Skip to main content
OpenTrials
Completed

NCT Number: NCT05456399

A Novel/Common Approach for Temporalis Muscle Thickness Measurement

The aim of this study is to propose a new measurement point for temporal muscle thickness (TMT) that can be similarly localized in computerized tomography (CT) /magnetic resonance imaging (MRI) and ultrasonography (USG), and to evaluate the reliability and consistency of these measurements.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcopenia Atrophy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

A Novel/Common Approach for Temporalis Muscle Thickness Measurement: Reliability and Agreement Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.