- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777995
A New Designed Balance Platform for Children
Reliability and Validity of a New Designed Balance Platform for Children
Study Overview
Status
Conditions
Detailed Description
Children whose families signed consent form will be included. Height and weight will be measured. Then they will be taken to the balance measurements. Design will firstly be shown to child and one trial will be permitted before starting the test. Timed-up and Go test will also be used as a reliable and valid test for dynamic balance in this age group. Single leg standing will also be used to investigate the discrimination feature of the dynamic balance tested by new design platform.
All tests will be done without socks and shoes. Timing will be the only results for all tests. Calibrated chronometers will be used for this aim. After all measurements complete, statistical analysis will be conducted.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Famagusta, Cyprus, 99628
- Zehra Güçhan Topcu
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chid aged 3-5 years (birth date: December 2013 - December 2015)
- Parents who signed consent form.
Exclusion Criteria:
- Children who have problem about musculoskeletal system, neurological disorder, vestibular system disorders.
- Children who mention painful situations which may possibly prevent to walk on the platform
- Children who have visual problems
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New designed test
Time Frame: at baseline
|
This is a walking platform which has different floor materials
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed-up and go test
Time Frame: at baseline
|
This is a reliable and valid test which is used to assess dynamic balance in children.
There is a three meter pathway.
Two chairs are used for the starting point and to specify the returning point.
The test will be repeated 3 times and the best completion time will be recorded.
|
at baseline
|
Single leg standing
Time Frame: at baseline
|
Children are asked to stand on dominant leg.
Their standing duration will be recorded.
|
at baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ZEHRA GÜÇHAN TOPCU, Eastern Mediterranean University
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
Keywords
Other Study ID Numbers
- ETK00-2018-0204
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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