NCT06572709

Brief Summary

Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

21 days

First QC Date

August 23, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

strokeintercostal musclepulmonary function testrespiratory muscleultrasound

Outcome Measures

Primary Outcomes (1)

  • Parasternal intercostal muscle thickness and thickening ratio

    Parasternal intercostal muscle ultrasonographic millimetric measurement

    15 minute

Secondary Outcomes (1)

  • Correlation between parasternal intercostal muscle thicknesses and spirometry parameters

    15 minute

Study Arms (2)

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

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

Interventions

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.

Also known as: Spirometry
Healthy individualsStroke patients

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30323179BACKGROUND
  • 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.

    PMID: 31037006BACKGROUND
  • 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.

    PMID: 32894372BACKGROUND
  • 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.

    PMID: 33642691BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

UltrasonographySpirometry

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory System

Study Officials

  • Yunus Emre Dogan, MD

    Istanbul Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Kadriye Ones, Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospita

    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

    STUDY CHAIR

Central Study Contacts

Yunus Emre Dogan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

August 7, 2024

Primary Completion

August 28, 2024

Study Completion

September 4, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations