StrokeUEPIMSPNCT06572709
Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients
An observational study of Stroke and Respiratory Muscle, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Respiratory Muscle
- What is being tested?
- Parasternal intercostal muscle thickness with ultrasonography
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2024to 4 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients and healthy volunteers (have close demographic data with stroke patients)
Who may be able to join
- Ischemic or Hemorrhagic stroke patients, Stroke duration >6 months, Mini-mental test score >24
Who cannot join
- Individuals with acute or chronic lung disease, Patients with a history of thoracic or abdominal surgery, Patients with other neuromuscular diseases, Aphasia type with impaired understanding, Facial paralysis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal
Istanbul
Kadriye Ones, Prof, 0532 243 28 70, kadriyeones@yahoo.com
About this study
Official title: Ultrasonographic Evaluation of Parasternal Intercostal Muscles and Their Correlation With Respiratory Function Test in Stroke Patients
Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients
Read the detailed description
The clinical study, planned as a cross-sectional prospective, will be conducted on 30 stroke patients followed in the same stroke clinic and a total of 30 healthy volunteers of similar age and gender to the stroke patients. Patients with ischemic or hemorrhagic stroke with stroke duration >6 months and mini-mental test score >24 will be included in the study; Stroke patients with acute or chronic lung disease, a history of thoracic surgery, another neuromuscular disease, aphasia type in which comprehension is impaired, and facial paralysis will not be included in the study. Written informed consent will be obtained from those who meet the study criteria and agree to participate in the study.
Demographic data of patients and healthy volunteers (gender, age, height, weight, body mass index, dominant extremity, stroke etiology, duration, side), respiratory function test (PFT) parameters measurement results, bilateral parasternal intercostal muscle thickness in stroke patients and the dominant side parasternal intercostal muscle thicknesses in healthy volunteers will be measured with Ultrasound (US), thickening rates will be calculated and recorded.
All participants will be evaluated in B-mode using the MyLab60 brand US device with 7-12 MHz linear probe. Measurements will be taken at the end of tidal expiration and maximal inspiration while the participants are in the supine position. To evaluate intercostal muscle thickness, measurements will be made between the 2nd and 3rd ribs, 3 cm lateral to the sternum, in accordance with the literature. The probe will be placed vertically at this point in the sagittal plane, a vertical caliper will be drawn between the hyperechoic fascia lines on the pleura and this distance will be recorded in millimeters. All measurements will be repeated 3 times, the average value will be recorded and thickening rates will be calculated. The formula [(end-inspiratory thickness - end-expiratory thickness) / end-expiratory thickness] will be used to calculate the thickening ratio. US evaluation of each participant will be performed by an experienced physician with more than 5 years of experience in this field.
Respiratory functions of the individuals included in the study will be measured with a CHEST HI-105 10510759 model spirometer, according to the American Thoracic Society and European Respiratory Society criteria. Forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], FEV1/FVC, maximal expiratory flow rate [PEF] values and their percentage predictive values will be recorded. MicroRPM Respiratory Meter device (MicroDirect, USA) will be used for respiratory muscle strength measurements (maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP]). PFT of all participants will be performed by a different researcher who is blind to the US measurement results.
- Conditions
- Stroke, Respiratory Muscle
- Being tested
- Parasternal intercostal muscle thickness with ultrasonography
- Keywords
- stroke, intercostal muscle, pulmonary function test, respiratory muscle, ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal intercostal muscle thickness with ultrasonographyDiagnostic test
Also called Spirometry
Ultrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness in the supine position in the stroke patient group. Ultrasonographic measurements were performed of dominant side parasternal intercostal muscle thickness in the supine position in healthy individuals group. Spirometry evaluation was performed in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Ultrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator. Receives: Diagnostic Test: Parasternal intercostal muscle thickness with ultrasonography | |
| Healthy individuals | Ultrasonographic measurements were performed of the dominant side parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator. Receives: Diagnostic Test: Parasternal intercostal muscle thickness with ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasternal intercostal muscle thickness and thickening ratio
Parasternal intercostal muscle ultrasonographic millimetric measurement
Measured: 15 minute
Secondary outcomes (1)
Correlation between parasternal intercostal muscle thicknesses and spirometry parameters
Vital capacity[VC], forced vital capacity [FVC], forced expiratory volume 1 second [FEV1] , FEV1/FVC, maximal expiratory flow rate [PEF], maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP] in patients' PFT ]
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start7 Aug 2024
- Primary completion28 Aug 2024 (estimated)
- Study completion4 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunus Emre Dogan, MD, Principal investigator, Istanbul Fatih Sultan Mehmet Training and Research HospitalKadriye Ones, Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research HospitaCigdem Cinar, Assoc Prof, Study chair, Istanbul Biruni UniversityBurak Kutuk, MD, Study chair, Hatay Defne State HospitalMuhsin Doran, MD, Study chair, Isttanbul Liv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572709
- Sponsor's protocol ID
- FSMYED
- Acronym
- UEPIMSP
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallbridge P, Parry SM, Das S, Law C, Hammerschlag G, Irving L, Hew M, Steinfort D. Parasternal intercostal muscle ultrasound in chronic obstructive pulmonary disease correlates with spirometric severity. Sci Rep. 2018 Oct 15;8(1):15274. doi: 10.1038/s41598-018-33666-7.
PubMed 30323179Yoshida R, Tomita K, Kawamura K, Nozaki T, Setaka Y, Monma M, Ohse H. Measurement of intercostal muscle thickness with ultrasound imaging during maximal breathing. J Phys Ther Sci. 2019 Apr;31(4):340-343. doi: 10.1589/jpts.31.340. Epub 2019 Apr 1.
PubMed 31037006Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.
PubMed 32894372Yoshida R, Tomita K, Kawamura K, Setaka Y, Ishii N, Monma M, Mutsuzaki H, Mizukami M, Ohse H, Imura S. Investigation of inspiratory intercostal muscle activity in patients with spinal cord injury: a pilot study using electromyography, ultrasonography, and respiratory inductance plethysmography. J Phys Ther Sci. 2021 Feb;33(2):153-157. doi: 10.1589/jpts.33.153. Epub 2021 Feb 13.
PubMed 33642691
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Parasternal Intercostal Muscles and Their Correlation With Respiratory Function Test in Stroke Patients
- ClinicalTrials.gov ID
- NCT06572709
- Acronym / sponsor ID
- UEPIMSP / FSMYED
- Conditions
- Stroke, Respiratory Muscle
- Keywords
- stroke, intercostal muscle, pulmonary function test, respiratory muscle, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 28 Aug 2024 (estimated)
- Study completion
- 4 Sep 2024 (estimated)
- First posted
- 27 Aug 2024 (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.
Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients
Detailed description
The clinical study, planned as a cross-sectional prospective, will be conducted on 30 stroke patients followed in the same stroke clinic and a total of 30 healthy volunteers of similar age and gender to the stroke patients. Patients with ischemic or hemorrhagic stroke with stroke duration >6 months and mini-mental test score >24 will be included in the study; Stroke patients with acute or chronic lung disease, a history of thoracic surgery, another neuromuscular disease, aphasia type in which comprehension is impaired, and facial paralysis will not be included in the study. Written informed consent will be obtained from those who meet the study criteria and agree to participate in the study.
Demographic data of patients and healthy volunteers (gender, age, height, weight, body mass index, dominant extremity, stroke etiology, duration, side), respiratory function test (PFT) parameters measurement results, bilateral parasternal intercostal muscle thickness in stroke patients and the dominant side parasternal intercostal muscle thicknesses in healthy volunteers will be measured with Ultrasound (US), thickening rates will be calculated and recorded.
All participants will be evaluated in B-mode using the MyLab60 brand US device with 7-12 MHz linear probe. Measurements will be taken at the end of tidal expiration and maximal inspiration while the participants are in the supine position. To evaluate intercostal muscle thickness, measurements will be made between the 2nd and 3rd ribs, 3 cm lateral to the sternum, in accordance with the literature. The probe will be placed vertically at this point in the sagittal plane, a vertical caliper will be drawn between the hyperechoic fascia lines on the pleura and this distance will be recorded in millimeters. All measurements will be repeated 3 times, the average value will be recorded and thickening rates will be calculated. The formula [(end-inspiratory thickness - end-expiratory thickness) / end-expiratory thickness] will be used to calculate the thickening ratio. US evaluation of each participant will be performed by an experienced physician with more than 5 years of experience in this field.
Respiratory functions of the individuals included in the study will be measured with a CHEST HI-105 10510759 model spirometer, according to the American Thoracic Society and European Respiratory Society criteria. Forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], FEV1/FVC, maximal expiratory flow rate [PEF] values and their percentage predictive values will be recorded. MicroRPM Respiratory Meter device (MicroDirect, USA) will be used for respiratory muscle strength measurements (maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP]). PFT of all participants will be performed by a different researcher who is blind to the US measurement results.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Diagnostic Test: Parasternal intercostal muscle thickness with ultrasonographyUltrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator. |
| Healthy individuals | – | Diagnostic Test: Parasternal intercostal muscle thickness with ultrasonographyUltrasonographic measurements were performed of the dominant side parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients and healthy volunteers (have close demographic data with stroke patients)
Key inclusion criteria (1 listed)
- Ischemic or Hemorrhagic stroke patients, Stroke duration >6 months, Mini-mental test score >24
Key exclusion criteria (1 listed)
- Individuals with acute or chronic lung disease, Patients with a history of thoracic or abdominal surgery, Patients with other neuromuscular diseases, Aphasia type with impaired understanding, Facial paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal intercostal muscle thickness with ultrasonographyAlso: SpirometryUltrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness in the supine position in the stroke patient group. Ultrasonographic measurements were performed of dominant side parasternal intercostal muscle thickness in the supine position in healthy individuals group. Spirometry evaluation was performed in both groups. | Diagnostic test | Healthy individuals, Stroke patients |
Primary outcome
Parasternal intercostal muscle thickness and thickening ratio
Time frame: 15 minute
Parasternal intercostal muscle ultrasonographic millimetric measurement
1 secondary outcome
Correlation between parasternal intercostal muscle thicknesses and spirometry parameters
Time frame: 15 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 30323179Wallbridge P, Parry SM, Das S, Law C, Hammerschlag G, Irving L, Hew M, Steinfort D. Parasternal intercostal muscle ultrasound in chronic obstructive pulmonary disease correlates with spirometric severity. Sci Rep. 2018 Oct 15;8(1):15274. doi: 10.1038/s41598-018-33666-7.
- Background: PubMed 31037006Yoshida R, Tomita K, Kawamura K, Nozaki T, Setaka Y, Monma M, Ohse H. Measurement of intercostal muscle thickness with ultrasound imaging during maximal breathing. J Phys Ther Sci. 2019 Apr;31(4):340-343. doi: 10.1589/jpts.31.340. Epub 2019 Apr 1.
- Background: PubMed 32894372Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.
- Background: PubMed 33642691Yoshida R, Tomita K, Kawamura K, Setaka Y, Ishii N, Monma M, Mutsuzaki H, Mizukami M, Ohse H, Imura S. Investigation of inspiratory intercostal muscle activity in patients with spinal cord injury: a pilot study using electromyography, ultrasonography, and respiratory inductance plethysmography. J Phys Ther Sci. 2021 Feb;33(2):153-157. doi: 10.1589/jpts.33.153. Epub 2021 Feb 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yunus Emre Dogan, MD principal investigator
Istanbul Fatih Sultan Mehmet Training and Research Hospital
Kadriye Ones, Prof study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Cigdem Cinar, Assoc Prof study chair
Istanbul Biruni 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 Respiratory Muscle, run by Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunus Emre Dogan, MD (05060512500, ynsemredgn91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasternal intercostal muscle thickness and thickening ratio (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572709, which also lists 4 linked publications.
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 27 Aug 2024.