<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/NCT03777111</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/53283</org_study_id>
    <nct_id>NCT03777111</nct_id>
  </id_info>
  <brief_title>Effect of Single and Dual Task Training on Gait, Balance and Functional Mobility</brief_title>
  <official_title>Effect of Single and Double Task Training on Gait, Balance and Functional Mobility in the Elderly: Randomized Controlled Study</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>
      Most of the daily life activities include dual task performance. Unlike conventional&#xD;
      physiotherapy approaches, dual task training aims to improve both motor performance and&#xD;
      cognitive performance at the same time. Geriatric rehabilitation approaches in Turkey; single&#xD;
      task training (containing only motor performance) is applied to older adults for walking and&#xD;
      balance disorders. Recent studies have shown gait parameters and balance abilities are&#xD;
      influenced cognitive function and also dual task training is had to include in rehabilitation&#xD;
      programs in order to improve walking and balance skills of the healthy elderly. In Turkey, a&#xD;
      similar study is not found. The goal of this study is to evaluate in healthy elderly, effect&#xD;
      of dual-task and single-task training on gait performance, and their effect on the balance&#xD;
      abilities and functional mobility also to evaluate advantages one to another and to gain a&#xD;
      different perspective to geriatric rehabilitation for the elderly in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol:&#xD;
&#xD;
      In this study, the demographic information (age, gender, body mass index, education level,&#xD;
      occupation, etc.) of all participants will be recorded first. In the first evaluation, the&#xD;
      participants' gait parameters will be determined by using the 10-meter walking test and the&#xD;
      wearable sensors. Balance is evaluated by Functional Reach Test, One Leg Stand Test and&#xD;
      Tinetti Balance and Gait Assessment. Cognitive skills will be evaluated by using Mini Mental&#xD;
      Test and Stroop Test. After the first evaluations of the participants, the participants will&#xD;
      be given single or dual task training for 6 weeks, 2 times a week, not on consecutive days.&#xD;
      If participants are absent for any training session, a compensation training session will be&#xD;
      organized for them. After completing the single and / or dual task training, the final&#xD;
      evaluations will be made. Randomization will be performed according to age, gender and body&#xD;
      mass index of participants. After the randomization, participants' training group will be&#xD;
      determined. Warm-up and cooling exercises will be carried out between 5-10 minutes before and&#xD;
      after each training. Each training will consist of approximately 45-60 minutes including&#xD;
      warm-up and cooling exercise periods. Each exercise starts with 5 repetitions and proceeds to&#xD;
      10 repetitions. To reduce the effects of fatigue and to draw attention, a break time that&#xD;
      consists of approximately 1-2 minutes will be given.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      The effect size obtained in the reference study was strong (d = 1.16). As a result of the&#xD;
      power analysis using the effect size value in the reference study for the study, it was&#xD;
      calculated that 80% power could be obtained at 95% confidence level when at least 20 people&#xD;
      (10 people per group) were included the study. The data will be analyzed with Statistical&#xD;
      Package for the Social Sciences (SPSS) package program. Continuous variables will be given as&#xD;
      mean ± standard deviation and categorical variables as number and percentage. In the&#xD;
      independent group comparisons, if the parametrical test assumptions are obtained, independent&#xD;
      samples t-test will be used if the parametric test assumptions are not obtained Mann Whitney&#xD;
      U test will be used. In the dependent group comparisons, when the parametric test assumptions&#xD;
      are obtained, paired samples t-test; if not obtained Wilcoxon tests will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">January 13, 2021</completion_date>
  <primary_completion_date type="Actual">January 13, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>10 meter walk test</measure>
    <time_frame>six week</time_frame>
    <description>This test will perform with wearable gait sensors and will evaluate gait parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Reach Test</measure>
    <time_frame>six week</time_frame>
    <description>Balance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>One Leg stand Test</measure>
    <time_frame>six week</time_frame>
    <description>Balance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tinetti balance and gait assessment</measure>
    <time_frame>six week</time_frame>
    <description>For evaluating balance and gait</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroop test</measure>
    <time_frame>six week</time_frame>
    <description>cognitive test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Single Task Training Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gait and balance exercises will be applied in single task training group.&#xD;
Semi-tandem, tandem stand with eyes open and close&#xD;
One leg stance with eyes open and close&#xD;
Gait exercises; walking forwards, backwards, sidewards, semi-tandem and tandem walking&#xD;
Reaching forward and sidewards with eyes open and close</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual Task Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The exercises given in the single task training group will be combined with the cognitive tasks.&#xD;
Semi-tandem, tandem stand with recall a sequence of numbers&#xD;
One leg stance with writing pre-defined letters or words with other foot&#xD;
Semi-tandem or tandem walking with saying previous number (one or two previous) from number that researcher has given before&#xD;
Walking sidewards with collecting numbers that researcher has given&#xD;
Walking backwards with counting forward by one (then two or three)&#xD;
Reaching forward with counting backward one (then two or three)&#xD;
Reaching sidewards with saying next number (one or two next) from number that researcher has given before</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Single Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks.</description>
    <arm_group_label>Dual Task Training Group</arm_group_label>
    <arm_group_label>Single Task Training Group</arm_group_label>
  </intervention>
  <eligibility>
    <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;
          -  Ability to achieve daily living activities independently&#xD;
&#xD;
          -  Ability to walk independently in the community (at least 10 meters without walking&#xD;
             aids)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of acute (fracture, surgery), chronic (Parkinson's diseases, diabetes or&#xD;
             stroke) and cognitive (Alzheimer, dementia, etc.) diseases&#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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suat EREL</last_name>
    <role>Study Director</role>
    <affiliation>PhD</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>Shin SS, An DH. The Effect of Motor Dual-task Balance Training on Balance and Gait of Elderly Women. J Phys Ther Sci. 2014 Mar;26(3):359-61. doi: 10.1589/jpts.26.359. Epub 2014 Mar 25.</citation>
    <PMID>24707083</PMID>
  </reference>
  <reference>
    <citation>Brustio PR, Rabaglietti E, Formica S, Liubicich ME. Dual-task training in older adults: The effect of additional motor tasks on mobility performance. Arch Gerontol Geriatr. 2018 Mar-Apr;75:119-124. doi: 10.1016/j.archger.2017.12.003. Epub 2017 Dec 10.</citation>
    <PMID>29245071</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Emel TAŞVURAN HORATA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Aging</keyword>
  <keyword>gait</keyword>
  <keyword>balance</keyword>
  <keyword>functional mobility</keyword>
  <keyword>dual task training</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/NCT03777111
org study id: 60116787-020/53283
nct id: NCT03777111
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Most of the daily life activities include dual task performance. Unlike conventional
      physiotherapy approaches, dual task training aims to improve both motor performance and
      cognitive performance at the same time. Geriatric rehabilitation approaches in Turkey; single
      task training (containing only motor performance) is applied to older adults for walking and
      balance disorders. Recent studies have shown gait parameters and balance abilities are
      influenced cognitive function and also dual task training is had to include in rehabilitation
      programs in order to improve walking and balance skills of the healthy elderly. In Turkey, a
      similar study is not found. The goal of this study is to evaluate in healthy elderly, effect
      of dual-task and single-task training on gait performance, and their effect on the balance
      abilities and functional mobility also to evaluate advantages one to another and to gain a
      different perspective to geriatric rehabilitation for the elderly in Turkey.
Protocol:

      In this study, the demographic information (age, gender, body mass index, education level,
      occupation, etc.) of all participants will be recorded first. In the first evaluation, the
      participants' gait parameters will be determined by using the 10-meter walking test and the
      wearable sensors. Balance is evaluated by Functional Reach Test, One Leg Stand Test and
      Tinetti Balance and Gait Assessment. Cognitive skills will be evaluated by using Mini Mental
      Test and Stroop Test. After the first evaluations of the participants, the participants will
      be given single or dual task training for 6 weeks, 2 times a week, not on consecutive days.
      If participants are absent for any training session, a compensation training session will be
      organized for them. After completing the single and / or dual task training, the final
      evaluations will be made. Randomization will be performed according to age, gender and body
      mass index of participants. After the randomization, participants' training group will be
      determined. Warm-up and cooling exercises will be carried out between 5-10 minutes before and
      after each training. Each training will consist of approximately 45-60 minutes including
      warm-up and cooling exercise periods. Each exercise starts with 5 repetitions and proceeds to
      10 repetitions. To reduce the effects of fatigue and to draw attention, a break time that
      consists of approximately 1-2 minutes will be given.

      Statistical Analysis:

      The effect size obtained in the reference study was strong (d = 1.16). As a result of the
      power analysis using the effect size value in the reference study for the study, it was
      calculated that 80% power could be obtained at 95% confidence level when at least 20 people
      (10 people per group) were included the study. The data will be analyzed with Statistical
      Package for the Social Sciences (SPSS) package program. Continuous variables will be given as
      mean ± standard deviation and categorical variables as number and percentage. In the
      independent group comparisons, if the parametrical test assumptions are obtained, independent
      samples t-test will be used if the parametric test assumptions are not obtained Mann Whitney
      U test will be used. In the dependent group comparisons, when the parametric test assumptions
      are obtained, paired samples t-test; if not obtained Wilcoxon tests will be used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 10 meter walk test
time frame: six week
description: This test will perform with wearable gait sensors and will evaluate gait parameters.
measure: Functional Reach Test
time frame: six week
description: Balance test
measure: One Leg stand Test
time frame: six week
description: Balance test
measure: Tinetti balance and gait assessment
time frame: six week
description: For evaluating balance and gait
measure: Stroop test
time frame: six week
description: cognitive test
arm group label: Single Task Training Group
arm group type: Active Comparator
description: Gait and balance exercises will be applied in single task training group.
Semi-tandem, tandem stand with eyes open and close
One leg stance with eyes open and close
Gait exercises; walking forwards, backwards, sidewards, semi-tandem and tandem walking
Reaching forward and sidewards with eyes open and close
arm group label: Dual Task Training Group
arm group type: Experimental
description: The exercises given in the single task training group will be combined with the cognitive tasks.
Semi-tandem, tandem stand with recall a sequence of numbers
One leg stance with writing pre-defined letters or words with other foot
Semi-tandem or tandem walking with saying previous number (one or two previous) from number that researcher has given before
Walking sidewards with collecting numbers that researcher has given
Walking backwards with counting forward by one (then two or three)
Reaching forward with counting backward one (then two or three)
Reaching sidewards with saying next number (one or two next) from number that researcher has given before
intervention type: Other
intervention name: Exercise
description: Single Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks.
arm group label: Dual Task Training Group
arm group label: Single Task Training Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suat EREL
role: Study Director
affiliation: PhD
facility: 
country: Turkey
citation: Shin SS, An DH. The Effect of Motor Dual-task Balance Training on Balance and Gait of Elderly Women. J Phys Ther Sci. 2014 Mar;26(3):359-61. doi: 10.1589/jpts.26.359. Epub 2014 Mar 25.
PMID: 24707083
citation: Brustio PR, Rabaglietti E, Formica S, Liubicich ME. Dual-task training in older adults: The effect of additional motor tasks on mobility performance. Arch Gerontol Geriatr. 2018 Mar-Apr;75:119-124. doi: 10.1016/j.archger.2017.12.003. Epub 2017 Dec 10.
PMID: 29245071
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Emel TAŞVURAN HORATA
investigator title: Principal Investigator
sharing ipd: No