<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/NCT03770832</url>
  </required_header>
  <id_info>
    <org_study_id>SX04202018</org_study_id>
    <nct_id>NCT03770832</nct_id>
  </id_info>
  <brief_title>Wearable Sensors and Video Recordings to Monitor Motor Development</brief_title>
  <official_title>Wearable Sensors and Video Recording for Children (Birth to 24 Months) to Monitor Motor Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shirley Ryan AbilityLab</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>
      The objective of this study is to develop an automated, precise, quantitative assay for&#xD;
      detecting atypical motor behavior and development in infants using data from wearable sensors&#xD;
      and video recordings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Three month clinical score estimation</measure>
    <time_frame>3 months</time_frame>
    <description>Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six month clinical score estimation</measure>
    <time_frame>6 months</time_frame>
    <description>Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prediction of neuromotor outcome using sensor and video data from 3 month time-point</measure>
    <time_frame>3 months</time_frame>
    <description>Sensitivity and specificity of algorithm (trained on sensor and video data from the 3 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prediction of neuromotor outcome using sensor and video data from 6 month time-point</measure>
    <time_frame>6 months</time_frame>
    <description>Sensitivity and specificity of algorithm (trained on sensor and video data from the 6 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prediction of neuromotor outcome using General Movements Assessment (GMA) scores</measure>
    <time_frame>1-2 weeks, 1 month, 3 months</time_frame>
    <description>Sensitivity and specificity of GMA scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The GMA is an observational exam where an infant's spontaneous movements are scored as atypical or normal for their age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores</measure>
    <time_frame>6 months, 9 months, 1 year</time_frame>
    <description>Sensitivity and specificity of AIMS scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The AIMS is a norm-referenced observational assessment with a minimum score of 0 and a maximum score of 58. Higher scores indicate better motor performance on the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores</measure>
    <time_frame>6 months, 9 months, 1 year</time_frame>
    <description>Sensitivity and specificity of HINE scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The HINE is a neurological exam with a minimum score of 0 and a maximum score of 78. Higher scores indicate better performance on the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores</measure>
    <time_frame>1-2 weeks, 1 month, 3 months</time_frame>
    <description>Sensitivity and specificity of TIMP scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical score estimation</measure>
    <time_frame>1-2 weeks, 1 month, 9 months, 1 year, 2 years</time_frame>
    <description>Error between true clinical test scores and scores estimated from sensor and video data, assessed at each remaining time-point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points</measure>
    <time_frame>1-2 weeks, 1 month, 9 months, 1 year, 2 years</time_frame>
    <description>Sensitivity and specificity of algorithm (trained on sensor and video data from the remaining time-points) to predict neuromotor outcome at 2 years (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prediction of neuromotor outcome using NICU Network Neurobehavioral Scale (NNNS) scores</measure>
    <time_frame>1 month</time_frame>
    <description>Sensitivity and specificity of NNNS scores (taken at 1 month) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Motor Delay</condition>
  <condition>Neurodevelopmental Disorders</condition>
  <condition>Developmental Disability</condition>
  <arm_group>
    <arm_group_label>Infants at Risk for Atypical Motor Development (high-risk)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants Expected to Have Typical Motor Development (low-risk)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals at high risk of developing motor delays &lt;24 months of age along with infants at&#xD;
        low risk of developing motor delays.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals identified as potentially at risk of abnormal motor development due to a&#xD;
             risk factor (for example, prematurity, neonatal hypoxic ischemic encephalopathy, or&#xD;
             neonatal stroke) OR control individuals for whom normal motor development is expected.&#xD;
&#xD;
          -  Age: &lt; 24 months of age&#xD;
&#xD;
          -  Legal guardian able and willing to give written consent and comply with study&#xD;
             procedures.&#xD;
&#xD;
          -  In case of multiple pregnancies, only one child selected at random will participate in&#xD;
             the research activities. Study staff will have no influence over the selection,&#xD;
             besides any known medical condition automatically excluding the baby as listed in our&#xD;
             exclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any open wound or skin breakdown on the limbs or upper torso.&#xD;
&#xD;
          -  Missing or incomplete limbs (such as from amputation or congenital limb defects)&#xD;
&#xD;
          -  Legal guardian unable to give written consent and comply with study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arun Jayaraman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Megan O'Brien, PhD</last_name>
    <phone>312-238-2289</phone>
    <email>mobrien02@sralab.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Andersen</last_name>
    <phone>312-238-1476</phone>
    <email>randersen@sralab.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shirley Ryan AbilityLab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Arun Jayaraman, PT, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Early Detection</keyword>
  <keyword>Wearable Sensors</keyword>
  <keyword>Computer Vision</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
    <mesh_term>Developmental Disabilities</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/NCT03770832
org study id: SX04202018
nct id: NCT03770832
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to develop an automated, precise, quantitative assay for
      detecting atypical motor behavior and development in infants using data from wearable sensors
      and video recordings.
observational model: Cohort
time perspective: Prospective
measure: Three month clinical score estimation
time frame: 3 months
description: Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.
measure: Six month clinical score estimation
time frame: 6 months
description: Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.
measure: Prediction of neuromotor outcome using sensor and video data from 3 month time-point
time frame: 3 months
description: Sensitivity and specificity of algorithm (trained on sensor and video data from the 3 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])
measure: Prediction of neuromotor outcome using sensor and video data from 6 month time-point
time frame: 6 months
description: Sensitivity and specificity of algorithm (trained on sensor and video data from the 6 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])
measure: Prediction of neuromotor outcome using General Movements Assessment (GMA) scores
time frame: 1-2 weeks, 1 month, 3 months
description: Sensitivity and specificity of GMA scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The GMA is an observational exam where an infant's spontaneous movements are scored as atypical or normal for their age.
measure: Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores
time frame: 6 months, 9 months, 1 year
description: Sensitivity and specificity of AIMS scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The AIMS is a norm-referenced observational assessment with a minimum score of 0 and a maximum score of 58. Higher scores indicate better motor performance on the assessment.
measure: Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores
time frame: 6 months, 9 months, 1 year
description: Sensitivity and specificity of HINE scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The HINE is a neurological exam with a minimum score of 0 and a maximum score of 78. Higher scores indicate better performance on the assessment.
measure: Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores
time frame: 1-2 weeks, 1 month, 3 months
description: Sensitivity and specificity of TIMP scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]).
measure: Clinical score estimation
time frame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
description: Error between true clinical test scores and scores estimated from sensor and video data, assessed at each remaining time-point.
measure: Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points
time frame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
description: Sensitivity and specificity of algorithm (trained on sensor and video data from the remaining time-points) to predict neuromotor outcome at 2 years (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])
measure: Prediction of neuromotor outcome using NICU Network Neurobehavioral Scale (NNNS) scores
time frame: 1 month
description: Sensitivity and specificity of NNNS scores (taken at 1 month) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])
arm group label: Infants at Risk for Atypical Motor Development (high-risk)
arm group label: Infants Expected to Have Typical Motor Development (low-risk)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Months
maximum age: 24 Months
healthy volunteers: No
last name: Arun Jayaraman, PT, PhD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
last name: Megan O'Brien, PhD
phone: 312-238-2289
email: mobrien02@sralab.org
last name: Rachel Andersen
phone: 312-238-1476
email: randersen@sralab.org
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Arun Jayaraman, PT, PhD
investigator title: Principal Investigator
mesh term: Neurodevelopmental Disorders
mesh term: Developmental Disabilities