<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/NCT01709188</url>
  </required_header>
  <id_info>
    <org_study_id>101-2201B</org_study_id>
    <secondary_id>20216</secondary_id>
    <nct_id>NCT01709188</nct_id>
  </id_info>
  <brief_title>Musical Dual Task Training to Improve Attention Control for Dementia</brief_title>
  <official_title>The Effects of Musical Dual Task Training on Attention Control and Associated Gait Stability of Patients With Mild to Moderate Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to determine if the Musical Dual Task Training program&#xD;
      improves attention control that influences measures of gait performances under dual tasking,&#xD;
      balance, fear of falling, and behavioral disturbance in patients with mild to moderate&#xD;
      dementia. This Musical Dual Task Training protocol is structured with musical content and&#xD;
      patients are required to do musical tasks including singing and playing instruments&#xD;
      contingent on visual or auditory cues while walking. This paradigm is designed to include&#xD;
      music making because it involves great demands on attention and memory that might elicit&#xD;
      experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to&#xD;
      strengthen brain networking for attention control that consequently may improve the gait&#xD;
      performances in patients with dementia, as indicated by reducing dual task cost on gait.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline on the Trail Making Test at 2 months</measure>
    <time_frame>Baseline and at 2 months</time_frame>
    <description>Trail Making Test Part A requires the participants to draw lines to connect a set of 25 circles as fast as possible following the sequential order of numbers (1,2,3…25) while still maintaining accuracy. Trail Making Test Part B is in a same format, but participants are required to alternates between numbers and letters (1, A, 2, B, etc.). The circles in Part B include both numbers (1 - 13) and letters (A - L). Results for both Part A and Part B are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on Walking Speed during Dual tasking at 2 Months</measure>
    <time_frame>Baseline and at 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Timed Up-and-Go test at 2 Months</measure>
    <time_frame>Baseline and 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months</measure>
    <time_frame>Baseline and at 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months</measure>
    <time_frame>Baseline and at 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on Stride Lengths during Dual Tasking at 2 Months</measure>
    <time_frame>Baseline and at 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Musical Dual Task Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist. Within the Musical Dual Task Training session, participant will be asked to sing familiar songs, play simple percussive musical instruments such as paddle drums and shakers, sing while walking, and play instruments while walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking and Talking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist. Within the walking and talking session, participant will be asked to read a newspaper article prior to a walk and have a conversation with the music therapist based on the content of the news while walking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Musical Dual Task Training</intervention_name>
    <arm_group_label>Musical Dual Task Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking and Talking</intervention_name>
    <arm_group_label>Walking and Talking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a mild to moderate dementia diagnosis with Clinical Dementia Rating (CDR) score: .5,&#xD;
             1, or 2&#xD;
&#xD;
          -  ability to walk 10 meters independently without the use of a walker or cane, or the&#xD;
             assistance by another person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other known neurologic disorders such as stroke or Parkinson's disease&#xD;
&#xD;
          -  significant orthopedic, visual, and hearing impairment that hinders ambulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Cheng Pei, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Medical Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu-Cheng Pei, MD, PhD</last_name>
    <phone>886-3-3281200</phone>
    <phone_ext>3846</phone_ext>
    <email>yspeii@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yu-Ling Chen, MA, MME</last_name>
    <phone>886-922123809</phone>
    <email>yuling1015@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu-Cheng Pei, MD, PhD</last_name>
      <phone>886-3-3281200</phone>
      <phone_ext>3846</phone_ext>
      <email>yspeii@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Yu-Cheng Pei, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Musical Dual Task Training</keyword>
  <keyword>dementia</keyword>
  <keyword>attention control</keyword>
  <keyword>dual task cost</keyword>
  <keyword>gait stability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 10, 2014</submitted>
    <returned>July 10, 2014</returned>
    <submitted>June 13, 2016</submitted>
    <returned>July 21, 2016</returned>
  </pending_results>
  <!-- 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/NCT01709188
org study id: 101-2201B
secondary id: 20216
nct id: NCT01709188
lead sponsor: 
has dmc: Yes
The purpose of this project is to determine if the Musical Dual Task Training program
      improves attention control that influences measures of gait performances under dual tasking,
      balance, fear of falling, and behavioral disturbance in patients with mild to moderate
      dementia. This Musical Dual Task Training protocol is structured with musical content and
      patients are required to do musical tasks including singing and playing instruments
      contingent on visual or auditory cues while walking. This paradigm is designed to include
      music making because it involves great demands on attention and memory that might elicit
      experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to
      strengthen brain networking for attention control that consequently may improve the gait
      performances in patients with dementia, as indicated by reducing dual task cost on gait.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline on the Trail Making Test at 2 months
time frame: Baseline and at 2 months
description: Trail Making Test Part A requires the participants to draw lines to connect a set of 25 circles as fast as possible following the sequential order of numbers (1,2,3…25) while still maintaining accuracy. Trail Making Test Part B is in a same format, but participants are required to alternates between numbers and letters (1, A, 2, B, etc.). The circles in Part B include both numbers (1 - 13) and letters (A - L). Results for both Part A and Part B are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
measure: Change from Baseline on Walking Speed during Dual tasking at 2 Months
time frame: Baseline and at 2 months
measure: Change from Baseline on the Timed Up-and-Go test at 2 Months
time frame: Baseline and 2 months
measure: Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months
time frame: Baseline and at 2 months
measure: Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months
time frame: Baseline and at 2 months
measure: Change from Baseline on Stride Lengths during Dual Tasking at 2 Months
time frame: Baseline and at 2 months
arm group label: Musical Dual Task Training
arm group type: Experimental
description: 60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist. Within the Musical Dual Task Training session, participant will be asked to sing familiar songs, play simple percussive musical instruments such as paddle drums and shakers, sing while walking, and play instruments while walking.
arm group label: Walking and Talking
arm group type: Active Comparator
description: 60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist. Within the walking and talking session, participant will be asked to read a newspaper article prior to a walk and have a conversation with the music therapist based on the content of the news while walking.
intervention type: Behavioral
intervention name: Musical Dual Task Training
arm group label: Musical Dual Task Training
intervention type: Behavioral
intervention name: Walking and Talking
arm group label: Walking and Talking
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Cheng Pei, MD, PhD
role: Principal Investigator
affiliation: Chang Gung Medical Foundation
last name: Yu-Cheng Pei, MD, PhD
phone: 886-3-3281200
phone ext: 3846
email: yspeii@gmail.com
last name: Yu-Ling Chen, MA, MME
phone: 886-922123809
email: yuling1015@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Dementia
submitted: June 10, 2014
returned: July 10, 2014
submitted: June 13, 2016
returned: July 21, 2016