AgingNCT03785639
Factors Contributing to Single and Dual Task Performance of Four Square Step Tests
An observational study of Aging, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
There are many tests that evaluate fall and balance. As a clinical test, the Four Square Step Test (FSST)Test is reliable, valid, easy to score, quick to administer, requires little space, and needs no special equipment. It is unique in that it involves stepping over low objects (2.5cm) and movement in 4 directions. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2018to 31 Aug 2020
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty healthy active (joining social activities, sports and artistic activities etc.) participants (men and women) between the ages of 50-65 will be included in the study.
Who may be able to join
- At least to graduate from primary school or ability to read and write
- Mini mental test score> 24
- Functional reach test score≥15 cm
- Ability to walking independently in the community
Who cannot join
- Living in nursing home
- Presence of central nervous system disease (dementia, Parkinson's disease, stroke, etc.)
- Polypharmacy (more than 6 medications per day)
- Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.
- Presence of musculoskeletal injuries or impairments (NEH limitation, muscle weakness, etc.), which may affect the performance in physical tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Contributing to Single and Dual Task Performance of Four Square Step Tests in the Healthy Middle Age Group
There are many tests that evaluate fall and balance. As a clinical test, the Four Square Step Test (FSST)Test is reliable, valid, easy to score, quick to administer, requires little space, and needs no special equipment. It is unique in that it involves stepping over low objects (2.5cm) and movement in 4 directions. FSST was developed in 2002 to measure the rapid stepping that is often required when changing direction and avoiding obstacles while walking. The FSST requires a stopwatch and four single point sticks. Using the sticks resting flat on the floor to form a cross, the subject starts in one square and steps in one direction into each of the four squares and then reverses direction back to the start. The FSST is unique in that it challenges motor planning, sequencing and recall, whilst simultaneously providing clinicians with the opportunity to measure and observe a person's clearance of low obstacles at speed. The ability to clear the trail leg when stepping over an obstacle has been shown to be reduced in healthy populations. Dual task is simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. Individuals have difficulties in performing two tasks together. When two tasks are performed at the same time, deterioration in performance of one or both is called dual task interference. This occurs when task requirements exceed the capacity. Age, walking speed, lower extremity muscle strength and cognitive status are factors that contribute to the dual task. In addition, prioritizing the motor or cognitive task in a dual task affects the dual task performance. Knowing these factors and improving some of them can help to create training programs designed to improve the dual task performance of individuals. There are several studies investigating factors contributing to dual task performance that focus on balance in the elderly. However, the studies including middle age group are limited. There are no studies evaluating the factors contributing to the single and dual task performance of FSST in the literature. In this study, it is aimed to explain the factors related to motor and cognitive functions to the single and dual task performance of FSST.
Read the detailed description
Participants: Healthy middle age group (50-65 years) Method: Demographic information of all participants (age, gender, body mass index), educational level (primary, undergraduate, graduate), history of falling (at least in 6 months), comorbidities (hypertension, diabetes, kidney diseases, etc.), drug using (how many per day, which one) to be examined by questionnaire and also visual impairment, the use of glasses will be recorded. Motor skills of participants; muscle strength, range of motion (ROM), gait speed (14m), Functional Reach Test will be evaluated. The Mini Mental Test and the Stroop test will be used to evaluate cognitive skills. Single and dual task performance will be evaluated by FSST.
The participants performed the FSST;
- FSST single: This test is consist of only FSST.
- FSST motor: FSST is combined with a motor task (carrying a cup of water)
- FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As prioritization affects dual task performance, in this study the prioritization will be used in dual task's evaluation. Therefore the dual task will be perform as;
1-With no prioritization 2-With prioritization (focus on balance task) 3-With prioritization (focus on cognitive task) 4-With prioritization (focus on motor task) Note: Balance task is FSST. Cognitive task is auditory N-back test. Motor task is carrying a cup of water.
Statistical Analyses:
The data will be analyzed with Statistical Package for the Social Sciences (SPSS) 21.0 package program. Descriptive statistical information will be given as mean (X) ± standard deviation (X ± SD) and minimum (min), maximum (max) frequency (f) and percentage (%). The variables will be tested for normality using the Kolmogorov-Smirnov test. When the parametrical test assumptions are obtained, the correlation between the FSST single, FSST motor and FSST cognitive is evaluated by Pearson Correlation Analysis, if the parametrical test assumptions are not obtained, Spearman Correlation Analysis will be used. Multiple linear regression analysis will be applied to determine which potential factor is effective in performance in each FSST test. As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 85% power could be obtained at 95% confidence level when at least 60 people.
- Conditions
- Aging
- Keywords
- balance, dual task, Four Square Step Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Grip strength and muscle strength of low extremities will be evaluated with using hand-held dynamometer. The measured value will be recorded in newton.
Measured: 20 minutes
Range of motion
Range of motions of hip, knee and ankle will be assessed by goniometer.
Measured: 10 minutes
Gait speed
Gait speed will be evaluated on a flat surface and at a distance of 14 meters. The walking speed will be recorded in m/sec.
Measured: 2 minutes
Functional ReachTest
The FRT assesses limits of stability by measuring the maximum distance that an individual can reach forward while standing in a fixed position. A 122 cm ruler will be fastened to the wall with tape at the height of the subject's acromion process. The subject will be instructed to make a fist and raise the arm to 90 degrees of shoulder flexion. An initial measurement will be record at the position of the subject's third metacarpal. The subject will be instructed to reach as far forward as possible while keeping the fist parallel and level with the ruler and without taking a step or touching the wall.
Measured: 2 minutes
Stroop Test
This test evaluate cognitive abilities. the Stroop Test is a useful measuring tool for especially the fields of psychiatry, neurology, neurosurgery, and clinical psychology and for the basic science field of experimental psychology. The test is used to evaluate cognitive processes such as frontal lobe functions and attention, information processing periods.
Measured: 10 minutes
Four Square Step Test (FSST)
FSST is designed for assessing balance. The participants will be asked to stand in square number 1 facing square number 2 and to step clockwise forward, then right, backward and left, then anticlockwise right, forward and left and finally backward. The stopwatch will start when the first foot contacted the floor in square 2 and will finish when the last foot came back to touch the floor in square 1. Single and dual task performance will be evaluated by FSST.
The participants performed the FSST; FSST single: This test is consist of only FSST. FSST motor: FSST is combined with a motor task (carrying a cup of water) FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As prioritization affects dual task performance, in this study the prioritization will be used in dual task's evaluation.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start14 Dec 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suat EREL, Pamukkale University
- Investigators
- Emel TAŞVURAN HORATA, MSc, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785639
- Sponsor's protocol ID
- 60116787-020/71491
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.
PubMed 20023000
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Contributing to Single and Dual Task Performance of Four Square Step Tests in the Healthy Middle Age Group
- ClinicalTrials.gov ID
- NCT03785639
- Acronym / sponsor ID
- 60116787-020/71491
- Conditions
- Aging
- Keywords
- balance, dual task, Four Square Step Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 24 Dec 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.
There are many tests that evaluate fall and balance. As a clinical test, the Four Square Step Test (FSST)Test is reliable, valid, easy to score, quick to administer, requires little space, and needs no special equipment. It is unique in that it involves stepping over low objects (2.5cm) and movement in 4 directions. FSST was developed in 2002 to measure the rapid stepping that is often required when changing direction and avoiding obstacles while walking. The FSST requires a stopwatch and four single point sticks. Using the sticks resting flat on the floor to form a cross, the subject starts in one square and steps in one direction into each of the four squares and then reverses direction back to the start. The FSST is unique in that it challenges motor planning, sequencing and recall, whilst simultaneously providing clinicians with the opportunity to measure and observe a person's clearance of low obstacles at speed. The ability to clear the trail leg when stepping over an obstacle has been shown to be reduced in healthy populations. Dual task is simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. Individuals have difficulties in performing two tasks together. When two tasks are performed at the same time, deterioration in performance of one or both is called dual task interference. This occurs when task requirements exceed the capacity. Age, walking speed, lower extremity muscle strength and cognitive status are factors that contribute to the dual task. In addition, prioritizing the motor or cognitive task in a dual task affects the dual task performance. Knowing these factors and improving some of them can help to create training programs designed to improve the dual task performance of individuals. There are several studies investigating factors contributing to dual task performance that focus on balance in the elderly. However, the studies including middle age group are limited. There are no studies evaluating the factors contributing to the single and dual task performance of FSST in the literature. In this study, it is aimed to explain the factors related to motor and cognitive functions to the single and dual task performance of FSST.
Detailed description
Participants: Healthy middle age group (50-65 years) Method: Demographic information of all participants (age, gender, body mass index), educational level (primary, undergraduate, graduate), history of falling (at least in 6 months), comorbidities (hypertension, diabetes, kidney diseases, etc.), drug using (how many per day, which one) to be examined by questionnaire and also visual impairment, the use of glasses will be recorded. Motor skills of participants; muscle strength, range of motion (ROM), gait speed (14m), Functional Reach Test will be evaluated. The Mini Mental Test and the Stroop test will be used to evaluate cognitive skills. Single and dual task performance will be evaluated by FSST.
The participants performed the FSST;
- FSST single: This test is consist of only FSST.
- FSST motor: FSST is combined with a motor task (carrying a cup of water)
- FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As prioritization affects dual task performance, in this study the prioritization will be used in dual task's evaluation. Therefore the dual task will be perform as;
1-With no prioritization 2-With prioritization (focus on balance task) 3-With prioritization (focus on cognitive task) 4-With prioritization (focus on motor task) Note: Balance task is FSST. Cognitive task is auditory N-back test. Motor task is carrying a cup of water.
Statistical Analyses:
The data will be analyzed with Statistical Package for the Social Sciences (SPSS) 21.0 package program. Descriptive statistical information will be given as mean (X) ± standard deviation (X ± SD) and minimum (min), maximum (max) frequency (f) and percentage (%). The variables will be tested for normality using the Kolmogorov-Smirnov test. When the parametrical test assumptions are obtained, the correlation between the FSST single, FSST motor and FSST cognitive is evaluated by Pearson Correlation Analysis, if the parametrical test assumptions are not obtained, Spearman Correlation Analysis will be used. Multiple linear regression analysis will be applied to determine which potential factor is effective in performance in each FSST test. As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 85% power could be obtained at 95% confidence level when at least 60 people.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty healthy active (joining social activities, sports and artistic activities etc.) participants (men and women) between the ages of 50-65 will be included in the study.
Key inclusion criteria (4 listed)
- At least to graduate from primary school or ability to read and write
- Mini mental test score> 24
- Functional reach test score≥15 cm
- Ability to walking independently in the community
Key exclusion criteria (5 listed)
- Living in nursing home
- Presence of central nervous system disease (dementia, Parkinson's disease, stroke, etc.)
- Polypharmacy (more than 6 medications per day)
- Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.
- Presence of musculoskeletal injuries or impairments (NEH limitation, muscle weakness, etc.), which may affect the performance in physical tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Strength
Time frame: 20 minutes
Grip strength and muscle strength of low extremities will be evaluated with using hand-held dynamometer. The measured value will be recorded in newton.
Range of motion
Time frame: 10 minutes
Range of motions of hip, knee and ankle will be assessed by goniometer.
Gait speed
Time frame: 2 minutes
Gait speed will be evaluated on a flat surface and at a distance of 14 meters. The walking speed will be recorded in m/sec.
Functional ReachTest
Time frame: 2 minutes
The FRT assesses limits of stability by measuring the maximum distance that an individual can reach forward while standing in a fixed position. A 122 cm ruler will be fastened to the wall with tape at the height of the subject's acromion process. The subject will be instructed to make a fist and raise the arm to 90 degrees of shoulder flexion. An initial measurement will be record at the position of the subject's third metacarpal. The subject will be instructed to reach as far forward as possible while keeping the fist parallel and level with the ruler and without taking a step or touching the wall.
Stroop Test
Time frame: 10 minutes
This test evaluate cognitive abilities. the Stroop Test is a useful measuring tool for especially the fields of psychiatry, neurology, neurosurgery, and clinical psychology and for the basic science field of experimental psychology. The test is used to evaluate cognitive processes such as frontal lobe functions and attention, information processing periods.
Four Square Step Test (FSST)
Time frame: 20 minutes
FSST is designed for assessing balance. The participants will be asked to stand in square number 1 facing square number 2 and to step clockwise forward, then right, backward and left, then anticlockwise right, forward and left and finally backward. The stopwatch will start when the first foot contacted the floor in square 2 and will finish when the last foot came back to touch the floor in square 1. Single and dual task performance will be evaluated by FSST. The participants performed the FSST; FSST single: This test is consist of only FSST. FSST motor: FSST is combined with a motor task (carrying a cup of water) FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As prioritization affects dual task performance, in this study the prioritization will be used in dual task's evaluation.
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 18 Sep 2020.
- Background: PubMed 20023000Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.
- Individual participant dataSharing planned: No
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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.
Emel TAŞVURAN HORATA, MSc principal investigator
Principal Investigator
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 Aging, run by Pamukkale 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 4 inclusion and 5 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 18 Sep 2020. 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?
Muscle Strength (time frame: 20 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785639, which also lists 1 linked publication.
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 18 Sep 2020.