<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/NCT03808233</url>
  </required_header>
  <id_info>
    <org_study_id>STU 052016-109</org_study_id>
    <nct_id>NCT03808233</nct_id>
  </id_info>
  <brief_title>Reliability and Validity of the ACTIVE-mini for Quantifying Movement in Infants With Spinal Muscular Atrophy</brief_title>
  <official_title>Reliability and Validity of the ACTIVE-mini for Quantifying Movement in Infants With Spinal Muscular Atrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the measurement properties of the Ability&#xD;
      Captured Through Interactive Video Evaluation-mini (ACTIVE-mini) for quantifying movement in&#xD;
      infants with Spinal Muscular Atrophy (SMA). Specifically, I will investigate within-day and&#xD;
      between-day test-retest reliability and calculate the minimal detectable change of the&#xD;
      ACTIVE-mini. Additionally, I will determine the concurrent validity of the ACTIVE-mini with&#xD;
      The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND)&#xD;
      and the construct validity of the ACTIVE-mini in infants with SMA using a known group&#xD;
      methodology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a cross-sectional, repeated measure design, investigating the test-retest&#xD;
      within- and between-day reliability and the convergent construct validity and the&#xD;
      known-groups method construct validity of the ACTIVE-mini. The group variable included two&#xD;
      levels (non-rolling infants with SMA and function matched non-rolling typically developing&#xD;
      infants). The dependent variables included a predicted CHOP INTEND score determined by data&#xD;
      captured by the ACTIVE-mini and the CHOP INTEND extremity score. The dependent variables were&#xD;
      collected at two time points over two days at a minimum of 24 hours and no more than 30 days&#xD;
      between collections. Variables were collected in a standard order of assessment. All&#xD;
      participants underwent all assessments as set out in the procedures. Based on results from&#xD;
      pilot data, the conclusion was made that the ACTIVE-mini could quantify infant movement&#xD;
      parameters well enough to warrant further investigation. These data were important in&#xD;
      establishing the feasibility of the specific aims of this research, because they provide&#xD;
      initial validation of the ability of ACTIVE-mini to quantify basic infant movement parameters&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ACTIVE mini</measure>
    <time_frame>2 minutes</time_frame>
    <description>the ACTIVE-mini, is a physiological parameter non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Spinal Muscular Atrophy</condition>
  <arm_group>
    <arm_group_label>Spinal Muscular Atrophy Type 1</arm_group_label>
    <description>Non rolling infants or children with SMA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Rolling Function matched control</arm_group_label>
    <description>Non rolling typically developing infant</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ACTIVE mini</intervention_name>
    <description>the ACTIVE-mini, is a non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.</description>
    <arm_group_label>Non Rolling Function matched control</arm_group_label>
    <arm_group_label>Spinal Muscular Atrophy Type 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        SMA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Participants will be included in this study if they:&#xD;
&#xD;
          -  are non-rolling at time of enrollment&#xD;
&#xD;
          -  age birth to 25 months&#xD;
&#xD;
          -  have no concomitant system pathology that would limit clinical evaluation.&#xD;
&#xD;
        These inclusion criteria are set for both affected babies and healthy controls.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded from this study if they:&#xD;
&#xD;
          -  demonstrate evidence of renal dysfunction, central nervous system damage,&#xD;
             neuro-degenerative or neuromuscular disease other than SMA type I or II;&#xD;
&#xD;
          -  require mechanical ventilation of any type &gt; 16 hours per day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>June 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Muscular Atrophy, Spinal</mesh_term>
    <mesh_term>Atrophy</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/NCT03808233
org study id: STU 052016-109
nct id: NCT03808233
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the measurement properties of the Ability
      Captured Through Interactive Video Evaluation-mini (ACTIVE-mini) for quantifying movement in
      infants with Spinal Muscular Atrophy (SMA). Specifically, I will investigate within-day and
      between-day test-retest reliability and calculate the minimal detectable change of the
      ACTIVE-mini. Additionally, I will determine the concurrent validity of the ACTIVE-mini with
      The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND)
      and the construct validity of the ACTIVE-mini in infants with SMA using a known group
      methodology.
This study was a cross-sectional, repeated measure design, investigating the test-retest
      within- and between-day reliability and the convergent construct validity and the
      known-groups method construct validity of the ACTIVE-mini. The group variable included two
      levels (non-rolling infants with SMA and function matched non-rolling typically developing
      infants). The dependent variables included a predicted CHOP INTEND score determined by data
      captured by the ACTIVE-mini and the CHOP INTEND extremity score. The dependent variables were
      collected at two time points over two days at a minimum of 24 hours and no more than 30 days
      between collections. Variables were collected in a standard order of assessment. All
      participants underwent all assessments as set out in the procedures. Based on results from
      pilot data, the conclusion was made that the ACTIVE-mini could quantify infant movement
      parameters well enough to warrant further investigation. These data were important in
      establishing the feasibility of the specific aims of this research, because they provide
      initial validation of the ability of ACTIVE-mini to quantify basic infant movement parameters
observational model: Cohort
time perspective: Prospective
measure: ACTIVE mini
time frame: 2 minutes
description: the ACTIVE-mini, is a physiological parameter non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.
arm group label: Spinal Muscular Atrophy Type 1
description: Non rolling infants or children with SMA
arm group label: Non Rolling Function matched control
description: Non rolling typically developing infant
intervention type: Other
intervention name: ACTIVE mini
description: the ACTIVE-mini, is a non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.
arm group label: Non Rolling Function matched control
arm group label: Spinal Muscular Atrophy Type 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Sponsor
mesh term: Muscular Atrophy
mesh term: Muscular Atrophy, Spinal
mesh term: Atrophy
sharing ipd: No