<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/NCT01684254</url>
  </required_header>
  <id_info>
    <org_study_id>2007-P-000837</org_study_id>
    <nct_id>NCT01684254</nct_id>
  </id_info>
  <brief_title>An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy</brief_title>
  <official_title>An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peabody Foundation, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <brief_summary>
    <textblock>
      The present project will focus on evaluating the technical efficacy of the in-shoe gait&#xD;
      monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of&#xD;
      children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators on this protocol intend to develop the device and rely on it to propose a&#xD;
      Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of&#xD;
      toe walking over time and for assessing the outcome of surgical and non-surgical&#xD;
      interventions.&#xD;
&#xD;
      Tasks include:&#xD;
&#xD;
      A.Validate data acquisition measurements in laboratory setting compared to gold-standard&#xD;
      video analysis and field (outside of laboratory).&#xD;
&#xD;
      B.Develop multi-stage classification algorithm from subset of laboratory and field data.&#xD;
&#xD;
      C.Validate classification algorithm against random subsets of laboratory and field data.&#xD;
&#xD;
      D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical&#xD;
      and ActiveGait data for different ambulatory conditions.&#xD;
&#xD;
      E.Perform longitudinal study of the childhood toe walking population including both&#xD;
      laboratory analysis and at-home monitoring using ActiveGait technology.&#xD;
&#xD;
      F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical&#xD;
      observations. Gather evidence that the TWS index provides a means to track changes in&#xD;
      severity of toe walking over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Toe Walking Severity (TWS) index</measure>
    <time_frame>1 day</time_frame>
    <description>Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Visual Scale (EVS) score</measure>
    <time_frame>1 day</time_frame>
    <description>Clinical measure of severity of gait deviation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Children With Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Children with Cerebral Palsy (CP)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children diagnosed with CP&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to ambulate 50 feet on level ground without the assistance of a person&#xD;
&#xD;
          -  able to ambulate on ramps and stairs without the assistance of a person&#xD;
&#xD;
          -  demonstrate a toe-walking pattern at the time of enrollment&#xD;
&#xD;
          -  medically stable&#xD;
&#xD;
          -  able to understand directions and follow simple instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any cardiopulmonary, orthopedic, and neurological conditions other than CP that would&#xD;
             prevent them from performing the motor tasks of interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spaulding Rehabilitation Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>March 9, 2017</last_update_submitted>
  <last_update_submitted_qc>March 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Paolo Bonato</investigator_full_name>
    <investigator_title>Director, Motion Analysis Laboratory</investigator_title>
  </responsible_party>
  <keyword>Cerebral Palsy</keyword>
  <keyword>Home monitoring</keyword>
  <keyword>Gait</keyword>
  <keyword>Sensorized Shoe</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>
  <!-- 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/NCT01684254
org study id: 2007-P-000837
nct id: NCT01684254
lead sponsor: 
collaborator: 
The present project will focus on evaluating the technical efficacy of the in-shoe gait
      monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of
      children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.
The investigators on this protocol intend to develop the device and rely on it to propose a
      Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of
      toe walking over time and for assessing the outcome of surgical and non-surgical
      interventions.

      Tasks include:

      A.Validate data acquisition measurements in laboratory setting compared to gold-standard
      video analysis and field (outside of laboratory).

      B.Develop multi-stage classification algorithm from subset of laboratory and field data.

      C.Validate classification algorithm against random subsets of laboratory and field data.

      D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical
      and ActiveGait data for different ambulatory conditions.

      E.Perform longitudinal study of the childhood toe walking population including both
      laboratory analysis and at-home monitoring using ActiveGait technology.

      F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical
      observations. Gather evidence that the TWS index provides a means to track changes in
      severity of toe walking over time.
observational model: Cohort
time perspective: Cross-Sectional
measure: Toe Walking Severity (TWS) index
time frame: 1 day
description: Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole
measure: Edinburgh Visual Scale (EVS) score
time frame: 1 day
description: Clinical measure of severity of gait deviation
arm group label: Children with Cerebral Palsy (CP)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Paolo Bonato
investigator title: Director, Motion Analysis Laboratory
mesh term: Paralysis
mesh term: Cerebral Palsy