<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/NCT03025776</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-FY2016-332</org_study_id>
    <nct_id>NCT03025776</nct_id>
  </id_info>
  <brief_title>One vs. Two Hand Use After Stroke: Role of Task Requirements</brief_title>
  <acronym>FSIFall2016</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>
      To further develop interventions, the investigators need a better understanding of which task&#xD;
      requirements (i.e. size or weight of object, location in workspace, etc.) drive a person&#xD;
      after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts&#xD;
      this relationship and compare this to reaching in age-matched healthy controls subjects. A&#xD;
      better understanding of this relationship will promote more informed development of&#xD;
      rehabilitative interventions. This study proposes to explore in people after stroke and&#xD;
      healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed&#xD;
      use, and ii.) how stroke severity impacts this arm use. We are proposing to study 15&#xD;
      individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour&#xD;
      session of task-related reaching in sitting and 33 age matched (double sample size) healthy&#xD;
      controls. The investigators will systematically vary task requirements (i.e. object size or&#xD;
      weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as&#xD;
      well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both&#xD;
      arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Hand Use (qualitative analysis of how many hands, which hand used) via video</measure>
    <time_frame>within 1st day session only (assessed w/i 2-3 hour session only)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>upper extremity kinematics (peak velocity, index of curvature, total movement time)</measure>
    <time_frame>within 2nd day session only (assessed w/i 2-3 hour session only)</time_frame>
    <description>measured on Day 2 session using electromagnetic sensors</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>stroke</arm_group_label>
    <description>individuals chronic (&gt; 6 months) post-stroke</description>
  </arm_group>
  <arm_group>
    <arm_group_label>age matched health controls</arm_group_label>
    <description>age matched (double sample size anticipated) healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reaching</intervention_name>
    <description>sitting reaching under various task conditions (size, speed, location)</description>
    <arm_group_label>age matched health controls</arm_group_label>
    <arm_group_label>stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kinematic collection while reaching</intervention_name>
    <description>sitting reaching under various task conditions (size, speed, location), told how many &amp; which hand to use, kinematic data collected</description>
    <arm_group_label>stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adults &gt; 18 years old chronic post-stroke with upper extremity paresis yet able to complete&#xD;
        a reach-to-grasp task independently with their paretic arm healthy controls &gt; 18 years old&#xD;
        (as per above)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        subjects post-stroke&#xD;
&#xD;
          -  passive flexibility (i.e. passive range of motion) in both arms such that the elbows&#xD;
             can be straightened within 15 degrees of normal and shoulders be flexed (lifted up) at&#xD;
             least 90 degrees and the hand needs to be able to open at least 75% of the way&#xD;
&#xD;
          -  Actively (of each subject's own accord/ability) they must be able to, without assist&#xD;
             in sitting and standing: straighten each elbow within 15 degrees of full range of&#xD;
             motion, lift each arm up at at least 60 degrees from at the side, open each hand from&#xD;
             a gross grasp volitionally.&#xD;
&#xD;
          -  able to lift a glass jar using 1 or 2 hands in sitting and standing 10&quot; above the&#xD;
             table top.&#xD;
&#xD;
          -  able to come to CSU for two x 3 hour visits with or without assistance of their&#xD;
             caregiver/significant other&#xD;
&#xD;
          -  No arm/hand injury within the last 3 months. * Individuals with common visual deficits&#xD;
             post-stroke (1 side partial visual field cut aka homonymous hemianopsia) will be&#xD;
             included.&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
        -age matched (double sample size); no known injury to arms within last 3 months, able to&#xD;
        carry out experimental task, no neurologic diagnoses/perceptual or sensory deficits&#xD;
        affecting arm movement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who have any additional/other neurologic condition (i.e. Parkinsons&#xD;
             Disease, multiple sclerosis, spinal cord injury)&#xD;
&#xD;
          -  severe perceptual neglect (tested using clock drawing test ).&#xD;
&#xD;
          -  Any individual who cannot answer phone screen questions competently and/or follow&#xD;
             simple 2 step commands during the in-person screen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cleveland State University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</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>
  <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/NCT03025776
org study id: IRB-FY2016-332
nct id: NCT03025776
lead sponsor: 
has dmc: No
To further develop interventions, the investigators need a better understanding of which task
      requirements (i.e. size or weight of object, location in workspace, etc.) drive a person
      after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts
      this relationship and compare this to reaching in age-matched healthy controls subjects. A
      better understanding of this relationship will promote more informed development of
      rehabilitative interventions. This study proposes to explore in people after stroke and
      healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed
      use, and ii.) how stroke severity impacts this arm use. We are proposing to study 15
      individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour
      session of task-related reaching in sitting and 33 age matched (double sample size) healthy
      controls. The investigators will systematically vary task requirements (i.e. object size or
      weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as
      well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both
      arms.
observational model: Cohort
time perspective: Prospective
measure: Hand Use (qualitative analysis of how many hands, which hand used) via video
time frame: within 1st day session only (assessed w/i 2-3 hour session only)
measure: upper extremity kinematics (peak velocity, index of curvature, total movement time)
time frame: within 2nd day session only (assessed w/i 2-3 hour session only)
description: measured on Day 2 session using electromagnetic sensors
arm group label: stroke
description: individuals chronic (> 6 months) post-stroke
arm group label: age matched health controls
description: age matched (double sample size anticipated) healthy controls
intervention type: Behavioral
intervention name: Reaching
description: sitting reaching under various task conditions (size, speed, location)
arm group label: age matched health controls
arm group label: stroke
intervention type: Behavioral
intervention name: Kinematic collection while reaching
description: sitting reaching under various task conditions (size, speed, location), told how many & which hand to use, kinematic data collected
arm group label: stroke
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cleveland State University
investigator full name: Maureen Whitford
investigator title: Assistant Professor
mesh term: Stroke