<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/NCT01721668</url>
  </required_header>
  <id_info>
    <org_study_id>REB1213</org_study_id>
    <nct_id>NCT01721668</nct_id>
  </id_info>
  <brief_title>Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)</brief_title>
  <official_title>Examination of Therapeutic Intervention Methods on the Brain Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baycrest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baycrest</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improving arm and hand function after stroke has been difficult to achieve within the&#xD;
      rehabilitation service provided in the acute stage often due to the limited resource in&#xD;
      health care. While spontaneous recovery plateaus after 6 months, the prolonged disability&#xD;
      affects quality of life and social participation in stroke survivors. This study is aimed at&#xD;
      improving chronic motor impairment arm and hand impairment by providing the intervention with&#xD;
      intensive training schedule. This study will compare two types of rehabilitation intervention&#xD;
      using a randomized controlled trial. Measurements also will be taken on various brain&#xD;
      functions non-invasively to help discover how each of the intervention strategies works&#xD;
      differently to repair the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After unilateral stroke, incomplete recovery of arm and hand movement is common and its&#xD;
      long-lasting negative effects include increased care giving costs and overall reduced quality&#xD;
      of life. Recent evidence suggests that a novel behavioral intervention could improve motor&#xD;
      functions in sub-acute patients with added benefits in cognitive and brain functions. However&#xD;
      few studies have addressed whether chronic stage patients can also benefit from the&#xD;
      intervention and how brain plasticity works over the course of rehabilitation. This study&#xD;
      will investigate the benefits of two types of intervention methods that are extendable for&#xD;
      community-based intervention services in the future. It also will examine changes in&#xD;
      integrity of motions before and after the intervention. Further comparisons between brain&#xD;
      functions and structure will be made using magnetoencephalography (MEG) and magnetic&#xD;
      resonance imaging (MRI), non-invasively. These behavioural and physiological measures will&#xD;
      inform the mechanisms of stroke recovery and training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in performance on Action Research Arm Test</measure>
    <time_frame>Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up</time_frame>
    <description>Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in performance on Chedoke Arm and Hand Inventory</measure>
    <time_frame>Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up</time_frame>
    <description>Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in status on Stroke Impact Scale</measure>
    <time_frame>Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up</time_frame>
    <description>Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain structure</measure>
    <time_frame>Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up</time_frame>
    <description>Structural MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Function</measure>
    <time_frame>Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up</time_frame>
    <description>Brain functions related to sensory and motor systems assessed by MEG</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Stroke</condition>
  <condition>Upper Extremity Paresis</condition>
  <arm_group>
    <arm_group_label>MSR - Music Supported Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: Music Supported Rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CU/ET</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experimental: CU/ET (Conventional Upper Extremity Therapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music Supported Rehabilitation</intervention_name>
    <description>Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.</description>
    <arm_group_label>MSR - Music Supported Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Upper Extremity Therapy</intervention_name>
    <description>-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.</description>
    <arm_group_label>CU/ET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post-acute stroke patients with unilateral first-time MCA stroke sustained . (more&#xD;
             than 6 months ago prior to the enrolment to the study).&#xD;
&#xD;
          -  Patients' residual motor impairments in the affected hand and arm should be greater&#xD;
             than stage 3 on the Chedoke McMaster scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory&#xD;
             loss in the paretic hand, severe language-communication disability, posture problems,&#xD;
             involuntary movements, high-blood pressure, depression or other psychological&#xD;
             disorders, metal in body that interferes with MEG and MRI measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deirdre R Dawson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baycrest</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernhard Ross, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baycrest</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Takako Fujioka, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baycrest Centre for Geriatric Care</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6A2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baycrest</investigator_affiliation>
    <investigator_full_name>Dr. Deirdre Dawson</investigator_full_name>
    <investigator_title>Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01721668
org study id: REB1213
nct id: NCT01721668
lead sponsor: 
has dmc: Yes
Improving arm and hand function after stroke has been difficult to achieve within the
      rehabilitation service provided in the acute stage often due to the limited resource in
      health care. While spontaneous recovery plateaus after 6 months, the prolonged disability
      affects quality of life and social participation in stroke survivors. This study is aimed at
      improving chronic motor impairment arm and hand impairment by providing the intervention with
      intensive training schedule. This study will compare two types of rehabilitation intervention
      using a randomized controlled trial. Measurements also will be taken on various brain
      functions non-invasively to help discover how each of the intervention strategies works
      differently to repair the brain.
After unilateral stroke, incomplete recovery of arm and hand movement is common and its
      long-lasting negative effects include increased care giving costs and overall reduced quality
      of life. Recent evidence suggests that a novel behavioral intervention could improve motor
      functions in sub-acute patients with added benefits in cognitive and brain functions. However
      few studies have addressed whether chronic stage patients can also benefit from the
      intervention and how brain plasticity works over the course of rehabilitation. This study
      will investigate the benefits of two types of intervention methods that are extendable for
      community-based intervention services in the future. It also will examine changes in
      integrity of motions before and after the intervention. Further comparisons between brain
      functions and structure will be made using magnetoencephalography (MEG) and magnetic
      resonance imaging (MRI), non-invasively. These behavioural and physiological measures will
      inform the mechanisms of stroke recovery and training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in performance on Action Research Arm Test
time frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
description: Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
measure: Change in performance on Chedoke Arm and Hand Inventory
time frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
description: Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
measure: Change in status on Stroke Impact Scale
time frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
description: Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
measure: Brain structure
time frame: Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up
description: Structural MRI
measure: Brain Function
time frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
description: Brain functions related to sensory and motor systems assessed by MEG
arm group label: MSR - Music Supported Rehabilitation
arm group type: Experimental
description: Behavioral: Music Supported Rehabilitation
arm group label: CU/ET
arm group type: Active Comparator
description: Experimental: CU/ET (Conventional Upper Extremity Therapy)
intervention type: Behavioral
intervention name: Music Supported Rehabilitation
description: Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.
arm group label: MSR - Music Supported Rehabilitation
intervention type: Behavioral
intervention name: Conventional Upper Extremity Therapy
description: -GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.
arm group label: CU/ET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deirdre R Dawson, PhD
role: Principal Investigator
affiliation: Baycrest
last name: Bernhard Ross, PhD
role: Principal Investigator
affiliation: Baycrest
last name: Takako Fujioka, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Baycrest
investigator full name: Dr. Deirdre Dawson
investigator title: Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute
mesh term: Paresis