<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/NCT04507542</url>
  </required_header>
  <id_info>
    <org_study_id>201729.30</org_study_id>
    <nct_id>NCT04507542</nct_id>
  </id_info>
  <brief_title>Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke</brief_title>
  <acronym>HOMEMUSIC</acronym>
  <official_title>Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Artificial Intelligence Research Institute, Spanish National Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Barcelona</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>
      Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity&#xD;
      motor function of stroke patients through playing musical instruments. A modified version of&#xD;
      the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i)&#xD;
      a home-based self-training program using an app for electronic tablets and (ii) weekly group&#xD;
      sessions of musical playing strengthening the motivational and emotional components of music&#xD;
      playing. A randomised controlled trial will be conducted to test the effectiveness of this&#xD;
      enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being&#xD;
      and quality of life when compared to a program of home-based exercises utilizing the Graded&#xD;
      Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and&#xD;
      randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30).&#xD;
      Patients will be evaluated before and after a 10-week intervention, as well as at 3-month&#xD;
      follow-up. The primary outcome of the study is the functionality of the paretic upper limb&#xD;
      measured with the Action Research Arm Test. Secondary outcomes include other motor and&#xD;
      cognitive functions, emotional well-being and quality of life measures as well as&#xD;
      self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST&#xD;
      will show larger improvements in their motor and cognitive functions, emotional well-being&#xD;
      and quality of life than patients treated with a home-based GRASP intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>
    <intervention_model_description>A parallel-group randomised controlled trial will be conducted with participants being randomised to either an enriched Music-Supported Therapy group or to a control treatment group receiving the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A clinical researcher with expertise in stroke rehabilitation will perform the evaluations and will be blinded to participants' group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Action Research Arm Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Action Research Arm Test</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fugl-Meyer Assessment of Motor Recovery after Stroke</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fugl-Meyer Assessment of Motor Recovery after Stroke</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grip Strength in Kgs</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Grip strength measure, Biometrics E-Link tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grip Strength in Kgs</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Grip strength measure, Biometrics E-Link tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Box and Block Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Gross manual dexterity measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Box and Block Test</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Gross manual dexterity measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nine Hole Pegboard Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Fine manual dexterity measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nine Hole Pegboard Test</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Fine manual dexterity measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Chedoke Arm and Hand Activity Inventory</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Chedoke Arm and Hand Activity Inventory</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behaviour Rating Inventory of Executive Function</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behaviour Rating Inventory of Executive Function</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sustained Attention to Response Task</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Sustained attention measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sustained Attention to Response Task</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Sustained attention measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Figural Memory Subtest</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Visuospatial memory measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Figural Memory Subtest</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Visuospatial memory measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rey Auditory Verbal Learning Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Verbal learning measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rey Auditory Verbal Learning Test</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Verbal learning measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fluency Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Verbal fluency measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fluency Test</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Verbal fluency measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory-II</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory-II</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Apathy Evaluation Scale</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Apathy Evaluation Scale</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 &quot;not at all&quot; to 4 &quot;extremely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 &quot;not at all&quot; to 4 &quot;extremely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stroke Impact Scale</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stroke Impact Scale</measure>
    <time_frame>3 months after completing the intervention</time_frame>
    <description>Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Self-regulation Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-regulation measure. It evaluates the type of self-regulation (external, interjected, identified or intrinsic) or motivation (external or intrinsic) of the participants to engage with the rehabilitation program. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Questionnaire Concerning Continued Program</measure>
    <time_frame>Week 5 (after the first half of the intervention)</time_frame>
    <description>Self-regulation measure. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intrinsic Motivation Inventory</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Motivation measure. It consists of 24 self-report questions divided into six different psychological constructs reflecting positive or negative predictors of intrinsic motivation: 1) interest/enjoyment; 2) perceived competence; 3) effort/importance; 4) pressure/tension; 5) perceived choice; and 6) value/usefulness. It is scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).</description>
  </other_outcome>
  <other_outcome>
    <measure>Strategies Used to Promote Health Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-efficacy measure. It is a 29-item self-report questionnaire that evaluates the degree of self-care and self-efficacy through four factors consistent with the underlying self-efficacy theory upon which the scale is based: 1) coping, 2) stress reduction, 3) making decisions, and 4) enjoying life. It is scored on a 5-point scale (from 1: very little confidence to 5: quite a lot of confidence).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Enriched Music-Supported Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enriched Music-Supported Therapy</intervention_name>
    <description>Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.</description>
    <arm_group_label>Enriched Music-Supported Therapy group</arm_group_label>
    <other_name>Music-Supported Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Graded Repetitive Arm Supplementary Program</intervention_name>
    <description>Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>GRASP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Presence of mild-to-moderate paresis of the upper extremity after a stroke (having a&#xD;
             score between 1 and 4 in the Medical Research Council Scale for Muscle Strength at the&#xD;
             distal muscles of the upper extremity);&#xD;
&#xD;
          -  More than 6 months post-stroke;&#xD;
&#xD;
          -  Completion of formal rehabilitation programs.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Major language or cognitive deficits affecting comprehension (Mini-Mental State&#xD;
             Examination &lt; 24);&#xD;
&#xD;
          -  Neurological or psychiatric co-morbidity;&#xD;
&#xD;
          -  Other musculoskeletal condition affecting upper extremity motor function (e.g.&#xD;
             fracture or arthritis).&#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>Antoni Rodríguez Fornells, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bellvitge Biomedical Research Institute, University of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Grau Sánchez, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bellvitge Biomedical Research Institute, University of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antoni Rodríguez Fornells, PhD</last_name>
    <phone>+34934020489</phone>
    <email>antoni.rodriguez@icrea.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Grau Sánchez, PhD</last_name>
    <phone>+34934020489</phone>
    <email>jennifergrau@euit.fdsll.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bellvitge Biomedical Research Institute</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Research Office</last_name>
      <phone>+34932607411</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.brainvitge.org</url>
    <description>Research group webpage</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Barcelona</investigator_affiliation>
    <investigator_full_name>Antoni Rodriguez Fornells</investigator_full_name>
    <investigator_title>Research Professor in Catalan Institution for Research and Advanced Studies</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>music therapy</keyword>
  <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/NCT04507542
org study id: 201729.30
nct id: NCT04507542
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity
      motor function of stroke patients through playing musical instruments. A modified version of
      the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i)
      a home-based self-training program using an app for electronic tablets and (ii) weekly group
      sessions of musical playing strengthening the motivational and emotional components of music
      playing. A randomised controlled trial will be conducted to test the effectiveness of this
      enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being
      and quality of life when compared to a program of home-based exercises utilizing the Graded
      Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and
      randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30).
      Patients will be evaluated before and after a 10-week intervention, as well as at 3-month
      follow-up. The primary outcome of the study is the functionality of the paretic upper limb
      measured with the Action Research Arm Test. Secondary outcomes include other motor and
      cognitive functions, emotional well-being and quality of life measures as well as
      self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST
      will show larger improvements in their motor and cognitive functions, emotional well-being
      and quality of life than patients treated with a home-based GRASP intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A parallel-group randomised controlled trial will be conducted with participants being randomised to either an enriched Music-Supported Therapy group or to a control treatment group receiving the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: A clinical researcher with expertise in stroke rehabilitation will perform the evaluations and will be blinded to participants' group allocation.
measure: Change in Action Research Arm Test
time frame: immediately after the intervention
description: Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
measure: Change in Action Research Arm Test
time frame: 3 months after completing the intervention
description: Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
time frame: immediately after the intervention
description: Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
time frame: 3 months after completing the intervention
description: Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
measure: Change in Grip Strength in Kgs
time frame: immediately after the intervention
description: Grip strength measure, Biometrics E-Link tool
measure: Change in Grip Strength in Kgs
time frame: 3 months after completing the intervention
description: Grip strength measure, Biometrics E-Link tool
measure: Change in Box and Block Test
time frame: immediately after the intervention
description: Gross manual dexterity measure
measure: Change in Box and Block Test
time frame: 3 months after completing the intervention
description: Gross manual dexterity measure
measure: Change in Nine Hole Pegboard Test
time frame: immediately after the intervention
description: Fine manual dexterity measure
measure: Change in Nine Hole Pegboard Test
time frame: 3 months after completing the intervention
description: Fine manual dexterity measure
measure: Change in Chedoke Arm and Hand Activity Inventory
time frame: immediately after the intervention
description: Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
measure: Change in Chedoke Arm and Hand Activity Inventory
time frame: 3 months after completing the intervention
description: Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
measure: Change in Behaviour Rating Inventory of Executive Function
time frame: immediately after the intervention
description: Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
measure: Change in Behaviour Rating Inventory of Executive Function
time frame: 3 months after completing the intervention
description: Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
measure: Change in Sustained Attention to Response Task
time frame: immediately after the intervention
description: Sustained attention measure
measure: Change in Sustained Attention to Response Task
time frame: 3 months after completing the intervention
description: Sustained attention measure
measure: Change in Figural Memory Subtest
time frame: immediately after the intervention
description: Visuospatial memory measure
measure: Change in Figural Memory Subtest
time frame: 3 months after completing the intervention
description: Visuospatial memory measure
measure: Change in Rey Auditory Verbal Learning Test
time frame: immediately after the intervention
description: Verbal learning measure
measure: Change in Rey Auditory Verbal Learning Test
time frame: 3 months after completing the intervention
description: Verbal learning measure
measure: Change in Fluency Test
time frame: immediately after the intervention
description: Verbal fluency measure
measure: Change in Fluency Test
time frame: 3 months after completing the intervention
description: Verbal fluency measure
measure: Change in Beck Depression Inventory-II
time frame: immediately after the intervention
description: Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
measure: Change in Beck Depression Inventory-II
time frame: 3 months after completing the intervention
description: Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
measure: Change in Apathy Evaluation Scale
time frame: immediately after the intervention
description: Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
measure: Change in Apathy Evaluation Scale
time frame: 3 months after completing the intervention
description: Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
measure: Change in Profile of Mood States
time frame: immediately after the intervention
description: Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
measure: Change in Profile of Mood States
time frame: 3 months after completing the intervention
description: Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
measure: Change in Stroke Impact Scale
time frame: immediately after the intervention
description: Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
measure: Change in Stroke Impact Scale
time frame: 3 months after completing the intervention
description: Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
measure: Treatment Self-regulation Questionnaire
time frame: Baseline
description: Self-regulation measure. It evaluates the type of self-regulation (external, interjected, identified or intrinsic) or motivation (external or intrinsic) of the participants to engage with the rehabilitation program. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).
measure: Treatment Questionnaire Concerning Continued Program
time frame: Week 5 (after the first half of the intervention)
description: Self-regulation measure. It is a 15-item self-report questionnaire scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).
measure: Intrinsic Motivation Inventory
time frame: immediately after the intervention
description: Motivation measure. It consists of 24 self-report questions divided into six different psychological constructs reflecting positive or negative predictors of intrinsic motivation: 1) interest/enjoyment; 2) perceived competence; 3) effort/importance; 4) pressure/tension; 5) perceived choice; and 6) value/usefulness. It is scored on a 7-point scale (1: not all true; 4: somewhat true; 7: very true).
measure: Strategies Used to Promote Health Questionnaire
time frame: Baseline
description: Self-efficacy measure. It is a 29-item self-report questionnaire that evaluates the degree of self-care and self-efficacy through four factors consistent with the underlying self-efficacy theory upon which the scale is based: 1) coping, 2) stress reduction, 3) making decisions, and 4) enjoying life. It is scored on a 5-point scale (from 1: very little confidence to 5: quite a lot of confidence).
arm group label: Enriched Music-Supported Therapy group
arm group type: Experimental
description: Participants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours).
arm group label: Control group
arm group type: Active Comparator
description: Participants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours).
intervention type: Behavioral
intervention name: Enriched Music-Supported Therapy
description: Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.
arm group label: Enriched Music-Supported Therapy group
other name: Music-Supported Therapy
intervention type: Behavioral
intervention name: Graded Repetitive Arm Supplementary Program
description: Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.
arm group label: Control group
other name: GRASP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoni Rodríguez Fornells, PhD
role: Principal Investigator
affiliation: Bellvitge Biomedical Research Institute, University of Barcelona
last name: Jennifer Grau Sánchez, PhD
role: Study Director
affiliation: Bellvitge Biomedical Research Institute, University of Barcelona
last name: Antoni Rodríguez Fornells, PhD
phone: +34934020489
email: antoni.rodriguez@icrea.cat
last name: Jennifer Grau Sánchez, PhD
phone: +34934020489
email: jennifergrau@euit.fdsll.cat
facility: 
contact: 
country: Spain
url: http://www.brainvitge.org
description: Research group webpage
responsible party type: Principal Investigator
investigator affiliation: University of Barcelona
investigator full name: Antoni Rodriguez Fornells
investigator title: Research Professor in Catalan Institution for Research and Advanced Studies
mesh term: Stroke
sharing ipd: No