<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/NCT03778398</url>
  </required_header>
  <id_info>
    <org_study_id>IMU FTR</org_study_id>
    <nct_id>NCT03778398</nct_id>
  </id_info>
  <brief_title>Music Therapy In Adolescents With Cerebral Palsy</brief_title>
  <official_title>The Effect Of Music Therapy On Upper Extremity Functions In Adolescents With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medeniyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</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>
      Purpose of the study;&#xD;
&#xD;
        -  To improve the upper extremity motor functions of patients with adolescent cerebral&#xD;
           palsy,&#xD;
&#xD;
        -  Prevent treatment interruptions as age progresses,&#xD;
&#xD;
        -  Increase the hand functions of children with cerebral palsy and to increase their living&#xD;
           standards.&#xD;
&#xD;
      Hand functions will be assessed with MACS (Manual Ability Classification System), hand&#xD;
      dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI&#xD;
      (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per&#xD;
      week, total 3 months of customized piano training. Each session will be started with finger&#xD;
      warming exercises, then with the right hand, left handed and with both hands, a simple&#xD;
      pentatonic array will be played. In the following lessons, notes will be marked with colors&#xD;
      and simple songs will be taught. At the end of 3 months, the tests will be repeated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy is the development, movement and posture disorder that causes the limitation&#xD;
      of activity which is thought to be caused by non-progressive disorders in the fetal or infant&#xD;
      brain. Intensive rehabilitation program begins in early childhood; However, adults with&#xD;
      cerebral palsy are less likely to receive rehabilitative interventions. There is a great need&#xD;
      for effective upper extremity rehabilitation studies that motivate the patient in CP&#xD;
      (cerebral palsy) rehabilitation after childhood. Therapeutic Instrumental Music Performance&#xD;
      (TIMP) is one of the three techniques of neurological music therapy techniques for motor&#xD;
      rehabilitation. This technique uses instruments to strengthen functional motor patterns.&#xD;
      There are very few studies on TIMP in individuals with cerebral palsy and these studies have&#xD;
      not been performed on patients with adolescent cerebral palsy.&#xD;
&#xD;
      Purpose of the study;&#xD;
&#xD;
        -  To improve the upper extremity motor functions of patients with adolescent cerebral&#xD;
           palsy,&#xD;
&#xD;
        -  Prevent treatment interruptions as age progresses,&#xD;
&#xD;
        -  Increase the hand functions of children with cerebral palsy and to increase their living&#xD;
           standards.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        -  Being 11-18 years old&#xD;
&#xD;
        -  To be diagnosed with cerebral palsy&#xD;
&#xD;
        -  Not have been previously trained piano&#xD;
&#xD;
        -  To have enough cognitive function to perform commands&#xD;
&#xD;
        -  Accepted to participate in the study&#xD;
&#xD;
      Criteria for not being included in research:&#xD;
&#xD;
        -  Having cognitive disorder&#xD;
&#xD;
        -  Advanced visual impairment, visual field defect&#xD;
&#xD;
        -  To be previously trained for piano&#xD;
&#xD;
        -  Another disease preventing upper extremity movements&#xD;
&#xD;
      Hand functions will be assessed with MACS (Manual Ability Classification System), hand&#xD;
      dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI&#xD;
      (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per&#xD;
      week, total 3 months of customized piano training. Each session will be started with finger&#xD;
      warming exercises, then with the right hand, left handed and with both hands, a simple&#xD;
      pentatonic array will be played. In the following lessons, notes will be marked with colors&#xD;
      and simple songs will be taught. At the end of 3 months, the tests will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2018</start_date>
  <completion_date type="Anticipated">March 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved hand function</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement on MACS (Manual Ability Classification System)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved hand strength</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement on hand dynamometer and pressing velocities measured by Cubase MIDI (musical instrument data interface) program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved fine motor skills</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement on box-block test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved fine motor skills</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement on 9 hole peg test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved hand coordination</measure>
    <time_frame>3 months</time_frame>
    <description>observational, development of the ability to play the piano with two hands</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Neurologic music therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurologic music therapy</intervention_name>
    <description>Customized piano training</description>
    <arm_group_label>Neurologic music therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being 11-18 years old&#xD;
&#xD;
          -  To be diagnosed with cerebral palsy&#xD;
&#xD;
          -  Not have been previously trained piano&#xD;
&#xD;
          -  To have enough cognitive function to perform commands&#xD;
&#xD;
          -  Accepted to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having cognitive disorder&#xD;
&#xD;
          -  Advanced visual impairment, visual field defect&#xD;
&#xD;
          -  To be previously trained for piano&#xD;
&#xD;
          -  Another disease preventing upper extremity movements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bilinç Doğruöz Karatekin, MD</last_name>
    <phone>+905368308709</phone>
    <email>bilincdogruoz@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department</name>
      <address>
        <city>Istanbul</city>
        <zip>34732</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bilinç Doğruöz Karatekin</last_name>
      <phone>+905368308709</phone>
      <email>bilincdogruoz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Bilinç Doğruöz Karatekin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Afitap İçağasıoğlu, MD, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Bilinç Doğruöz Karatekin</investigator_full_name>
    <investigator_title>MD, Research Assistant of PMR</investigator_title>
  </responsible_party>
  <keyword>music therapy</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>piano training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</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/NCT03778398
org study id: IMU FTR
nct id: NCT03778398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of the study;

        -  To improve the upper extremity motor functions of patients with adolescent cerebral
           palsy,

        -  Prevent treatment interruptions as age progresses,

        -  Increase the hand functions of children with cerebral palsy and to increase their living
           standards.

      Hand functions will be assessed with MACS (Manual Ability Classification System), hand
      dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI
      (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per
      week, total 3 months of customized piano training. Each session will be started with finger
      warming exercises, then with the right hand, left handed and with both hands, a simple
      pentatonic array will be played. In the following lessons, notes will be marked with colors
      and simple songs will be taught. At the end of 3 months, the tests will be repeated.
Cerebral palsy is the development, movement and posture disorder that causes the limitation
      of activity which is thought to be caused by non-progressive disorders in the fetal or infant
      brain. Intensive rehabilitation program begins in early childhood; However, adults with
      cerebral palsy are less likely to receive rehabilitative interventions. There is a great need
      for effective upper extremity rehabilitation studies that motivate the patient in CP
      (cerebral palsy) rehabilitation after childhood. Therapeutic Instrumental Music Performance
      (TIMP) is one of the three techniques of neurological music therapy techniques for motor
      rehabilitation. This technique uses instruments to strengthen functional motor patterns.
      There are very few studies on TIMP in individuals with cerebral palsy and these studies have
      not been performed on patients with adolescent cerebral palsy.

      Purpose of the study;

        -  To improve the upper extremity motor functions of patients with adolescent cerebral
           palsy,

        -  Prevent treatment interruptions as age progresses,

        -  Increase the hand functions of children with cerebral palsy and to increase their living
           standards.

      Inclusion Criteria:

        -  Being 11-18 years old

        -  To be diagnosed with cerebral palsy

        -  Not have been previously trained piano

        -  To have enough cognitive function to perform commands

        -  Accepted to participate in the study

      Criteria for not being included in research:

        -  Having cognitive disorder

        -  Advanced visual impairment, visual field defect

        -  To be previously trained for piano

        -  Another disease preventing upper extremity movements

      Hand functions will be assessed with MACS (Manual Ability Classification System), hand
      dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI
      (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per
      week, total 3 months of customized piano training. Each session will be started with finger
      warming exercises, then with the right hand, left handed and with both hands, a simple
      pentatonic array will be played. In the following lessons, notes will be marked with colors
      and simple songs will be taught. At the end of 3 months, the tests will be repeated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improved hand function
time frame: 3 months
description: Improvement on MACS (Manual Ability Classification System)
measure: Improved hand strength
time frame: 3 months
description: Improvement on hand dynamometer and pressing velocities measured by Cubase MIDI (musical instrument data interface) program
measure: Improved fine motor skills
time frame: 3 months
description: Improvement on box-block test
measure: Improved fine motor skills
time frame: 3 months
description: Improvement on 9 hole peg test
measure: Improved hand coordination
time frame: 3 months
description: observational, development of the ability to play the piano with two hands
arm group label: Neurologic music therapy
arm group type: Experimental
description: Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught.
intervention type: Other
intervention name: Neurologic music therapy
description: Customized piano training
arm group label: Neurologic music therapy
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: No
last name: Bilinç Doğruöz Karatekin, MD
phone: +905368308709
email: bilincdogruoz@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Bilinç Doğruöz Karatekin
investigator title: MD, Research Assistant of PMR
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No