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

Not yet recruiting

• Conditions: Ultrasonography

• Registration Number: NCT06792279
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-03-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Generally healthy children

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Physical Education and Sport Charles University; 🇨🇿 Prague, Czech Republic