<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/NCT01681888</url>
  </required_header>
  <id_info>
    <org_study_id>Biofeedback2012</org_study_id>
    <nct_id>NCT01681888</nct_id>
  </id_info>
  <brief_title>Surface EMG Biofeedback for Children With Cerebral Palsy</brief_title>
  <official_title>Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent&#xD;
      voluntary movement. Studies have suggested that using biofeedback to increase awareness of&#xD;
      muscle activation can improve motor function in patients with motor deficits. The&#xD;
      investigators hypothesize that the daily use of a surface electromyographic (SEMG)&#xD;
      biofeedback device for one month will improve motor function in children and young adults&#xD;
      with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the&#xD;
      muscle(s) the subject has difficulty in controlling and provides vibratory feedback about&#xD;
      muscle activation. Groups of children and young adults (ages 3-21), with dystonia,&#xD;
      hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory&#xD;
      feedback device on their affected muscle(s) for 5 hours a day for one month. The device will&#xD;
      vibrate and emit a blue light when the muscle is activated. At the start of the experiment,&#xD;
      subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes&#xD;
      Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one&#xD;
      month, subjects will practice goals without device. After a month, subject will be assessed&#xD;
      again and be given device to practice goals for a month. After one month, the subjects will&#xD;
      be tested on the outcome measures again and return device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 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>Goal Attainment Scale</measure>
    <time_frame>Two months</time_frame>
    <description>The Goal Attainment Scale measures function in each of 5 areas that are individually chosen by the parents or adolescents at the initial visit. Parents and/or adolescents are encouraged to choose 2 basic movement goals and 3 goals related to function.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Dystonia</condition>
  <condition>Hypertonia</condition>
  <condition>Spasticity</condition>
  <condition>Movement Disorders</condition>
  <arm_group>
    <arm_group_label>Surface EMG Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sanger EMG Biofeedback Device</intervention_name>
    <arm_group_label>Surface EMG Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cerebral palsy, or associated movement disorders such as dystonia, spasticity, and/or&#xD;
             hypertonia&#xD;
&#xD;
          -  Able to wear device for given amount of time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to wear device for at least 5 hours day for a month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terence Sanger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aprille Tongol, B.A.</last_name>
    <phone>213-740-1317</phone>
    <email>tongol@usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diana Ferman, P.A.</last_name>
    <phone>310-425-2342</phone>
    <email>dferman@usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aprille Tongol, B.A.</last_name>
      <phone>213-740-1317</phone>
      <email>tongol@usc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Diana Ferman, P.A.</last_name>
      <phone>310-425-2342</phone>
      <email>dferman@usc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Terence Sanger, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Terence Sanger</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681888
org study id: Biofeedback2012
nct id: NCT01681888
lead sponsor: 
has dmc: No
Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent
      voluntary movement. Studies have suggested that using biofeedback to increase awareness of
      muscle activation can improve motor function in patients with motor deficits. The
      investigators hypothesize that the daily use of a surface electromyographic (SEMG)
      biofeedback device for one month will improve motor function in children and young adults
      with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the
      muscle(s) the subject has difficulty in controlling and provides vibratory feedback about
      muscle activation. Groups of children and young adults (ages 3-21), with dystonia,
      hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory
      feedback device on their affected muscle(s) for 5 hours a day for one month. The device will
      vibrate and emit a blue light when the muscle is activated. At the start of the experiment,
      subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes
      Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one
      month, subjects will practice goals without device. After a month, subject will be assessed
      again and be given device to practice goals for a month. After one month, the subjects will
      be tested on the outcome measures again and return device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Goal Attainment Scale
time frame: Two months
description: The Goal Attainment Scale measures function in each of 5 areas that are individually chosen by the parents or adolescents at the initial visit. Parents and/or adolescents are encouraged to choose 2 basic movement goals and 3 goals related to function.
arm group label: Surface EMG Biofeedback
arm group type: Experimental
intervention type: Device
intervention name: Sanger EMG Biofeedback Device
arm group label: Surface EMG Biofeedback
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Terence Sanger, MD, PhD
role: Principal Investigator
affiliation: University of Southern California
last name: Aprille Tongol, B.A.
phone: 213-740-1317
email: tongol@usc.edu
last name: Diana Ferman, P.A.
phone: 310-425-2342
email: dferman@usc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Terence Sanger
investigator title: Associate Professor
mesh term: Cerebral Palsy
mesh term: Dystonia
mesh term: Movement Disorders