Force MeasurementNCT06667492
Lower Extremity Dynamometry Assessment in Neurotypical Children
An observational study of Force Measurement and Children, run by University of Thessaly at 1 site in Greece.
Trial summary
The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Force Measurement, Children, Lower Limb
- What is being tested?
- Traction Dynamometry
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 20 Sep 2024to Sep 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of typically developing children aged 5 to 16 years, selected based on specific inclusion and exclusion criteria to ensure the reliability and validity of traction dynamometry.
Who may be able to join
- typically developing children,
- between the ages of 5 and 16 years,
- have the capacity for voluntary motor control
Who cannot join
- undergone any treatment or intervention that could impact neuromuscular performance, such as surgery or medication use,
- experienced a recent injury
- demonstrating low levels of compliance during assessments are not included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Physiotherapy - University of Thessaly
Lamia, Phthiotis, 35132
George Paras, Ph.D., 2231060234 ext. +30, gparas@uth.gr
About this study
Official title: Reliability and Validity of Lower Extremity Dynamometry Assessment in Neurotypical Children
The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.
- Conditions
- Force Measurement, Children, Lower Limb, Assessment Tool
- Being tested
- Traction Dynamometry
- Keywords
- dynamometry, lower limb, assessment, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction DynamometryDevice
K-Pull dynamometer (Model MP.09.02.FN, Kinvent, Montpellier, France) is an assessment tool used to quantify muscle strength. It uses traction through a non-elastic strap to facilitate isometric contractions. This instrument will be used to evaluate isometric activity (maximum and average torque values) of the hip and knee flexors and extensors at specific joint angles.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-typical Children | Typically developing children aged 5 to 16 years with the ability of voluntary motor control are in included in the study. Receives: Device: Traction Dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Peak Torque
Average Peak Torque refers to the average highest force output recorded during isometric contractions and represents the maximal strength generated by the muscle group being assessed (e.g., hip or knee flexors and extensors). Unit of Measure: Newton-metre (Nm)
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start20 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Force MeasurementStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Paras, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667492
- Sponsor's protocol ID
- dynam-neurotyp-child
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.
PubMed 26397089Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.
PubMed 29802034
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Lower Extremity Dynamometry Assessment in Neurotypical Children
- ClinicalTrials.gov ID
- NCT06667492
- Acronym / sponsor ID
- dynam-neurotyp-child
- Conditions
- Force Measurement, Children, Lower Limb, Assessment Tool
- Keywords
- dynamometry, lower limb, assessment, child
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 31 Oct 2024 (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 purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-typical Children | – | Device: Traction DynamometryTypically developing children aged 5 to 16 years with the ability of voluntary motor control are in included in the study. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of typically developing children aged 5 to 16 years, selected based on specific inclusion and exclusion criteria to ensure the reliability and validity of traction dynamometry.
Key inclusion criteria (3 listed)
- typically developing children,
- between the ages of 5 and 16 years,
- have the capacity for voluntary motor control
Key exclusion criteria (3 listed)
- undergone any treatment or intervention that could impact neuromuscular performance, such as surgery or medication use,
- experienced a recent injury
- demonstrating low levels of compliance during assessments are not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traction DynamometryK-Pull dynamometer (Model MP.09.02.FN, Kinvent, Montpellier, France) is an assessment tool used to quantify muscle strength. It uses traction through a non-elastic strap to facilitate isometric contractions. This instrument will be used to evaluate isometric activity (maximum and average torque values) of the hip and knee flexors and extensors at specific joint angles. | Device | Neuro-typical Children |
Primary outcome
Average Peak Torque
Time frame: Through study completion, an average of 5 months
Average Peak Torque refers to the average highest force output recorded during isometric contractions and represents the maximal strength generated by the muscle group being assessed (e.g., hip or knee flexors and extensors). Unit of Measure: Newton-metre (Nm)
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 29 Dec 2025.
- Background: PubMed 26397089Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.
- Background: PubMed 29802034Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.
- 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 Force Measurement and Children, run by University of Thessaly at 1 site in Greece.
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 3 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: looking for participants now, as of the sponsor's last update on 29 Dec 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 Greece. 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 George Paras, Ph.D. (2231060234 ext. +30, gparas@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Peak Torque (time frame: Through study completion, an average of 5 months). 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 NCT06667492, which also lists 2 linked publications.
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 29 Dec 2025.