Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients

Recruiting

• Conditions: Stroke; Respiratory Muscle
• Interventions: Diagnostic Test: Parasternal intercostal muscle thickness with ultrasonography

• Registration Number: NCT06572709
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Brief Summary

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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-07
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-08-28
• Study Completion: 2024-09-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Ischemic or Hemorrhagic stroke patients, Stroke duration >6 months, Mini-mental test score >24

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients	Parasternal intercostal muscle thickness with ultrasonography	Ultrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.
Healthy individuals	Parasternal intercostal muscle thickness with ultrasonography	Ultrasonographic measurements were performed of the dominant side parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.

Primary Outcome Measures

Name	Time	Method
Parasternal intercostal muscle thickness and thickening ratio	15 minute	Parasternal intercostal muscle ultrasonographic millimetric measurement

Secondary Outcome Measures

Name	Time	Method
Correlation between parasternal intercostal muscle thicknesses and spirometry parameters	15 minute	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 \]

Trial Locations

Locations (1)

Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal; 🇹🇷 Istanbul, Turkey