UltrasonographyNCT06792279
Detection of Muscle Quality in Children - Protocol for a Validation Study
An observational study of Ultrasonography, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Generally healthy children
Who cannot join
- Acute illnesses
- Chronic or acute diseases of the endocrine or musculoskeletal systems
- Post-traumatic conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Faculty of Physical Education and Sport Charles University
Prague, Czech Republic, 16200
Michal Steffl, +420778701882, michal.steffl@ftvs.cuni.cz
Tereza Jandova, PhD
About this study
Official title: 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?
- Conditions
- Ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles
Echo intensity will be measured by greyscale analysis derivered from ultrasound imaging.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Skeletal Muscle Mass
Measured using DXA (Horizon DXA platform, Hologic)
Measured: Through study completion, an average of 1 year
Muscle Strength
Assessed via isokinetic and isometric knee extensor strength using a Humac Norm isokinetic dynamometer
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Šteffl, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792279
- Sponsor's protocol ID
- EK 101/2024
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jandova T, Kinkorova I, Vetrovsky T, Mala J, Musilova E, Steffl M, Narici MV. Can ultrasound echo intensity assess muscle quality in children aged 10-14 years? Protocol for a cross-sectional validation study in Czech children. BMJ Open. 2025 Sep 26;15(9):e100495. doi: 10.1136/bmjopen-2025-100495.
PubMed 41005786
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound Echo Intensity for the Detection of Muscle Quality in Children - Protocol for a Validation Study
- ClinicalTrials.gov ID
- NCT06792279
- Acronym / sponsor ID
- EK 101/2024
- Conditions
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Generally healthy children
Key exclusion criteria (3 listed)
- Acute illnesses
- Chronic or acute diseases of the endocrine or musculoskeletal systems
- Post-traumatic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Skeletal Muscle Mass
Time frame: Through study completion, an average of 1 year
Muscle Strength
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 41005786Jandova T, Kinkorova I, Vetrovsky T, Mala J, Musilova E, Steffl M, Narici MV. Can ultrasound echo intensity assess muscle quality in children aged 10-14 years? Protocol for a cross-sectional validation study in Czech children. BMJ Open. 2025 Sep 26;15(9):e100495. doi: 10.1136/bmjopen-2025-100495.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Steffl, PhD (+420778701882, michal.steffl@ftvs.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.