Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients (UEPIMSP)

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Respiratory Muscle
• Intervention / Treatment: Diagnostic test: Parasternal intercostal muscle thickness with ultrasonography

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yunus Emre Dogan, MD; Phone Number: 05060512500; Email: ynsemredgn91@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal
    • Contact: Kadriye Ones, Prof; Phone Number: 0532 243 28 70; Email: kadriyeones@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Stroke patients and healthy volunteers (have close demographic data with stroke patients)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients; Ultrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.	Diagnostic test: Parasternal intercostal muscle thickness with ultrasonography; 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.; Other Names: Spirometry
Healthy individuals; Ultrasonographic measurements were performed of the dominant side parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.	Diagnostic test: Parasternal intercostal muscle thickness with ultrasonography; 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.; Other Names: Spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parasternal intercostal muscle thickness and thickening ratio	Parasternal intercostal muscle ultrasonographic millimetric measurement	15 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ]	15 minute

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Study Chair: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospita; Principal Investigator: Yunus Emre DOĞAN, MD, Istanbul Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Cigdem Cinar, Assoc Prof, Istanbul Biruni University; Study Chair: Burak Kutuk, MD, Hatay Defne State Hospital; Study Chair: Muhsin Doran, MD, Isttanbul Liv Hospital

Publications and helpful links

General 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.
• Yoshida 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.
• Formenti 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.
• Yoshida 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): August 28, 2024
• Study Completion (Estimated): September 4, 2024

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: stroke; ultrasound; pulmonary function test; respiratory muscle; intercostal muscle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FSMYED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No