Detection of Muscle Quality in Children - Protocol for a Validation Study

Use of Ultrasound Echo Intensity for the Detection of Muscle Quality in Children - Protocol for a Validation Study

The goal of this observational study is to evaluate the validity and reliability of ultrasound echo intensity (EI) as a diagnostic tool for assessing muscle quality in children aged 10-14 years, including normal-weight, obese, and trained young athletes. The main questions it aims to answer are:

Can EI reliably and accurately measure muscle quality in children when validated against gold-standard techniques like DXA and isokinetic dynamometry? What are the age-, sex-, and fitness-specific benchmarks for EI to differentiate between normal and pathological muscle quality?

Study Overview

• Status: Not yet recruiting
• Conditions: Ultrasonography

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Michal Steffl, PhD; Phone Number: +420778701882; Email: michal.steffl@ftvs.cuni.cz

Study Locations

• Czech Republic
  • Prague, Czech Republic, 16200
    • Faculty of Physical Education and Sport Charles University
    • Contact: Michal Steffl; Phone Number: +420778701882; Email: michal.steffl@ftvs.cuni.cz
    • Contact: Tereza Jandova, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Sixty boys and sixty girls aged 10-14 years, evenly distributed as follows: normal-weight children, trained young athletes (≥3 training sessions per week), and obese children according to BMI

Description

Inclusion Criteria:

• Generally healthy children

Exclusion Criteria:

• Acute illnesses
• Chronic or acute diseases of the endocrine or musculoskeletal systems
• Post-traumatic conditions

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles	Echo intensity will be measured by greyscale analysis derivered from ultrasound imaging.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal Muscle Mass	Measured using DXA (Horizon DXA platform, Hologic)	Through study completion, an average of 1 year
Muscle Strength	Assessed via isokinetic and isometric knee extensor strength using a Humac Norm isokinetic dynamometer	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EK 101/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No