Ireland
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Recruiting Observational

Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients

NCT07447804 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-02-26
Last updated
2026-03-05

Condition(s) studied

StrokeHemiplegia Following Ischemic StrokeDiaphragm Ultrasonography

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mini-Mental State Examination (MMSE) — 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.
  • Respiratory Muscle Strength (MIP) — 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.
  • Respiratory Muscle Strength (MEP) — 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.
  • Diaphragmatic Ultrasonography — 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.

Trial sites (1)

FacilityCityRegionStatus
Fenerbahçe University Istanbul Ataşehir Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07447804 on ClinicalTrials.gov ↗ ← All trials in Turkey