NCT03693482

Brief Summary

This study will evaluate concurrent and discriminative validity, reliability and level of agreement between the Timed Up \& Go test and the four square step test in typically developed children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

October 1, 2018

Last Update Submit

September 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Four Square Step test

    Assessing of the dynamic balance in typically developed children. A square will be formed by using four 90 cm long canes placed on the ground. Instructions will be given and encouraged to complete the sequence as fast as possible without touching the canes. The sequence of trial was 1,2,3,4,1,4,3,2,1. The best time will be taken as the score of FSST which are completed successfully.

    At baseline

Secondary Outcomes (1)

  • The Time Up and Go test

    At baseline

Interventions

A square will be formed by using four 90 cm long canes placed on the ground. The sequence will be explained and demonstrated to the participants. They will be allowed one practice trial and subsequently two trials. Instructions will be given and encouraged to complete the sequence as fast as possible without touching the canes. The sequence of trial was 1,2,3,4,1,4,3,2,1. If a participant touch the canes, or perform the test sequence inaccurately, or both feet of the participant do not make contact with the floor in each square, the trial will be considered as unsuccessful and the test will be repeated. One unsuccessful trial will be allowed. The best time will be taken as the score of FSST which are completed successfully.

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Typically developed children between the ages of 5-10 in Cihangir-Düzova Elementary School in Famagusta, North Cyprus.

You may qualify if:

  • aged 5 to 10 years,

You may not qualify if:

  • have musculoskeletal or neurological disorders,
  • have history of surgeries of the spine or orthopedic,
  • have uncorrected visual acuity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Emine H Tüzün, Prof. PhD.

    Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,

    STUDY CHAIR
  • Levent Eker, Assist.Prof.

    Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,

    PRINCIPAL INVESTIGATOR
  • Selma Uzuner, MSc.,PT.

    Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,

    PRINCIPAL INVESTIGATOR
  • Buse Sezerel, MSc.,PT.

    Girne Akçiçek Hospital

    PRINCIPAL INVESTIGATOR
  • Hayriye Tomaç, MSc.,PT.

    Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,

    PRINCIPAL INVESTIGATOR
  • Serpil Mıhçıoğlu, MSc.,PT.

    Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,

    PRINCIPAL INVESTIGATOR
  • Wayne Dite, BAppSci (PE)

    Austin Hospital Royal Talbot Rehabilitation Center, Kew, Vic, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

October 30, 2018

Primary Completion

June 15, 2019

Study Completion

July 30, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations