<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/NCT02995213</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-FY2016-84</org_study_id>
    <nct_id>NCT02995213</nct_id>
  </id_info>
  <brief_title>Quantification of UE Use and Effects of Feedback in the Home Setting</brief_title>
  <acronym>OPTASpr2016</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Cleveland State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cleveland State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are proposing a pilot study, the purpose of which is to use accelerometers&#xD;
      to quantify UE use (1 and two hand use) in people post-stroke from which the investigators&#xD;
      will develop use-based feedback to improve recovery in the home setting. The objectives of&#xD;
      this pilot study are to:&#xD;
&#xD;
      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the&#xD;
      home setting in individuals chronic post-stroke,&#xD;
&#xD;
      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger&#xD;
      (non-paretic) UEs, and&#xD;
&#xD;
      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on&#xD;
      unilateral and bilateral UE use.&#xD;
&#xD;
      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally&#xD;
      in subjects post-chronic stroke pre and post feedback.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Accelerometer based paretic arm amount of use</measure>
    <time_frame>3 week period</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Feedback Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Accelerometer based feedback about paretic arm use</intervention_name>
    <arm_group_label>Feedback Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects post-stroke&#xD;
&#xD;
          -  chronic post ischemic or hemorrhagic cortical or subcortical stroke&#xD;
&#xD;
          -  25 - 100 years old&#xD;
&#xD;
          -  upper extremity impairment&#xD;
&#xD;
          -  Subjects will need to be able to flex their paretic shoulder and their elbow &gt; 40°&#xD;
             without assist&#xD;
&#xD;
          -  able to follow 2-step commands&#xD;
&#xD;
          -  community dwelling with or without assistance&#xD;
&#xD;
          -  intact superficial light touch sensation in both upper extremities&#xD;
&#xD;
          -  must also have some movement in both arms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  can't currently have another neuromuscular disorders such as spinal cord injury,&#xD;
             traumatic brain injury, Parkinson disease or multiple sclerosis&#xD;
&#xD;
          -  no upper extremity injury within the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cleveland State University</investigator_affiliation>
    <investigator_full_name>Maureen Whitford</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT02995213
org study id: IRB-FY2016-84
nct id: NCT02995213
lead sponsor: 
has dmc: No
The investigators are proposing a pilot study, the purpose of which is to use accelerometers
      to quantify UE use (1 and two hand use) in people post-stroke from which the investigators
      will develop use-based feedback to improve recovery in the home setting. The objectives of
      this pilot study are to:

      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the
      home setting in individuals chronic post-stroke,

      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger
      (non-paretic) UEs, and

      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on
      unilateral and bilateral UE use.

      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally
      in subjects post-chronic stroke pre and post feedback.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Accelerometer based paretic arm amount of use
time frame: 3 week period
arm group label: Feedback Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: Accelerometer based feedback about paretic arm use
arm group label: Feedback Intervention
criteria: 
gender: All
minimum age: 25 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cleveland State University
investigator full name: Maureen Whitford
investigator title: Assistant Professor
sharing ipd: No