Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients

NCT ID: NCT06572709

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2024-09-04

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.

Conditions

Stroke; Respiratory Muscle

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stroke patients

Ultrasonographic measurements were performed of the bilateral parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.

Parasternal intercostal muscle thickness with ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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.

Healthy individuals

Ultrasonographic measurements were performed of the dominant side parasternal intercostal muscle thickness. Spirometry evaluation was performed by another investigator.

Parasternal intercostal muscle thickness with ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Spirometry

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunus Emre Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Fatih Sultan Mehmet Training and Research Hospital

Kadriye Ones, Prof

Role: STUDY_CHAIR

Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Cigdem Cinar, Assoc Prof

Role: STUDY_CHAIR

Istanbul Biruni University

Burak Kutuk, MD

Role: STUDY_CHAIR

Hatay Defne State Hospital

Muhsin Doran, MD

Role: STUDY_CHAIR

Isttanbul Liv Hospital

Locations

Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Yunus Emre Dogan, MD

Role: CONTACT

ynsemredgn91@gmail.com

05060512500

Facility Contacts

Kadriye Ones, Prof

Role: primary

kadriyeones@yahoo.com

0532 243 28 70

References

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.

Reference Type: BACKGROUND

PMID: 30323179 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31037006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32894372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33642691 (View on PubMed)

Other Identifiers

FSMYED

Identifier Type: -

Identifier Source: org_study_id