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

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT04024592
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Children; Muscle Strength; Reproducibility of Results; Muscle Strength Dynamometer; Knee	Device: Biodex System 4	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
• Actual Study Start Date: Nov 30, 2017
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: children	Device: Biodex System 4; Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.

Outcome Measures

Primary Outcome Measures

1. Isokinetic strength assessment with Biodex System 4 device [90 minutes]

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

Secondary Outcome Measures

1. Functional strength assessment [30 minutes]

   30 second tests (number of trials in 30 seconds)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy children with good intellectual capacities

Exclusion Criteria:

• children with chronic disease or intellectual deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University	Ghent		Belgium	9000

Sponsors and Collaborators

• University Ghent

Investigators

• Principal Investigator: Christine Van den Broeck, Professor, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT04024592
• Other Study ID Numbers: B670201834766
• First Posted: Jul 18, 2019
• Last Update Posted: Jul 18, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Ghent: child; dynamometry; knee joint; reproducability of results; strength testing

Study Results

No Results Posted as of Jul 18, 2019