<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/NCT03246217</url>
  </required_header>
  <id_info>
    <org_study_id>#34521</org_study_id>
    <nct_id>NCT03246217</nct_id>
  </id_info>
  <brief_title>Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation</brief_title>
  <official_title>Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</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>
      Research has shown that music engages the brain bilaterally throughout cortical and&#xD;
      subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This&#xD;
      research explores the hypothesis that use of these shared neural networks allows neurologic&#xD;
      music therapy interventions targeting upper extremity motor control to promote plasticity and&#xD;
      functional improvements in persons recovering from a cerebrovascular accident. The potential&#xD;
      therapeutic benefits of these interventions on attentional processes and affective responding&#xD;
      will also be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More individuals are surviving and living with the effects of stroke, a trend that is&#xD;
      expected to continue. Upper extremity limitations present a common, persistent challenge for&#xD;
      stroke survivors, impacting quality of life. In addition, links have been found between&#xD;
      physical impairment and depression, and depression and stroke-induced cognitive impairment.&#xD;
      Music has been shown to exert multimodal effects on individuals and may be used as a&#xD;
      mediating stimulus to promote therapeutic change. Furthermore, motor imagery may enhance the&#xD;
      effectiveness of upper extremity interventions by engaging the same brain areas that are&#xD;
      active in physical movement. The purpose of this study is to investigate the effects of&#xD;
      therapeutic instrumental music performance and sensory-enhanced motor imagery on upper limb&#xD;
      movement, affect and cognition following a stroke. Participants will be assessed at two&#xD;
      baselines, and randomly assigned to one of three intervention groups: therapeutic&#xD;
      instrumental music performance, therapeutic instrumental music performance and&#xD;
      sensory-enhanced motor imagery, or therapeutic instrumental music performance and motor&#xD;
      imagery without sensory enhancement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in Wolf Motor Function Test</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Measures upper extremity motor ability through timed and functional tasks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in Fugl-Meyer Assessment Upper Extremity</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Performance based measure assessing motor capacity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Individuals rate quality and amount of movement during daily functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk Impairment Scale</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Affect Adjective Check List-Revised</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Measure of affective state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Assessment of perceived self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Span</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Assesses working memory and attention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test Part B</measure>
    <time_frame>Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks</time_frame>
    <description>Assesses mental flexibility and processing speed</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Therapeutic Instrumental Music Performance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic Instrumental Music Performance is a Neurologic Music Therapy technique in which selection of instruments, spatial configurations and sequences for playing are designed to facilitate retraining of movement patterns used in everyday life. Participants will receive nine individual forty-five minute sessions of Therapeutic Instrumental Music Performance, three sessions per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic Performance with Sensory-Enhanced Motor Imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of sensory-enhanced motor imagery. During sensory-enhanced motor imagery, participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic Performance with Motor Imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of motor imagery. Motor imagery will involve mental practice of previous movement exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapeutic Instrumental Music Performance</intervention_name>
    <description>Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.</description>
    <arm_group_label>Therapeutic Instrumental Music Performance</arm_group_label>
    <arm_group_label>Therapeutic Performance with Motor Imagery</arm_group_label>
    <arm_group_label>Therapeutic Performance with Sensory-Enhanced Motor Imagery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapeutic Performance with Sensory-Enhanced Motor Imagery</intervention_name>
    <description>Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.</description>
    <arm_group_label>Therapeutic Performance with Sensory-Enhanced Motor Imagery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapeutic Performance with Motor Imagery</intervention_name>
    <description>Participants will engage in motor imagery of previously practised movements.</description>
    <arm_group_label>Therapeutic Performance with Motor Imagery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hemiparesis following a unilateral stroke (hemorrhagic or ischemic), sustained more&#xD;
             than 6 months prior, with at least minimal volitional movement of the affected limb&#xD;
&#xD;
          -  permission from a physician to participate in an upper extremity rehabilitation&#xD;
             program, including confirmation that the following disorders are not present:&#xD;
             rheumatoid arthritis, upper extremity fracture, apraxia, neuropathy, somatosensory&#xD;
             impairment&#xD;
&#xD;
          -  adequate language comprehension and neurocognitive function to understand and follow&#xD;
             simple instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently enrolled in an upper extremity rehabilitation program or another upper&#xD;
             extremity study&#xD;
&#xD;
          -  comorbid neurological disorder (e.g. multiple sclerosis, Parkinson's disease)&#xD;
&#xD;
          -  evidence of perceptual or cognitive impairment; e.g., unilateral spatial neglect,&#xD;
             significant hearing impairment, Montreal Cognitive Assessment score of 25 or less&#xD;
&#xD;
          -  presence of aphasia&#xD;
&#xD;
          -  injections for spasticity within three months of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Thaut, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Music, University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S2C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Catherine Haire</investigator_full_name>
    <investigator_title>PhD Candidate</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/NCT03246217
org study id: #34521
nct id: NCT03246217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research has shown that music engages the brain bilaterally throughout cortical and
      subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This
      research explores the hypothesis that use of these shared neural networks allows neurologic
      music therapy interventions targeting upper extremity motor control to promote plasticity and
      functional improvements in persons recovering from a cerebrovascular accident. The potential
      therapeutic benefits of these interventions on attentional processes and affective responding
      will also be examined.
More individuals are surviving and living with the effects of stroke, a trend that is
      expected to continue. Upper extremity limitations present a common, persistent challenge for
      stroke survivors, impacting quality of life. In addition, links have been found between
      physical impairment and depression, and depression and stroke-induced cognitive impairment.
      Music has been shown to exert multimodal effects on individuals and may be used as a
      mediating stimulus to promote therapeutic change. Furthermore, motor imagery may enhance the
      effectiveness of upper extremity interventions by engaging the same brain areas that are
      active in physical movement. The purpose of this study is to investigate the effects of
      therapeutic instrumental music performance and sensory-enhanced motor imagery on upper limb
      movement, affect and cognition following a stroke. Participants will be assessed at two
      baselines, and randomly assigned to one of three intervention groups: therapeutic
      instrumental music performance, therapeutic instrumental music performance and
      sensory-enhanced motor imagery, or therapeutic instrumental music performance and motor
      imagery without sensory enhancement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes from baseline in Wolf Motor Function Test
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Measures upper extremity motor ability through timed and functional tasks.
measure: Changes from baseline in Fugl-Meyer Assessment Upper Extremity
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Performance based measure assessing motor capacity.
measure: Motor Activity Log
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Individuals rate quality and amount of movement during daily functional tasks.
measure: Trunk Impairment Scale
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale
measure: Multiple Affect Adjective Check List-Revised
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Measure of affective state
measure: General Self-Efficacy Scale
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Assessment of perceived self-efficacy
measure: Digit Span
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Assesses working memory and attention
measure: Trail Making Test Part B
time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
description: Assesses mental flexibility and processing speed
arm group label: Therapeutic Instrumental Music Performance
arm group type: Experimental
description: Therapeutic Instrumental Music Performance is a Neurologic Music Therapy technique in which selection of instruments, spatial configurations and sequences for playing are designed to facilitate retraining of movement patterns used in everyday life. Participants will receive nine individual forty-five minute sessions of Therapeutic Instrumental Music Performance, three sessions per week.
arm group label: Therapeutic Performance with Sensory-Enhanced Motor Imagery
arm group type: Experimental
description: Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of sensory-enhanced motor imagery. During sensory-enhanced motor imagery, participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
arm group label: Therapeutic Performance with Motor Imagery
arm group type: Experimental
description: Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of motor imagery. Motor imagery will involve mental practice of previous movement exercises.
intervention type: Behavioral
intervention name: Therapeutic Instrumental Music Performance
description: Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
arm group label: Therapeutic Instrumental Music Performance
arm group label: Therapeutic Performance with Motor Imagery
arm group label: Therapeutic Performance with Sensory-Enhanced Motor Imagery
intervention type: Behavioral
intervention name: Therapeutic Performance with Sensory-Enhanced Motor Imagery
description: Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
arm group label: Therapeutic Performance with Sensory-Enhanced Motor Imagery
intervention type: Behavioral
intervention name: Therapeutic Performance with Motor Imagery
description: Participants will engage in motor imagery of previously practised movements.
arm group label: Therapeutic Performance with Motor Imagery
criteria: 
gender: All
minimum age: 30 Years
maximum age: 79 Years
healthy volunteers: No
last name: Michael Thaut, PhD
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Catherine Haire
investigator title: PhD Candidate
mesh term: Stroke
sharing ipd: No