- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667492
Lower Extremity Dynamometry Assessment in Neurotypical Children
December 19, 2025 updated by: George Paras, University of Thessaly
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Paras, Ph.D.
- Phone Number: +30 2231060234
- Email: gparas@uth.gr
Study Locations
-
-
Phthiotis
-
Lamia, Phthiotis, Greece, 35132
- Recruiting
- Department of Physiotherapy - University of Thessaly
-
Contact:
- George Paras, Ph.D.
- Phone Number: +30 2231060234
- Email: gparas@uth.gr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- typically developing children,
- between the ages of 5 and 16 years,
- have the capacity for voluntary motor control
Exclusion Criteria :
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Neuro-typical Children
Typically developing children aged 5 to 16 years with the ability of voluntary motor control are in included in the study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Through study completion, an average of 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Daloia 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
October 27, 2024
First Submitted That Met QC Criteria
October 29, 2024
First Posted (Actual)
October 31, 2024
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- dynam-neurotyp-child
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.