NCT03777995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

October 24, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 14, 2018

Last Update Submit

October 22, 2019

Conditions

Child Development

Keywords

Balance

Outcome Measures

Primary Outcomes (1)

  • New designed test

    This is a walking platform which has different floor materials

    at baseline

Secondary Outcomes (2)

  • Timed-up and go test

    at baseline

  • Single leg standing

    at baseline

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Chid aged 3-5 years (birth date: December 2013 - December 2015)
  • Parents who signed consent form.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zehra Güçhan Topcu

Famagusta, 99628, Cyprus

Location

Study Officials

  • ZEHRA GÜÇHAN TOPCU

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

December 15, 2018

Primary Completion

March 10, 2019

Study Completion

April 10, 2019

Last Updated

October 24, 2019

Record last verified: 2018-12

Locations

CY(1)