NCT04024592

Brief Summary

Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

January 24, 2019

Last Update Submit

July 17, 2019

Conditions

ChildrenMuscle StrengthReproducibility of ResultsMuscle Strength DynamometerKnee

Keywords

childdynamometryknee jointreproducability of resultsstrength testing

Outcome Measures

Primary Outcomes (1)

  • Isokinetic strength assessment with Biodex System 4 device

    Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements)

    90 minutes

Secondary Outcomes (1)

  • Functional strength assessment

    30 minutes

Study Arms (1)

children

EXPERIMENTAL
Device: Biodex System 4

Interventions

Biodex System 4DEVICE

Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.

children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy children with good intellectual capacities

You may not qualify if:

  • children with chronic disease or intellectual deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Study Officials

  • Christine Van den Broeck, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2019

First Posted

July 18, 2019

Study Start

November 30, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

BE(1)