<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/NCT02242994</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00003767</org_study_id>
    <nct_id>NCT02242994</nct_id>
  </id_info>
  <brief_title>Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Axel Krieger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's National Research Institute</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate a touch screen application designed to help&#xD;
      pediatric patients with cerebral palsy communicate. The study will test how well patients&#xD;
      type on two different tools: one tool is already on the market , and the second tool is a&#xD;
      newly developed App.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed of Communication</measure>
    <time_frame>Immediately</time_frame>
    <description>Measure time (in minutes) to type 3 pre-set sentences</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Error Rate of Communication</measure>
    <time_frame>At time of experiment</time_frame>
    <description>Amount of typing errors per sentence</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Dynavox Maestro and Experimental App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynavox Maestro</intervention_name>
    <description>Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.</description>
    <arm_group_label>Dynavox Maestro and Experimental App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Experimental App</intervention_name>
    <description>Participant receives experimental app to test speed and error rate of communication.</description>
    <arm_group_label>Dynavox Maestro and Experimental App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 7 years old - 21 years old&#xD;
&#xD;
          -  been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.&#xD;
&#xD;
          -  are able to communicate through written words&#xD;
&#xD;
          -  are able to follow a 3- steps directions, and follow study directions and procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's National</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>October 24, 2016</results_first_submitted>
  <results_first_submitted_qc>October 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 14, 2016</results_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
    <investigator_full_name>Axel Krieger</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dynavox Maestro and Experimental App</title>
          <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.&#xD;
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.&#xD;
Experimental App: Participant receives experimental app to test speed and error rate of communication.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Age 7-21</population>
      <group_list>
        <group group_id="B1">
          <title>Dynavox Maestro and Experimental App</title>
          <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.&#xD;
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.&#xD;
Experimental App: Participant receives experimental app to test speed and error rate of communication.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Speed of Communication</title>
        <description>Measure time (in minutes) to type 3 pre-set sentences</description>
        <time_frame>Immediately</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynavox Maestro and Experimental App</title>
            <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.&#xD;
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.&#xD;
Experimental App: Participant receives experimental app to test speed and error rate of communication.</description>
          </group>
        </group_list>
        <measure>
          <title>Speed of Communication</title>
          <description>Measure time (in minutes) to type 3 pre-set sentences</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Experimental App</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.13" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dynavox</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" spread="4.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Error Rate of Communication</title>
        <description>Amount of typing errors per sentence</description>
        <time_frame>At time of experiment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynavox Maestro and Experimental App</title>
            <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.&#xD;
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.&#xD;
Experimental App: Participant receives experimental app to test speed and error rate of communication.</description>
          </group>
        </group_list>
        <measure>
          <title>Error Rate of Communication</title>
          <description>Amount of typing errors per sentence</description>
          <units>errors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Experimental App</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dynavox</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Dynavox Maestro and Experimental App</title>
          <description>Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.&#xD;
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.&#xD;
Experimental App: Participant receives experimental app to test speed and error rate of communication.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Axel Krieger</name_or_title>
      <organization>Children's National</organization>
      <phone>2024761284</phone>
      <email>akrieger@childrensnational.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02242994
org study id: Pro00003767
nct id: NCT02242994
lead sponsor: 
The purpose of this study is to evaluate a touch screen application designed to help
      pediatric patients with cerebral palsy communicate. The study will test how well patients
      type on two different tools: one tool is already on the market , and the second tool is a
      newly developed App.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Speed of Communication
time frame: Immediately
description: Measure time (in minutes) to type 3 pre-set sentences
measure: Error Rate of Communication
time frame: At time of experiment
description: Amount of typing errors per sentence
arm group label: Dynavox Maestro and Experimental App
arm group type: Experimental
description: Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
intervention type: Device
intervention name: Dynavox Maestro
description: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
arm group label: Dynavox Maestro and Experimental App
intervention type: Device
intervention name: Experimental App
description: Participant receives experimental app to test speed and error rate of communication.
arm group label: Dynavox Maestro and Experimental App
criteria: 
gender: All
minimum age: 7 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's National Research Institute
investigator full name: Axel Krieger
investigator title: MD
mesh term: Cerebral Palsy
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 