Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients

NCT07447804 | Recruiting

• 1 other identifier: FenerbahceUniversity
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiplegia Following Ischemic Stroke; Diaphragm Ultrasonography

Keywords

Ischemic Stroke; Diaphragm; Ultrasonography; Pulmonary Funtion; Subacute Hemiplegia; Diaphragm morphology; Respiratory muscle strength; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline assessment at a single time point.

• 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.

  Baseline assessment at a single time point.

• 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.

  Baseline assessment at a single time point.

• 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.

  Baseline assessment at a single time point.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subacute ischemic hemiplegia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sümeyye Akçay, Asst. Prof.

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Akçay, Asst. Prof.

CONTACT

+905424002553; smyye.akcy@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: February 26, 2026
• Primary Completion: July 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)