Clinical Trial on Stroke, Sarcopenia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

Recently, temporal muscle thickness (TMT) has been proposed as a new marker of whole-body muscle function. In addition, TMT has been shown to be a useful parameter for estimating skeletal muscle mass. Measurement of temporal muscle mass with CT and MRI has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. However, the literature indicates that USG can also be used to measure temporal muscle thickness. The recommended measurement points for CT, MRI, or USG in the studies performed to date depend on the particular imaging modality, and it does not seem possible to use them interchangeably. The aim of this study is to propose a new TMT measurement point that can be localized in a similar way in CT /MRI and USG, and to evaluate the reliability and agreement of these measurements.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - İzmir, Turkey
    - Izmir Bozyaka Research and Training Hostpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A tertiary health care facility

Description

Inclusion Criteria:

Referral to the radiology department for an MRI or CT scan

Exclusion Criteria:

Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
Vulnerable populations (patients with a terminal illness, people living in nursing homes, unemployed or poor people, people in need of urgent medical care, children, people unable to consent, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with cranial MRI Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography.
Patients with cranial CT Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography.

Group / Cohort

Patients with cranial MRI

Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography.

Patients with cranial CT

Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-rater reliability of ultrasonographic TMT measurement. Time Frame: Baseline	The intraclass correlation coefficient (ICC) of the two measurements performed by the physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement" model.	Baseline
Inter-rater reliability of ultrasonographic TMT measurement. Time Frame: Baseline	Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, multiple raters/measurements " model.	Baseline
Inter-rater reliability of TMT measurements of MRI and CT Time Frame: Baseline	Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement " model.	Baseline
Agreement of ultrasonographic TMT measurement with MRI and CT measurements. Time Frame: Baseline	The intraclass correlation coefficient of the measurements will be calculated using the "two-way mixed effects, absolute agreement, multiple raters/measurements" model. In addition, the agreement of the measurements will be evaluated using the Bland-Altman method. Furthermore, the Technical Error of Measurement (TEM) will be calculated.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

Principal Investigator: Bugra Ince, MD, Izmir Bozyaka Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2022

Primary Completion (Actual)

February 18, 2023

Study Completion (Actual)

February 18, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified