Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFenerbahce University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Subacute ischemic hemiplegia
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
38 Participants
are grouped into 1 trial groupGroup A: Subacute Hemiplegia Patients
Trial outcomes
Primary outcomes
1
Mini-Mental State Examination (MMSE)
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.
Time frame
Baseline assessment at a single time point.2
Respiratory Muscle Strength (MIP)
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.
Time frame
Baseline assessment at a single time point.3
Respiratory Muscle Strength (MEP)
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.
Time frame
Baseline assessment at a single time point.4
Diaphragmatic Ultrasonography
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.
Time frame
Baseline assessment at a single time point.Sponsors and contacts
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Source ClinicalTrials.gov