- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693482
The Validity and Reliability of the Four Square Step Test
The Validity and Reliability of the Four Square Step Test in Typically Developed Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- 1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Four Square Step test
Time Frame: At baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Time Up and Go test
Time Frame: At baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Emine H Tüzün, Prof. PhD., Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ETK00-2018-0202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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