Diaphragm structure and breathing muscle strength in people with recent hemiplegia
The Relationship Between Diaphragm Morphology and Respiratory Muscle Strength in Subacute Hemiplegic Patients: A Cross-Sectional Study
Fenerbahce University · NCT07447804
This project will see if diaphragm ultrasound measurements relate to breathing muscle strength in adults 1–6 months after an ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fenerbahce University (other) |
| Locations | 1 site (Istanbul, Ataşehir) |
| Trial ID | NCT07447804 on ClinicalTrials.gov |
What this trial studies
This observational study uses diaphragm ultrasonography to measure excursion, end-inspiratory and end-expiratory thickness, and thickening fraction in people with subacute hemiplegia. Respiratory muscle strength will be measured by maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Participants are adults 18–80 in the subacute phase (1–6 months post-stroke) who can tolerate ultrasound and respiratory testing and have preserved cognition. The goal is to link ultrasound-derived diaphragm morphology with objective strength measures to inform early individualized respiratory rehabilitation.
Who should consider this trial
Good fit: Adults aged 18–80 with clinical hemiplegia in the subacute phase (1–6 months), able to cooperate, with MMSE ≥ 24 and able to tolerate diaphragm ultrasound and MIP/MEP testing are ideal candidates.
Not a fit: Patients with chronic respiratory diseases, diaphragmatic paralysis, severe cognitive impairment, recent major abdominal surgery, or those outside the 1–6 month post-stroke window are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify diaphragm changes that predict respiratory weakness and guide earlier, personalized respiratory rehab after stroke.
How similar studies have performed: Prior work has shown reduced MIP/MEP after stroke and demonstrated the feasibility of diaphragm ultrasound, but direct correlations between diaphragm morphology and strength in the subacute period have been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Ataşehir
- Fenerbahçe University — Istanbul, Ataşehir, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Sümeyye Akçay, Asst. Prof. — Fenerbahçe University
- Study coordinator: Sümeyye Akçay, Asst. Prof.
- Email: smyye.akcy@gmail.com
- Phone: +905424002553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Hemiplegia Following Ischemic Stroke, Diaphragm Ultrasonography, Ischemic Stroke, Diaphragm, Ultrasonography, Pulmonary Funtion, Subacute Hemiplegia