<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/NCT02995200</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-FY2016-182</org_study_id>
    <nct_id>NCT02995200</nct_id>
  </id_info>
  <brief_title>Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting</brief_title>
  <acronym>UnSumRes2015</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>
      A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two&#xD;
      hand use) in healthy controls and people post-stroke from which the investigators will&#xD;
      develop use-based feedback to improve recovery in the home setting. The objectives of this&#xD;
      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 healthy individuals and individuals chronic post-stroke,&#xD;
&#xD;
      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger&#xD;
      (non-paretic) UEs,&#xD;
&#xD;
      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic&#xD;
      post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and&#xD;
&#xD;
      iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on&#xD;
      unilateral and bilateral UE use.&#xD;
&#xD;
      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between&#xD;
      healthy controls and subjects post-chronic stroke pre and post feedback (for the people after&#xD;
      stroke).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of Use (measured by accelerometer)</measure>
    <time_frame>3 week period</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Feedback Intervention (Participants Post-stroke)</condition>
  <condition>Healthy Control</condition>
  <arm_group>
    <arm_group_label>Group Post-Stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 sessions of in-home accelerometer based feedback about paretic arm use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Accelerometer Based Feedback</intervention_name>
    <arm_group_label>Group Post-Stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with&#xD;
             experimental protocol, living in a home setting, full active range of motion (AROM) in&#xD;
             both shoulders and elbows for their age group.&#xD;
&#xD;
          -  Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community&#xD;
             dwelling with or without assistance, no upper extremity (UE) injury within the last 3&#xD;
             months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in&#xD;
             shoulder and elbow in or out of synergy, intact superficial light touch sensation in&#xD;
             both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either&#xD;
             cortical, subcortical or in the cerebellum. It does not need to be their first and&#xD;
             only stroke.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy Adults: Injury of either UE within the last 3 months and unable to follow&#xD;
             commands related to the accelerometer use/protocol.&#xD;
&#xD;
          -  Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to&#xD;
             study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's&#xD;
             Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the&#xD;
             MoCA and Stroke Impact Scale (SIS) questions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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/NCT02995200
org study id: IRB-FY2016-182
nct id: NCT02995200
lead sponsor: 
has dmc: No
A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two
      hand use) in healthy controls and 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 healthy individuals and individuals chronic post-stroke,

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

      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic
      post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and

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

      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between
      healthy controls and subjects post-chronic stroke pre and post feedback (for the people after
      stroke).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amount of Use (measured by accelerometer)
time frame: 3 week period
arm group label: Group Post-Stroke
arm group type: Experimental
description: 2 sessions of in-home accelerometer based feedback about paretic arm use
arm group label: Healthy Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Accelerometer Based Feedback
arm group label: Group Post-Stroke
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cleveland State University
investigator full name: Maureen Whitford
investigator title: Assistant Professor
sharing ipd: No