Clinical trial NCT03693482: The Validity and Reliability of the Four Square Step Test
Official title: The Validity and Reliability of the Four Square Step Test in Typically Developed Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Only Child
Balance, Postural
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Typically developed children between the ages of 5-10 in Cihangir-Düzova Elementary School in Famagusta, North Cyprus.

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.

Detailed description: Participants will be assessed by two physiotherapists on two separate days. Prior to the trial, testing instructions to be delivered to participants will be translated and adapted into Turkish. In order to maximize potential agreement and to improve rating accuracy, reliability, and validity, assessment skills of the raters will be refreshed through training.

Administration of the tests will be performed in a corridor of the school. Assessments will be performed in a quiet and adequately lighted environment to minimize the distraction. Participants will be tested with their regular footwear. The demographic information of participants will be recorded. The dynamic balance performances on the four square step test (FSST) and the Timed up \& Go test (TUG) will be assessed by Rater A and B independently and these assessments repeated 24-h later. The participants will be allowed to rest up to five minutes between sessions. A stopwatch will be used to measure time to complete the FSST and TUG test.

Evaluations of concurrent and discriminative validity will be based on mean scores from the first measurement of rater A. Pearson's correlation coefficient (r) will be used to assess the concurrent validity of the FSST and TUG tests. Between-groups discriminative validity of the FSST will be evaluated by the one-way analysis of variance (ANOVA) with Bonferroni post-hoc test. Both intra- and inter-rater reliability will be assessed using intraclass correlation coefficients (ICC). ICC2,1 and ICC2,2 estimates and their 95% confidence intervals will be calculated based on absolute-agreement. Bland \& Altman plots will be constructed to demonstrate agreement between TUG and FSST, and between assessments of rater A and B.

Eligibility criteria: Inclusion Criteria:

* aged 5 to 10 years,

Exclusion Criteria:

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

Primary outcomes:
measure: The Four Square Step test
timeFrame: At baseline
Secondary outcomes:
measure: The Time Up and Go test
timeFrame: At baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: 1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
Study officials:
affiliation: Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
name: Emine H Tüzün, Prof. PhD.
role: STUDY_CHAIR
affiliation: Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
name: Levent Eker, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
name: Selma Uzuner, MSc.,PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Girne Akçiçek Hospital
name: Buse Sezerel, MSc.,PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
name: Hayriye Tomaç, MSc.,PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
name: Serpil Mıhçıoğlu, MSc.,PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Hospital Royal Talbot Rehabilitation Center, Kew, Vic, Australia
name: Wayne Dite, BAppSci (PE)
role: PRINCIPAL_INVESTIGATOR
References: