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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03693482
Other study ID # ETK00-2018-0202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2018
Est. completion date July 30, 2019

Study information

Verified date September 2019
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 30, 2019
Est. primary completion date June 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
the Four Square Step test
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.

Locations

Country Name City State
Turkey 1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation, Ankara

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The Time Up and Go test Assessing of the dynamic balance in typically developed children. A three meter pathway on the testing floor will be marked with red colored masking tape. The TUG will be administered using 2 standard chairs. The best time will be taken as the score of TUG which are completed successfully. At baseline
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