<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/NCT02190734</url>
  </required_header>
  <id_info>
    <org_study_id>Pusher1</org_study_id>
    <nct_id>NCT02190734</nct_id>
  </id_info>
  <brief_title>Pushing Behaviors in Individuals Post-stroke</brief_title>
  <official_title>Inpatient Rehabilitation Treatments and Effect on Pushing Behaviors in Individuals Post-stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this&#xD;
      study is to see if there are immediate changes in pushing behaviors in individuals who have&#xD;
      had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking&#xD;
      overground.&#xD;
&#xD;
      The investigators do not think there will be a change with sitting in the wheelchair, but the&#xD;
      investigators think there may be an improvement in pushing behaviors after walking training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population of interest is primarily individuals in inpatient rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burke Lateropulsion Scale</measure>
    <time_frame>Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period</time_frame>
    <description>Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>wheelchair, walking on treadmill, walking overground</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sitting in wheel chair Gait training on treadmill Gait training overground</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sitting in wheel chair</intervention_name>
    <description>Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes</description>
    <arm_group_label>wheelchair, walking on treadmill, walking overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait training on treadmill</intervention_name>
    <description>Walking on a treadmill with or without body weight support during 30 minute treatment</description>
    <arm_group_label>wheelchair, walking on treadmill, walking overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait training overground</intervention_name>
    <description>Walking overground with or without body weight support during 30 minute treatment</description>
    <arm_group_label>wheelchair, walking on treadmill, walking overground</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  score &gt;0 in each subsection of the Scale for Contraversive Pushing&#xD;
&#xD;
          -  admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting&#xD;
&#xD;
          -  stroke within previous 180 days&#xD;
&#xD;
          -  consent to participate in the study&#xD;
&#xD;
          -  ambulating greater than 150' at a time prior to stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other neurologic diagnoses&#xD;
&#xD;
          -  weight bearing precautions, orthopedic injuries, or other medical co-morbidities that&#xD;
             prevent adherence to the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>T. George Hornby, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Institute of Chicago, University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Hospital of the Pacific</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>May 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Thomas G Hornby</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Pusher Syndrome</keyword>
  <keyword>Lateropulsion</keyword>
  <keyword>Pushing Behaviors</keyword>
  <keyword>Burke Lateropulsion Scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02190734
org study id: Pusher1
nct id: NCT02190734
lead sponsor: 
has dmc: No
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this
      study is to see if there are immediate changes in pushing behaviors in individuals who have
      had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking
      overground.

      The investigators do not think there will be a change with sitting in the wheelchair, but the
      investigators think there may be an improvement in pushing behaviors after walking training.
The study population of interest is primarily individuals in inpatient rehabilitation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Burke Lateropulsion Scale
time frame: Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period
description: Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.
arm group label: wheelchair, walking on treadmill, walking overground
arm group type: Other
description: Sitting in wheel chair Gait training on treadmill Gait training overground
intervention type: Other
intervention name: Sitting in wheel chair
description: Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes
arm group label: wheelchair, walking on treadmill, walking overground
intervention type: Other
intervention name: Gait training on treadmill
description: Walking on a treadmill with or without body weight support during 30 minute treatment
arm group label: wheelchair, walking on treadmill, walking overground
intervention type: Other
intervention name: Gait training overground
description: Walking overground with or without body weight support during 30 minute treatment
arm group label: wheelchair, walking on treadmill, walking overground
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: T. George Hornby, PT, PhD
role: Principal Investigator
affiliation: Rehabilitation Institute of Chicago, University of Illinois at Chicago
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Thomas G Hornby
investigator title: Principal Investigator
mesh term: Stroke