<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03785639</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/71491</org_study_id>
    <nct_id>NCT03785639</nct_id>
  </id_info>
  <brief_title>Factors Contributing to Single and Dual Task Performance of Four Square Step Tests</brief_title>
  <official_title>Factors Contributing to Single and Dual Task Performance of Four Square Step Tests in the Healthy Middle Age Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are many tests that evaluate fall and balance. As a clinical test, the Four Square Step&#xD;
      Test (FSST)Test is reliable, valid, easy to score, quick to administer, requires little&#xD;
      space, and needs no special equipment. It is unique in that it involves stepping over low&#xD;
      objects (2.5cm) and movement in 4 directions. FSST was developed in 2002 to measure the rapid&#xD;
      stepping that is often required when changing direction and avoiding obstacles while walking.&#xD;
      The FSST requires a stopwatch and four single point sticks. Using the sticks resting flat on&#xD;
      the floor to form a cross, the subject starts in one square and steps in one direction into&#xD;
      each of the four squares and then reverses direction back to the start. The FSST is unique in&#xD;
      that it challenges motor planning, sequencing and recall, whilst simultaneously providing&#xD;
      clinicians with the opportunity to measure and observe a person's clearance of low obstacles&#xD;
      at speed. The ability to clear the trail leg when stepping over an obstacle has been shown to&#xD;
      be reduced in healthy populations. Dual task is simultaneous performance of two tasks that&#xD;
      can be performed independently, measured separately and with different goals. Individuals&#xD;
      have difficulties in performing two tasks together. When two tasks are performed at the same&#xD;
      time, deterioration in performance of one or both is called dual task interference. This&#xD;
      occurs when task requirements exceed the capacity. Age, walking speed, lower extremity muscle&#xD;
      strength and cognitive status are factors that contribute to the dual task. In addition,&#xD;
      prioritizing the motor or cognitive task in a dual task affects the dual task performance.&#xD;
      Knowing these factors and improving some of them can help to create training programs&#xD;
      designed to improve the dual task performance of individuals. There are several studies&#xD;
      investigating factors contributing to dual task performance that focus on balance in the&#xD;
      elderly. However, the studies including middle age group are limited. There are no studies&#xD;
      evaluating the factors contributing to the single and dual task performance of FSST in the&#xD;
      literature. In this study, it is aimed to explain the factors related to motor and cognitive&#xD;
      functions to the single and dual task performance of FSST.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: Healthy middle age group (50-65 years) Method: Demographic information of all&#xD;
      participants (age, gender, body mass index), educational level (primary, undergraduate,&#xD;
      graduate), history of falling (at least in 6 months), comorbidities (hypertension, diabetes,&#xD;
      kidney diseases, etc.), drug using (how many per day, which one) to be examined by&#xD;
      questionnaire and also visual impairment, the use of glasses will be recorded. Motor skills&#xD;
      of participants; muscle strength, range of motion (ROM), gait speed (14m), Functional Reach&#xD;
      Test will be evaluated. The Mini Mental Test and the Stroop test will be used to evaluate&#xD;
      cognitive skills. Single and dual task performance will be evaluated by FSST.&#xD;
&#xD;
      The participants performed the FSST;&#xD;
&#xD;
        1. FSST single: This test is consist of only FSST.&#xD;
&#xD;
        2. FSST motor: FSST is combined with a motor task (carrying a cup of water)&#xD;
&#xD;
        3. FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As&#xD;
           prioritization affects dual task performance, in this study the prioritization will be&#xD;
           used in dual task's evaluation. Therefore the dual task will be perform as;&#xD;
&#xD;
      1-With no prioritization 2-With prioritization (focus on balance task) 3-With prioritization&#xD;
      (focus on cognitive task) 4-With prioritization (focus on motor task) Note: Balance task is&#xD;
      FSST. Cognitive task is auditory N-back test. Motor task is carrying a cup of water.&#xD;
&#xD;
      Statistical Analyses:&#xD;
&#xD;
      The data will be analyzed with Statistical Package for the Social Sciences (SPSS) 21.0&#xD;
      package program. Descriptive statistical information will be given as mean (X) ± standard&#xD;
      deviation (X ± SD) and minimum (min), maximum (max) frequency (f) and percentage (%). The&#xD;
      variables will be tested for normality using the Kolmogorov-Smirnov test. When the&#xD;
      parametrical test assumptions are obtained, the correlation between the FSST single, FSST&#xD;
      motor and FSST cognitive is evaluated by Pearson Correlation Analysis, if the parametrical&#xD;
      test assumptions are not obtained, Spearman Correlation Analysis will be used. Multiple&#xD;
      linear regression analysis will be applied to determine which potential factor is effective&#xD;
      in performance in each FSST test. As a result of the power analysis using the effect size&#xD;
      value in the reference study for the study, it was calculated that 85% power could be&#xD;
      obtained at 95% confidence level when at least 60 people.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>20 minutes</time_frame>
    <description>Grip strength and muscle strength of low extremities will be evaluated with using hand-held dynamometer. The measured value will be recorded in newton.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>10 minutes</time_frame>
    <description>Range of motions of hip, knee and ankle will be assessed by goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait speed</measure>
    <time_frame>2 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional ReachTest</measure>
    <time_frame>2 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>10 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Four Square Step Test (FSST)</measure>
    <time_frame>20 minutes</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Aging</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Sixty healthy active (joining social activities, sports and artistic activities etc.)&#xD;
        participants (men and women) between the ages of 50-65 will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least to graduate from primary school or ability to read and write&#xD;
&#xD;
          -  Mini mental test score&gt; 24&#xD;
&#xD;
          -  Functional reach test score≥15 cm&#xD;
&#xD;
          -  Ability to walking independently in the community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Living in nursing home&#xD;
&#xD;
          -  Presence of central nervous system disease (dementia, Parkinson's disease, stroke,&#xD;
             etc.)&#xD;
&#xD;
          -  Polypharmacy (more than 6 medications per day)&#xD;
&#xD;
          -  Presence of hearing impairment that cannot be resolved by hearing devices and presence&#xD;
             visual impairment that cannot be resolved by hearing aids.&#xD;
&#xD;
          -  Presence of musculoskeletal injuries or impairments (NEH limitation, muscle weakness,&#xD;
             etc.), which may affect the performance in physical tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emel TAŞVURAN HORATA, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University</name>
      <address>
        <city>Denizli</city>
        <state>Kınıklı</state>
        <zip>20160</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20023000</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Suat EREL</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>balance</keyword>
  <keyword>dual task</keyword>
  <keyword>Four Square Step Test</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03785639
org study id: 60116787-020/71491
nct id: NCT03785639
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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;

        1. FSST single: This test is consist of only FSST.

        2. FSST motor: FSST is combined with a motor task (carrying a cup of water)

        3. 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.
observational model: Cohort
time perspective: Prospective
measure: Muscle Strength
time frame: 20 minutes
description: Grip strength and muscle strength of low extremities will be evaluated with using hand-held dynamometer. The measured value will be recorded in newton.
measure: Range of motion
time frame: 10 minutes
description: Range of motions of hip, knee and ankle will be assessed by goniometer.
measure: Gait speed
time frame: 2 minutes
description: 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.
measure: Functional ReachTest
time frame: 2 minutes
description: 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.
measure: Stroop Test
time frame: 10 minutes
description: 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.
measure: Four Square Step Test (FSST)
time frame: 20 minutes
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emel TAŞVURAN HORATA, MSc
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: Turkey
citation: 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.
PMID: 20023000
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Suat EREL
investigator title: Principal Investigator
sharing ipd: No