<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/NCT03306797</url>
  </required_header>
  <id_info>
    <org_study_id>2088 CE</org_study_id>
    <nct_id>NCT03306797</nct_id>
  </id_info>
  <brief_title>Music Therapy for Rehabilitation in Stroke Patients</brief_title>
  <acronym>SONICHAND</acronym>
  <official_title>Hand Rehabilitation With Music Therapy Technique (Sonification) and Leap Motion Controller in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</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 study uses a specific hand tracking sensor (Leap Motion Controller) to catch the&#xD;
      movements of the arm combined with proper pre-defined musical patterns (sonification) in a&#xD;
      neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of&#xD;
      sonification technique (compared to usual care) in the hand rehabilitation of patients with&#xD;
      stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Every year in Italy occur over than 200.000 new stroke cases. The virtual and augmented&#xD;
      reality offers a valid support to the rehabilitation program by providing objectives&#xD;
      parameters for the patient evaluation, accelerating the motor recovery process and enhancing&#xD;
      the motor performance after the discharge. This study uses a specific hand tracking sensor&#xD;
      (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined&#xD;
      musical patterns (sonification) in a neurologic music therapy perspective.&#xD;
&#xD;
      In addition to its use in relational contexts, in fact, music therapy is widely used in the&#xD;
      field of rehabilitation, and in particular in the neuromotor rehabilitation, due to the&#xD;
      impact of the sound, as well as on paralimbic and limbic areas, the areas of the brain&#xD;
      involved in the movements (motor cortex, supplementary motor area, cerebellum, basal ganglia,&#xD;
      etc.).&#xD;
&#xD;
      Recent studies uses sonification for the rehabilitation of the upper limbs assuming a&#xD;
      replacement of the proprioceptive aspects damaged by the disease thanks to the audio-motor&#xD;
      feedback. This study, furthermore, exploits the specificities of the Leap Motion Controller&#xD;
      and the peculiarities of the sound stimuli that accompany the arm movement without requiring&#xD;
      cognitive tasks.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To verify through a randomized controlled trial and a suitable motor assessment the&#xD;
           efficacy of the rehabilitation of the hand in patients with stroke using the&#xD;
           &quot;sonification&quot; technique&#xD;
&#xD;
        -  To verify whether the &quot;sonification&quot; technique reduces the fatigue and the pain&#xD;
           perceived during rehabilitation&#xD;
&#xD;
        -  Assess the impact of &quot;sonification&quot; technique on patients quality of life&#xD;
&#xD;
      Materials and Methods:&#xD;
&#xD;
      In this randomized controlled trial 66 patients with stroke will be recruited and allocated&#xD;
      in 2 groups. The control group will be undergone to a 35 minutes standard daily&#xD;
      rehabilitation treatment lasting 4 weeks. The experimental group will be undergone to an&#xD;
      analogue treatment based on 15 minutes of standard rehabilitation and 20 minutes of exercises&#xD;
      with sonification. Randomisation will be centralized for the four Units involved in the&#xD;
      study.&#xD;
&#xD;
      The intervention will be assessed in blind at the baseline (T0), at the mid-treatment period&#xD;
      (T1 = 2 weeks), at the end of the treatment (T2 = 4 weeks), and at a follow-up point (T3 = 8&#xD;
      weeks).&#xD;
&#xD;
      The following assessment tools will be used:&#xD;
&#xD;
        -  Fugl-Meyer Motor Assessment Scale&#xD;
&#xD;
        -  Box and Block Test&#xD;
&#xD;
        -  Modified Ashworth Scale&#xD;
&#xD;
        -  Visual Analogue Scale (VAS)&#xD;
&#xD;
        -  Numerical Pain Rating Scale&#xD;
&#xD;
        -  McGill Quality of Life&#xD;
&#xD;
      At T0, T1, T2 and T3 some motion parameters will be recorded and monitored by the Leap Motion&#xD;
      Controller to evaluate possible changes in the movements execution.&#xD;
&#xD;
      Statistics:&#xD;
&#xD;
      The Intention-To-Treat (ITT) population will be considered for the analysis. An unpaired&#xD;
      Student's t test on the pre (T0)-post treatment (T2) differences will be used to assess the&#xD;
      primary endpoint. Longitudinal trends over time will be assessed through repeated measures&#xD;
      analysis of variance. Other analyses will be available in the statistical analysis plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 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>Fugl-Meyer Motor Assessment Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Primary endpoint of the study is given by the measurement of proximal and distal upper limb motor skills assessed by the Fugl-Meyer Motor Assessment Scale. The primary endpoint will be assessed by comparing the variation between T0 and T2 of the scale scores above mentioned in the experimental and control groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Box and Block Test (BBT)</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Assessment of unilateral gross manual dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Measurement of spasticity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Evaluation of perceived fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Pain Rating Scale (NPRS)</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Assessment of pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGill Quality of Life</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Assessment of Quality of Life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Stroke</condition>
  <condition>Hand Injuries</condition>
  <arm_group>
    <arm_group_label>SONICHAND</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises (4 weeks, daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STANDARD REHAB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>STANDARD REHAB</intervention_name>
    <description>The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training with at least 6 exercises selected from:&#xD;
wrist&#xD;
ulnarization radialization&#xD;
prono-supination&#xD;
horizontal flexion-extension&#xD;
vertical flexion-extension hand&#xD;
grasping&#xD;
pinching&#xD;
extensors&#xD;
interosseous shoulder-elbow&#xD;
vertical flexion-extension&#xD;
push forward</description>
    <arm_group_label>STANDARD REHAB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SONICHAND</intervention_name>
    <description>The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises selected from the list. The Leap Motion Controller is managed with an ad-hoc developed application that is able to associate the movements with a 4 notes arpeggio or with a modulated texture.&#xD;
With the first mode the movement produces and modulates an harmonic progression built on the consecutive grades of the major scale played as ascending and descending arpeggio with also a volume crescendo and decrescendo.&#xD;
With the second mode, the movement modulates the volume and the low-pass cutoff frequency of a synthetic texture.</description>
    <arm_group_label>SONICHAND</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40-85 years old&#xD;
&#xD;
          -  ischemic lesion in one hemisphere (hemiplegia / hemiparesis right or left)&#xD;
&#xD;
          -  Mini Mental State Examination &gt; 24 onset acute event not later than 180 days prior to&#xD;
             study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dated lesions beyond 6 months from onset&#xD;
&#xD;
          -  Multiple or bilateral lesions&#xD;
&#xD;
          -  Mini Mental State Examination &lt;24&#xD;
&#xD;
          -  Presence of neglect&#xD;
&#xD;
          -  Previous or concomitant disabling diseases for upper limb function (Eg: Parkinson's&#xD;
             disease, multiple sclerosis, shoulder's periarthritis, Dupuytren's disease, etc.)&#xD;
&#xD;
          -  Previous rehabilitative treatments with music&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ICS Maugeri, Nervi Institute</name>
      <address>
        <city>Genoa</city>
        <state>Genova</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICS Maugeri, Montescano Institute</name>
      <address>
        <city>Montescano</city>
        <state>Pavia</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICS Maugeri, Pavia Institute</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Santa Lucia IRCCS</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Music therapy</keyword>
  <keyword>Sonification technique</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hand Injuries</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/NCT03306797
org study id: 2088 CE
nct id: NCT03306797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study uses a specific hand tracking sensor (Leap Motion Controller) to catch the
      movements of the arm combined with proper pre-defined musical patterns (sonification) in a
      neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of
      sonification technique (compared to usual care) in the hand rehabilitation of patients with
      stroke.
Introduction:

      Every year in Italy occur over than 200.000 new stroke cases. The virtual and augmented
      reality offers a valid support to the rehabilitation program by providing objectives
      parameters for the patient evaluation, accelerating the motor recovery process and enhancing
      the motor performance after the discharge. This study uses a specific hand tracking sensor
      (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined
      musical patterns (sonification) in a neurologic music therapy perspective.

      In addition to its use in relational contexts, in fact, music therapy is widely used in the
      field of rehabilitation, and in particular in the neuromotor rehabilitation, due to the
      impact of the sound, as well as on paralimbic and limbic areas, the areas of the brain
      involved in the movements (motor cortex, supplementary motor area, cerebellum, basal ganglia,
      etc.).

      Recent studies uses sonification for the rehabilitation of the upper limbs assuming a
      replacement of the proprioceptive aspects damaged by the disease thanks to the audio-motor
      feedback. This study, furthermore, exploits the specificities of the Leap Motion Controller
      and the peculiarities of the sound stimuli that accompany the arm movement without requiring
      cognitive tasks.

      Objectives:

        -  To verify through a randomized controlled trial and a suitable motor assessment the
           efficacy of the rehabilitation of the hand in patients with stroke using the
           "sonification" technique

        -  To verify whether the "sonification" technique reduces the fatigue and the pain
           perceived during rehabilitation

        -  Assess the impact of "sonification" technique on patients quality of life

      Materials and Methods:

      In this randomized controlled trial 66 patients with stroke will be recruited and allocated
      in 2 groups. The control group will be undergone to a 35 minutes standard daily
      rehabilitation treatment lasting 4 weeks. The experimental group will be undergone to an
      analogue treatment based on 15 minutes of standard rehabilitation and 20 minutes of exercises
      with sonification. Randomisation will be centralized for the four Units involved in the
      study.

      The intervention will be assessed in blind at the baseline (T0), at the mid-treatment period
      (T1 = 2 weeks), at the end of the treatment (T2 = 4 weeks), and at a follow-up point (T3 = 8
      weeks).

      The following assessment tools will be used:

        -  Fugl-Meyer Motor Assessment Scale

        -  Box and Block Test

        -  Modified Ashworth Scale

        -  Visual Analogue Scale (VAS)

        -  Numerical Pain Rating Scale

        -  McGill Quality of Life

      At T0, T1, T2 and T3 some motion parameters will be recorded and monitored by the Leap Motion
      Controller to evaluate possible changes in the movements execution.

      Statistics:

      The Intention-To-Treat (ITT) population will be considered for the analysis. An unpaired
      Student's t test on the pre (T0)-post treatment (T2) differences will be used to assess the
      primary endpoint. Longitudinal trends over time will be assessed through repeated measures
      analysis of variance. Other analyses will be available in the statistical analysis plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Motor Assessment Scale
time frame: 4 weeks
description: Primary endpoint of the study is given by the measurement of proximal and distal upper limb motor skills assessed by the Fugl-Meyer Motor Assessment Scale. The primary endpoint will be assessed by comparing the variation between T0 and T2 of the scale scores above mentioned in the experimental and control groups.
measure: Box and Block Test (BBT)
time frame: up to 8 weeks
description: Assessment of unilateral gross manual dexterity
measure: Modified Ashworth Scale
time frame: up to 8 weeks
description: Measurement of spasticity
measure: Visual Analogue Scale (VAS)
time frame: up to 8 weeks
description: Evaluation of perceived fatigue
measure: Numerical Pain Rating Scale (NPRS)
time frame: up to 8 weeks
description: Assessment of pain intensity
measure: McGill Quality of Life
time frame: up to 8 weeks
description: Assessment of Quality of Life
arm group label: SONICHAND
arm group type: Experimental
description: The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises (4 weeks, daily)
arm group label: STANDARD REHAB
arm group type: Other
description: The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily)
intervention type: Other
intervention name: STANDARD REHAB
description: The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training with at least 6 exercises selected from:
wrist
ulnarization radialization
prono-supination
horizontal flexion-extension
vertical flexion-extension hand
grasping
pinching
extensors
interosseous shoulder-elbow
vertical flexion-extension
push forward
arm group label: STANDARD REHAB
intervention type: Device
intervention name: SONICHAND
description: The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises selected from the list. The Leap Motion Controller is managed with an ad-hoc developed application that is able to associate the movements with a 4 notes arpeggio or with a modulated texture.
With the first mode the movement produces and modulates an harmonic progression built on the consecutive grades of the major scale played as ascending and descending arpeggio with also a volume crescendo and decrescendo.
With the second mode, the movement modulates the volume and the low-pass cutoff frequency of a synthetic texture.
arm group label: SONICHAND
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Italy
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responsible party type: Sponsor
mesh term: Stroke
mesh term: Hand Injuries
sharing ipd: No