Only ChildNCT03693482
The Validity and Reliability of the Four Square Step Test
An observational study of Only Child and Balance, Postural, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Only Child, Balance, Postural
- What is being tested?
- the Four Square Step test
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Typically developed children between the ages of 5-10 in Cihangir-Düzova Elementary School in Famagusta, North Cyprus.
Who may be able to join
- aged 5 to 10 years,
Who cannot join
- have musculoskeletal or neurological disorders,
- have history of surgeries of the spine or orthopedic,
- have uncorrected visual acuity.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1. Eastern Mediterranean University Health Sciences Faculty, Department of Physiotherapy and Rehabilitation,
Ankara
About this study
Official title: The Validity and Reliability of the Four Square Step Test in Typically Developed Children
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.
Read the 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.
- Conditions
- Only Child, Balance, Postural
- Being tested
- the Four Square Step test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Four Square Step testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (1)
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start30 Oct 2018
- Primary completion15 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Only ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Handan Tüzün, Eastern Mediterranean University
- Investigators
- Emine H Tüzün, Prof. PhD., Study chair, Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,Levent Eker, Assist.Prof., Principal investigator, Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,Selma Uzuner, MSc.,PT., Principal investigator, Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,Buse Sezerel, MSc.,PT., Principal investigator, Girne Akçiçek HospitalHayriye Tomaç, MSc.,PT., Principal investigator, Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,Serpil Mıhçıoğlu, MSc.,PT., Principal investigator, Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,Wayne Dite, BAppSci (PE), Principal investigator, Austin Hospital Royal Talbot Rehabilitation Center, Kew, Vic, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693482
- Sponsor's protocol ID
- ETK00-2018-0202
- Status last verified
- Sep 2019
- First submitted
- 1 Oct 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Four Square Step Test in Typically Developed Children
- ClinicalTrials.gov ID
- NCT03693482
- Acronym / sponsor ID
- ETK00-2018-0202
- Conditions
- Only Child, Balance, Postural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Typically developed children between the ages of 5-10 in Cihangir-Düzova Elementary School in Famagusta, North Cyprus.
Key inclusion criteria (1 listed)
- aged 5 to 10 years,
Key exclusion criteria (3 listed)
- have musculoskeletal or neurological disorders,
- have history of surgeries of the spine or orthopedic,
- have uncorrected visual acuity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Four Square Step testA 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. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
The Time Up and Go test
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine H Tüzün, Prof. PhD. study chair
Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
Levent Eker, Assist.Prof. principal investigator
Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
Selma Uzuner, MSc.,PT. principal investigator
Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Only Child and Balance, Postural, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Four Square Step test (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019; AzTrials last refreshed its copy on 2 Nov 2026.