Reliability and Validity of Strength Measurement of the L... | NCT04024592

Studies
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children

NCT04024592

Sponsor

University Ghent

Status

Completed

Last Update Posted

Jul 18, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Children
Muscle Strength
Reproducibility of Results
Muscle Strength Dynamometer
Knee

Interventions

Biodex System 4

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2017Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Apr 30, 2018Actual

First Submitted Date

Jan 24, 2019

First Submission Date that Met QC Criteria

Jul 17, 2019

First Posted Date

Jul 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2019

Last Update Posted Date

Jul 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.

Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children	Experimental		Device: Biodex System 4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biodex System 4	Device	Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.	children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Functional strength assessment	30 second tests (number of trials in 30 seconds)	30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy children with good intellectual capacities

Exclusion Criteria:

children with chronic disease or intellectual deficiency

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine Van den Broeck, Professor	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided