In 2002, Güngen et al. demonstrated that the Turkish version of the MMSE is valid and reliable.
Baseline assessment at a single time point.
Diaphragmatic Ultrasonography
Time Frame: Baseline assessment at a single time point.

Diaphragm excursion will be assessed using M-mode ultrasonography, and diaphragm thickness and contractility will be measured using B-mode ultrasonography.

Patients will be evaluated in the supine position. Diaphragm thickness will be measured at end-expiration from the 9th intercostal space along the anterior axillary line using a 7-MHz linear transducer. Diaphragm motion during normal and deep breathing will be assessed with a 3.5-MHz curved transducer from the right hemidiaphragm.

The difference between inspiratory and expiratory measurements will be analyzed, and diaphragm thickening fraction will be calculated.
Baseline assessment at a single time point.
Respiratory Muscle Strength (MIP)
Time Frame: Baseline assessment at a single time point.

Respiratory muscle strength will be measured using an electronic, portable intraoral pressure device (MicroRPM, Micro Medical; United Kingdom). All measurements will be performed in the seated position. The nasal airway will be occluded using a nose clip, and an appropriate mouthpiece will be used.

For MIP assessment, the patient will first perform a maximal expiration before placing the device in the mouth, followed by a maximal inspiratory effort (Müller maneuver) at maximum speed sustained for 1-3 seconds.

This maneuver will be repeated three times, and the highest value will be recorded in cmH₂O.
Baseline assessment at a single time point.
Respiratory Muscle Strength (MEP)
Time Frame: Baseline assessment at a single time point.

Respiratory muscle strength will be measured using an electronic, portable intraoral pressure device (MicroRPM, Micro Medical; United Kingdom). All measurements will be performed in the seated position. The nasal airway will be occluded using a nose clip, and an appropriate mouthpiece will be used.

For MEP assessment, the patient will first perform a maximal inspiration before placing the device in the mouth, followed by a maximal expiratory effort (Valsalva maneuver) at maximum speed sustained for 1-3 seconds.

This maneuver will be repeated three times, and the highest value will be recorded in cmH₂O.
Baseline assessment at a single time point.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenerbahce University

Investigators

  • Principal Investigator: Sümeyye Akçay, Asst. Prof., Fenerbahçe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

July 26, 2026

Study Completion (Estimated)

September 26, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FenerbahceUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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