A New Designed Balance Platform for Children | NCT03777995

Studies
A New Designed Balance Platform for Children

NCT03777995

Sponsor

Eastern Mediterranean University

Status

Completed

Last Update Posted

Oct 24, 2019Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Child Development

Interventions

Not provided

Countries

Cyprus

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

Dec 2018

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

Dec 15, 2018Actual

Primary Completion Date

Mar 10, 2019Actual

Completion Date

Apr 10, 2019Actual

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 19, 2018Actual

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

Oct 22, 2019

Last Update Posted Date

Oct 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
New designed test	This is a walking platform which has different floor materials	at baseline

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children who have a typical development will be recruited from various kindergartens in Cyprus.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ZEHRA GÜÇHAN TOPCU	Eastern Mediterranean University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zehra Güçhan Topcu		Famagusta		99628	Cyprus