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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03777995
Other study ID # ETK00-2018-0204
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date April 10, 2019

Study information

Verified date December 2018
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

People always come across with different floors which gradually affect dynamic balance. Dynamic balance is important in activities of daily life of all people. There are various reliable and valid tests for both children and adults, but no test design which includes different floor materials has been developed. Thus, this study aimed to describe a new designed balance test platform and investigate its reliability and validity in 3-5 years old children.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date April 10, 2019
Est. primary completion date March 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Cyprus Zehra Güçhan Topcu Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary New designed test This is a walking platform which has different floor materials at baseline
Secondary Timed-up and go test 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
Secondary Single leg standing Children are asked to stand on dominant leg. Their standing duration will be recorded. at baseline
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