- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024592
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy children with good intellectual capacities
Exclusion Criteria:
- children with chronic disease or intellectual deficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: children
|
Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic strength assessment with Biodex System 4 device
Time Frame: 90 minutes
|
Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements)
|
90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional strength assessment
Time Frame: 30 minutes
|
30 second tests (number of trials in 30 seconds)
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Van den Broeck, Professor, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B670201834766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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