<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/NCT03234998</url>
  </required_header>
  <id_info>
    <org_study_id>1612190002</org_study_id>
    <nct_id>NCT03234998</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy of Two Different Dual-task Balance Interventions</brief_title>
  <official_title>Comparative Efficacy of Two Different Dual-task Balance Interventions on Balance, Gait, and Cognitive Performance Under Single- and Dual-task Conditions in Stroke Patients and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung University</source>
  <oversight_info>
    <has_dmc>No</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>
      The objective of this study is to investigate the effects of two different dual-task balance&#xD;
      interventions for stroke patients and older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      English Synopsis&#xD;
&#xD;
      I. Title of Study:&#xD;
&#xD;
      Comparative efficacy of two different dual-task balance interventions on balance, gait, and&#xD;
      cognitive performance under single- and dual-task conditions in stroke patients and older&#xD;
      adults&#xD;
&#xD;
      II. Study Objectives:&#xD;
&#xD;
      The objective of this study is to investigate the effects of two different dual-task balance&#xD;
      interventions for stroke patients and older adults. Specifically, the investigators will&#xD;
      compare the immediate and retention effects of motor and cognitive dual-task balance training&#xD;
      [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under&#xD;
      single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim&#xD;
      2). The third aim of this study is to elucidate the mechanisms underlying changes in balance,&#xD;
      gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim&#xD;
      3).&#xD;
&#xD;
      III. Study Design A prospective randomized control trial will be conducted at medical centers&#xD;
      in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to&#xD;
      either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at&#xD;
      progressively increasing task difficulty (60 minutes per session, three times a week, for&#xD;
      four weeks). The CDT group will undertake dual-task balance training and concurrently perform&#xD;
      only cognitive tasks with instruction of a variable priority. The MCDT group will train the&#xD;
      same set of balance/gait activities as the CDT while simultaneously performing motor and&#xD;
      cognitive tasks with instruction of a variable priority. During each session, all&#xD;
      participants practice shifting attention between tasks by spending half of the training&#xD;
      attention focus on the balance task, and half focus on the secondary cognitive or motor&#xD;
      tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and&#xD;
      1-month follow-up. At baseline, all participants will be examined balance, gait, and&#xD;
      cognitive performance under single-task (standing, walking, cognitive tasks only) and&#xD;
      dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks&#xD;
      (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop&#xD;
      task, spatial memory task, and choice reaction time task) will be used to examine dual-task&#xD;
      performance because these tasks represent different domains of cognitive function&#xD;
      (information processing speed, working memory, and executive function). The primary outcome&#xD;
      measure of balance, gait, and cognition will be the sway index, gait speed, and composite&#xD;
      score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome&#xD;
      measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task&#xD;
      conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair&#xD;
      Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to&#xD;
      compare measurements at baseline, after training, and follow-up between the groups.&#xD;
&#xD;
      Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study:&#xD;
      2017/08/01～2020/07/31&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sway index</measure>
    <time_frame>10 minutes</time_frame>
    <description>Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gait speed</measure>
    <time_frame>5 minutes</time_frame>
    <description>Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary outcome measure will be gait speed (cm/s) under single- and dual-task conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>composite score</measure>
    <time_frame>10 minutes</time_frame>
    <description>Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cognitive-motor interference (CMI)</measure>
    <time_frame>20 minutes</time_frame>
    <description>The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: [(Dual-task - Single-task)/ Single-task *100] and for sway index using formula: [(Single-task - Dual-task)/ Single-task *100]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke.The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>2minutes</time_frame>
    <description>The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 meters, turn, walk back, and sit down again. The score is the mean time measured using a stopwatch if two trials to complete the test. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Gait Assessment (FGA)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity-specific Balance Confidence Scale (ABC)</measure>
    <time_frame>3 minutes</time_frame>
    <description>The ABC will be used to determine self-reported confidence when performing 16 different daily activities, such as walking around the house, walking up and down stairs, and walking on slippery floors. A confidence rating scale ranges from 0% to 100%, with 0% indicating no confidence, and 100% indicating full confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair Stand Test.</measure>
    <time_frame>1 minute</time_frame>
    <description>The Chair Stand Test measures lower extremity muscular strength.The participants will be instructed to stand from a seated on the chair position as much as possible for 30 seconds. The total number of stands was counted in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change Scale (PGIC)</measure>
    <time_frame>1 minute</time_frame>
    <description>Overall patient perception of MCDT or CDT will be evaluated using a Patient Global Impression of Change Scale (PGIC) regarding the participants' perception with the change in balance and gait related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their balance/gait now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Stroke</condition>
  <condition>Healthy Older Adults</condition>
  <arm_group>
    <arm_group_label>motor-cognitive dual-task training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cognitive dual-task training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>motor-cognitive dual-task training</intervention_name>
    <description>Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.</description>
    <arm_group_label>motor-cognitive dual-task training</arm_group_label>
    <other_name>MCDT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cognitive dual-task training</intervention_name>
    <description>Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.</description>
    <arm_group_label>cognitive dual-task training</arm_group_label>
    <other_name>CDT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Stroke Individuals:&#xD;
&#xD;
          -  first-ever stroke with onset duration more than 3 months&#xD;
&#xD;
          -  able to walk 10 m&#xD;
&#xD;
          -  no severe vision, hearing, and language problems&#xD;
&#xD;
        Inclusion Criteria for Healthy elderly:&#xD;
&#xD;
          -  more than 65 years old&#xD;
&#xD;
          -  able to walk 10 m&#xD;
&#xD;
          -  no neurological or musculoskeletal diagnosis&#xD;
&#xD;
          -  no severe vision, hearing, cognition, and language problems.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  orthopedic and other neurological disorders that affect walking&#xD;
&#xD;
          -  other treatments that could influence the effects of the interventions (e.g., recent&#xD;
             Botulin toxin treatment of the lower extremity)&#xD;
&#xD;
          -  moderate or severe cognitive impairments (score &lt;21 on Mini-Mental State Examination)&#xD;
&#xD;
          -  severe uncorrected visual deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Ling Chuang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung University</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung University</investigator_affiliation>
    <investigator_full_name>Li-Ling Chuang</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <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/NCT03234998
org study id: 1612190002
nct id: NCT03234998
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the effects of two different dual-task balance
      interventions for stroke patients and older adults.
English Synopsis

      I. Title of Study:

      Comparative efficacy of two different dual-task balance interventions on balance, gait, and
      cognitive performance under single- and dual-task conditions in stroke patients and older
      adults

      II. Study Objectives:

      The objective of this study is to investigate the effects of two different dual-task balance
      interventions for stroke patients and older adults. Specifically, the investigators will
      compare the immediate and retention effects of motor and cognitive dual-task balance training
      [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under
      single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim
      2). The third aim of this study is to elucidate the mechanisms underlying changes in balance,
      gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim
      3).

      III. Study Design A prospective randomized control trial will be conducted at medical centers
      in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to
      either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at
      progressively increasing task difficulty (60 minutes per session, three times a week, for
      four weeks). The CDT group will undertake dual-task balance training and concurrently perform
      only cognitive tasks with instruction of a variable priority. The MCDT group will train the
      same set of balance/gait activities as the CDT while simultaneously performing motor and
      cognitive tasks with instruction of a variable priority. During each session, all
      participants practice shifting attention between tasks by spending half of the training
      attention focus on the balance task, and half focus on the secondary cognitive or motor
      tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and
      1-month follow-up. At baseline, all participants will be examined balance, gait, and
      cognitive performance under single-task (standing, walking, cognitive tasks only) and
      dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks
      (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop
      task, spatial memory task, and choice reaction time task) will be used to examine dual-task
      performance because these tasks represent different domains of cognitive function
      (information processing speed, working memory, and executive function). The primary outcome
      measure of balance, gait, and cognition will be the sway index, gait speed, and composite
      score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome
      measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task
      conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair
      Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to
      compare measurements at baseline, after training, and follow-up between the groups.

      Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study:
      2017/08/01～2020/07/31
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: sway index
time frame: 10 minutes
description: Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.
measure: gait speed
time frame: 5 minutes
description: Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary outcome measure will be gait speed (cm/s) under single- and dual-task conditions.
measure: composite score
time frame: 10 minutes
description: Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.
measure: cognitive-motor interference (CMI)
time frame: 20 minutes
description: The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: [(Dual-task - Single-task)/ Single-task *100] and for sway index using formula: [(Single-task - Dual-task)/ Single-task *100]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.
measure: Berg Balance Scale (BBS)
time frame: 5-10 minutes
description: The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke.The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.
measure: Timed Up and Go Test
time frame: 2minutes
description: The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 meters, turn, walk back, and sit down again. The score is the mean time measured using a stopwatch if two trials to complete the test. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).
measure: Functional Gait Assessment (FGA)
time frame: 10 minutes
description: The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
measure: Activity-specific Balance Confidence Scale (ABC)
time frame: 3 minutes
description: The ABC will be used to determine self-reported confidence when performing 16 different daily activities, such as walking around the house, walking up and down stairs, and walking on slippery floors. A confidence rating scale ranges from 0% to 100%, with 0% indicating no confidence, and 100% indicating full confidence.
measure: Chair Stand Test.
time frame: 1 minute
description: The Chair Stand Test measures lower extremity muscular strength.The participants will be instructed to stand from a seated on the chair position as much as possible for 30 seconds. The total number of stands was counted in 30 seconds.
measure: Patient Global Impression of Change Scale (PGIC)
time frame: 1 minute
description: Overall patient perception of MCDT or CDT will be evaluated using a Patient Global Impression of Change Scale (PGIC) regarding the participants' perception with the change in balance and gait related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their balance/gait now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).
arm group label: motor-cognitive dual-task training
arm group type: Experimental
description: Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks.
arm group label: cognitive dual-task training
arm group type: Active Comparator
description: Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks.
intervention type: Device
intervention name: motor-cognitive dual-task training
description: Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.
arm group label: motor-cognitive dual-task training
other name: MCDT
intervention type: Device
intervention name: cognitive dual-task training
description: Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.
arm group label: cognitive dual-task training
other name: CDT
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li-Ling Chuang, PhD
role: Principal Investigator
affiliation: Chang Gung University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung University
investigator full name: Li-Ling Chuang
investigator title: Assistant Professor
mesh term: Stroke
sharing ipd: No