NCT06667492

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2024Sep 2026

Study Start

First participant enrolled

September 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

October 27, 2024

Last Update Submit

December 19, 2025

Conditions

Keywords

dynamometrylower limbassessmentchild

Outcome Measures

Primary Outcomes (1)

  • 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)

    Through study completion, an average of 5 months

Study Arms (1)

Neuro-typical Children

Typically developing children aged 5 to 16 years with the ability of voluntary motor control are in included in the study.

Device: Traction Dynamometry

Interventions

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.

Neuro-typical Children

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • typically developing children,
  • between the ages of 5 and 16 years,
  • have the capacity for voluntary motor control

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, 35132, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26397089BACKGROUND
  • 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.

    PMID: 29802034BACKGROUND

Central Study Contacts

George Paras, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 31, 2024

Study Start

September 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations