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NCT Number: NCT07447804

Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diaphragm Ultrasonography Hemiplegia Following Ischemic Stroke Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sümeyye Akçay, Asst. Prof.

CONTACT

[email protected]

+905424002553

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sümeyye Akçay, Asst. Prof.

CONTACT

[email protected]

+905424002553

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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