StrokeNCT07447804
Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients
An observational study of Stroke and Hemiplegia Following Ischemic Stroke, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia Following Ischemic Stroke, Diaphragm Ultrasonography
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2026to 26 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subacute ischemic hemiplegia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fenerbahçe University
Istanbul, Ataşehir, 34758
Sümeyye Akçay, Asst. Prof., +905424002553, smyye.akcy@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Ischemic Stroke, Diaphragm, Ultrasonography, Pulmonary Funtion, Subacute Hemiplegia, Diaphragm morphology, Respiratory muscle strength, Rehabilitation
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessment at a single time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start26 Feb 2026
- Primary completion26 Jul 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Asst. Prof., Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447804
- Sponsor's protocol ID
- FenerbahceUniversity
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07447804
- Acronym / sponsor ID
- FenerbahceUniversity
- Keywords
- Ischemic Stroke, Diaphragm, Ultrasonography, Pulmonary Funtion, Subacute Hemiplegia, Diaphragm morphology, Respiratory muscle strength, Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 26 Jul 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subacute ischemic hemiplegia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyye Akçay, Asst. Prof. principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiplegia Following Ischemic Stroke, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye Akçay, Asst. Prof. (+905424002553, smyye.akcy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Baseline assessment at a single time point.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.