<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/NCT02246751</url>
  </required_header>
  <id_info>
    <org_study_id>CP_TT_2014</org_study_id>
    <nct_id>NCT02246751</nct_id>
  </id_info>
  <brief_title>Case Series_Targeted Training for Trunk Control Cerebral Palsy</brief_title>
  <acronym>CP_TT_UHart</acronym>
  <official_title>Effect of Targeted Training on Sensorimotor Control of Trunk Posture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hartford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hartford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known about how children with cerebral palsy (CP) use their sensory systems (touch,&#xD;
      sense of body position, balance organs in the inner ear, vision) to help them achieve trunk&#xD;
      control for independent sitting. If a child with CP does not achieve trunk control by 4 years&#xD;
      of age their prognosis for motor skill development including walking is poor. Clinical&#xD;
      researchers at The Movement Centre in Oswestry, England have developed a method called&#xD;
      Targeted Training in which children train trunk control in small segments from the top down&#xD;
      using a custom fit training device. This study aims to examine how children with moderate to&#xD;
      severe CP use sensory information for trunk control before, during and after a program of&#xD;
      Targeted Training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the major challenges of motor control is to understand how the central nervous system&#xD;
      controls the degrees of freedom of the body. This is particularly evident in cerebral palsy&#xD;
      (CP), which is the most prevalent chronic childhood motor disability and is one of the most&#xD;
      disabling and costly chronic disorders of children and adults. Deficits in postural control&#xD;
      and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for&#xD;
      independent sitting creates the foundation for all other motor tasks, surprisingly little is&#xD;
      known about how children with CP use sensory input to guide their development of upright&#xD;
      control (which occurs in typically developing infants by 8 months of age). This lack of&#xD;
      knowledge limits our ability to effectively assess and treat children with neuromotor&#xD;
      deficits in trunk control.&#xD;
&#xD;
      The objectives of this project are to identify sensory reliance and sensory re-weighting in a&#xD;
      study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted&#xD;
      Training for Trunk Control. A novel trunk support device will enable testing of participants&#xD;
      who lack (or are still developing) stable sitting. In experiments, kinematics of the head and&#xD;
      trunk will be measured. Sensory reliance and re-weighting will be identified from postural&#xD;
      trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or&#xD;
      tilts of a surface which participants sit upon. Generally, participants with a high reliance&#xD;
      on vestibular feedback will remain upright with respect to gravity during all tests; whereas&#xD;
      a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and&#xD;
      toward the surface or visual surround tilt, respectively. To tease apart biomechanical,&#xD;
      physical, and neurological contributions to trunk sway, sensorimotor integration modeling&#xD;
      will be used to complement data interpretation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sensory motor processes</measure>
    <time_frame>9 months and 1 and 3 months post training</time_frame>
    <description>Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gross motor functional skills (e.g. sitting, crawling, standing)</measure>
    <time_frame>9 months and 1 &amp; 3 months post training</time_frame>
    <description>The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Segmental Assessment of Trunk Control</measure>
    <time_frame>2, 4, 6, 8 and 9 months and 1 &amp; 3 months post training</time_frame>
    <description>Change in the trunk segment where static, active or reactive control is lost.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participation and Environment Measure for Children and Youth (CY) or Young Children (YC) (PEM-CY for children 5-12 years of age, or YC-PEM for children 2-5 years)</measure>
    <time_frame>9 months and 3 months post training</time_frame>
    <description>The PEM-CY and YC-PEM are parent response questionnaires that measure participation frequency, extent of involvement and desire for change in sets of activities typical for the home, school or community.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Single subject design case series</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Targeted Training for trunk control</intervention_name>
    <description>Orthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control.</description>
    <arm_group_label>Single subject design case series</arm_group_label>
    <other_name>Segmental training for trunk control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cerebral palsy&#xD;
&#xD;
          -  age 2-12 years&#xD;
&#xD;
          -  Gross Motor Function Classification System (GMFCS) Level III, IV or V&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spinal fixation&#xD;
&#xD;
          -  fixed scoliosis&#xD;
&#xD;
          -  uncontrolled seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Saavedra, MS, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hartford</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adam Goodworth, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hartford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Balance Laboratory; University of Hartford;</name>
      <address>
        <city>West Hartford</city>
        <state>Connecticut</state>
        <zip>06117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21. Erratum In: J Neurophysiol. 2012 Oct;108(8):2338.</citation>
    <PMID>21940611</PMID>
  </reference>
  <reference>
    <citation>Goodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.</citation>
    <PMID>19403751</PMID>
  </reference>
  <reference>
    <citation>Saavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.</citation>
    <PMID>22832568</PMID>
  </reference>
  <reference>
    <citation>Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.</citation>
    <PMID>20699770</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>September 4, 2020</last_update_submitted>
  <last_update_submitted_qc>September 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postural control</keyword>
  <keyword>Targeted Training</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>sensorimotor control</keyword>
  <keyword>trunk segments</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</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/NCT02246751
org study id: CP_TT_2014
nct id: NCT02246751
lead sponsor: 
has dmc: No
Little is known about how children with cerebral palsy (CP) use their sensory systems (touch,
      sense of body position, balance organs in the inner ear, vision) to help them achieve trunk
      control for independent sitting. If a child with CP does not achieve trunk control by 4 years
      of age their prognosis for motor skill development including walking is poor. Clinical
      researchers at The Movement Centre in Oswestry, England have developed a method called
      Targeted Training in which children train trunk control in small segments from the top down
      using a custom fit training device. This study aims to examine how children with moderate to
      severe CP use sensory information for trunk control before, during and after a program of
      Targeted Training.
One of the major challenges of motor control is to understand how the central nervous system
      controls the degrees of freedom of the body. This is particularly evident in cerebral palsy
      (CP), which is the most prevalent chronic childhood motor disability and is one of the most
      disabling and costly chronic disorders of children and adults. Deficits in postural control
      and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for
      independent sitting creates the foundation for all other motor tasks, surprisingly little is
      known about how children with CP use sensory input to guide their development of upright
      control (which occurs in typically developing infants by 8 months of age). This lack of
      knowledge limits our ability to effectively assess and treat children with neuromotor
      deficits in trunk control.

      The objectives of this project are to identify sensory reliance and sensory re-weighting in a
      study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted
      Training for Trunk Control. A novel trunk support device will enable testing of participants
      who lack (or are still developing) stable sitting. In experiments, kinematics of the head and
      trunk will be measured. Sensory reliance and re-weighting will be identified from postural
      trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or
      tilts of a surface which participants sit upon. Generally, participants with a high reliance
      on vestibular feedback will remain upright with respect to gravity during all tests; whereas
      a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and
      toward the surface or visual surround tilt, respectively. To tease apart biomechanical,
      physical, and neurological contributions to trunk sway, sensorimotor integration modeling
      will be used to complement data interpretation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in sensory motor processes
time frame: 9 months and 1 and 3 months post training
description: Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
measure: Change in gross motor functional skills (e.g. sitting, crawling, standing)
time frame: 9 months and 1 & 3 months post training
description: The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy
measure: Segmental Assessment of Trunk Control
time frame: 2, 4, 6, 8 and 9 months and 1 & 3 months post training
description: Change in the trunk segment where static, active or reactive control is lost.
measure: Participation and Environment Measure for Children and Youth (CY) or Young Children (YC) (PEM-CY for children 5-12 years of age, or YC-PEM for children 2-5 years)
time frame: 9 months and 3 months post training
description: The PEM-CY and YC-PEM are parent response questionnaires that measure participation frequency, extent of involvement and desire for change in sets of activities typical for the home, school or community.
arm group label: Single subject design case series
arm group type: Experimental
description: Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.
intervention type: Device
intervention name: Targeted Training for trunk control
description: Orthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control.
arm group label: Single subject design case series
other name: Segmental training for trunk control
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Sandra Saavedra, MS, PT, PhD
role: Principal Investigator
affiliation: University of Hartford
last name: Adam Goodworth, MS, PhD
role: Principal Investigator
affiliation: University of Hartford
facility: 
country: United States
citation: Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21. Erratum In: J Neurophysiol. 2012 Oct;108(8):2338.
PMID: 21940611
citation: Goodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.
PMID: 19403751
citation: Saavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.
PMID: 22832568
citation: Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
PMID: 20699770
responsible party type: Sponsor
mesh term: Cerebral Palsy
sharing ipd: No