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NCT Number: NCT06792279

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?

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Key information

Conditions

Ultrasonography

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Physical Education and Sport Charles University

Prague, Czech Republic, 16200, Czechia

Location contact

Michal Steffl

CONTACT

[email protected]

+420778701882

Tereza Jandova, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally healthy children

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles

    Time frame: Through study completion, an average of 1 year

    Echo intensity will be measured by greyscale analysis derivered from ultrasound imaging.

Secondary outcomes

  1. Skeletal Muscle Mass

    Time frame: Through study completion, an average of 1 year

    Measured using DXA (Horizon DXA platform, Hologic)

  2. Muscle Strength

    Time frame: Through study completion, an average of 1 year

    Assessed via isokinetic and isometric knee extensor strength using a Humac Norm isokinetic dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Steffl, PhD

CONTACT

[email protected]

+420778701882

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

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.

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