A New Method for Measuring Temporal Muscle Thickness: Reliability and Agreement Study.

Sponsor
Bozyaka Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05456399
Collaborator
(none)
60
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A New Method for Measuring Temporal Muscle Thickness: Reliability and Agreement Study.
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with cranial MRI

    Axial sections of 5 mm and 1 mm thickness will be imaged. The thickness of the temporal muscle will be measured from the posterior angle, where the temporal fossa loses its cavity. 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 and 1 mm thickness will be imaged. The thickness of the temporal muscle will be measured from the posterior angle, where the temporal fossa loses its cavity. 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.

    Outcome Measures

    Primary Outcome Measures

    1. Intra-rater reliability of ultrasonographic TMT measurement. [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. [Baseline]

      Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way random effects, absolute agreement, multiple raters/measurements ICC (2,k)" model.

    3. Inter-rater reliability of TMT measurements of MRI [Baseline]

      Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way random effects, absolute agreement, single rater/measurement ICC (2.1)" model.

    4. Agreement of ultrasonographic TMT measurement with MRI and CT measurements. [Baseline]

      The intraclass correlation coefficient of the measurements will be calculated using the "two-way random effects, absolute agreement, multiple raters/measurements ICC (2,k)" 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bozyaka Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bozyaka Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05456399
    Other Study ID Numbers:
    • BITMA072022
    First Posted:
    Jul 13, 2022
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 13, 2022