<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/NCT04436042</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS8104</org_study_id>
    <secondary_id>R01NS115652</secondary_id>
    <nct_id>NCT04436042</nct_id>
  </id_info>
  <brief_title>MyHand 2: An Active Hand Orthosis for Stroke Patients</brief_title>
  <acronym>MyHand 2</acronym>
  <official_title>MyHand 2: An Active Hand Orthosis for Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to further develop and test the hardware and software components of&#xD;
      the MyHand device based on user feedback and results from our pilot study. The goal is to&#xD;
      refine the device so that is more effective and easier for stroke patients to use to increase&#xD;
      their hand function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From previous experimentation with the MyHand device, the investigators have determined that&#xD;
      the device can improve the grasping ability of stroke patients. The investigators now aim to&#xD;
      make the controls more intuitive and accurate for the users, to enable subjects to grasp a&#xD;
      wider array of objects, to make the donning and doffing of the device easier, and to continue&#xD;
      to assess the MyHand as it helps subjects in functional tasks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Usability and Utility Questionnaire Score</measure>
    <time_frame>Up to 1 year at study completion</time_frame>
    <description>Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree.&#xD;
The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparesis</condition>
  <arm_group>
    <arm_group_label>MyHand Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use the MyHand device during repetitive grasp and release tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MyHand Device</intervention_name>
    <description>These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.</description>
    <arm_group_label>MyHand Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years old&#xD;
&#xD;
          -  History of stroke(s) with most recent stroke at least six months ago&#xD;
&#xD;
          -  Upper extremity weakness with impaired ability to complete daily activities with&#xD;
             affected hand&#xD;
&#xD;
          -  Full passive range of motion in all digits&#xD;
&#xD;
          -  Intact cognition to follow directions&#xD;
&#xD;
          -  Gross control of proximal upper extremity musculature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other neurological conditions besides stroke&#xD;
&#xD;
          -  Other orthopedic conditions to affected upper extremity&#xD;
&#xD;
          -  Significant spasticity in affected upper extremity that impairs device fit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Stein</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Winterbottom, MS</last_name>
    <phone>212-305-6722</phone>
    <email>lbw2136@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joel Stein, MD</last_name>
    <phone>212-305-4818</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Winterbottom, MS</last_name>
      <phone>212-305-6722</phone>
      <email>lbw2136@cumc.columbia.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Joel Stein, MD</investigator_full_name>
    <investigator_title>Professor and Chair of the Department of Rehabilitation and Regenerative Medicine</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Hemiparesis</keyword>
  <keyword>Robotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</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/NCT04436042
org study id: AAAS8104
secondary id: R01NS115652
nct id: NCT04436042
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study is designed to further develop and test the hardware and software components of
      the MyHand device based on user feedback and results from our pilot study. The goal is to
      refine the device so that is more effective and easier for stroke patients to use to increase
      their hand function.
From previous experimentation with the MyHand device, the investigators have determined that
      the device can improve the grasping ability of stroke patients. The investigators now aim to
      make the controls more intuitive and accurate for the users, to enable subjects to grasp a
      wider array of objects, to make the donning and doffing of the device easier, and to continue
      to assess the MyHand as it helps subjects in functional tasks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Device Usability and Utility Questionnaire Score
time frame: Up to 1 year at study completion
description: Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree.
The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.
arm group label: MyHand Treatment
arm group type: Experimental
description: Participants will use the MyHand device during repetitive grasp and release tasks.
intervention type: Device
intervention name: MyHand Device
description: These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
arm group label: MyHand Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel Stein
role: Principal Investigator
affiliation: Columbia University
last name: Lauren Winterbottom, MS
phone: 212-305-6722
email: lbw2136@cumc.columbia.edu
last name: Joel Stein, MD
phone: 212-305-4818
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Joel Stein, MD
investigator title: Professor and Chair of the Department of Rehabilitation and Regenerative Medicine
mesh term: Stroke
mesh term: Paresis
sharing ipd: No