<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/NCT03263286</url>
  </required_header>
  <id_info>
    <org_study_id>2016-064</org_study_id>
    <nct_id>NCT03263286</nct_id>
  </id_info>
  <brief_title>Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton</brief_title>
  <acronym>HandSOME</acronym>
  <official_title>Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of America</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MedStar National Rehabilitation Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of America</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke&#xD;
      victims regain functional use of their hand and regain independent living. Participants will&#xD;
      use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes&#xD;
      from the intervention after the 8 weeks and also at a 3 month followup.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After stroke, individuals often have great difficulty with using the affected hand in&#xD;
      functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger&#xD;
      extensor weakness. This leads to increased difficulty in grasp and release of objects.&#xD;
      HandSOME is a light weight wearable hand orthosis that increases range of motion and&#xD;
      decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME&#xD;
      device's effectiveness in the rehabilitation of stroke patients through an 8 week&#xD;
      intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit&#xD;
      per week to the clinic to evaluate progress and troubleshoot problems with the device. The&#xD;
      hypotheses are that the gains from the 8 weeks of training will be statistically significant&#xD;
      and clinically important (defined as gains of greater than 10% of full scale) in the domains&#xD;
      of impairment, function and amount of arm use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2017</start_date>
  <completion_date type="Actual">October 7, 2019</completion_date>
  <primary_completion_date type="Actual">October 7, 2019</primary_completion_date>
  <phase>Phase 1</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>Change in Fugl-Meyer Test of Arm Function</measure>
    <time_frame>Change from baseline Fugl-Meyer score at 2 months</time_frame>
    <description>clinical test of arm motor ability and impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Action Research Arm Test</measure>
    <time_frame>Change from baseline Action Research Arm Test score at 2 months</time_frame>
    <description>clinical test of the functional limitations of the upper extremities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Motor Activity Log</measure>
    <time_frame>Change from baseline Motor Activity Log score at 2 months</time_frame>
    <description>assess the amount and quality of limb use at home</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fugl-Meyer Test of Arm Function at followup</measure>
    <time_frame>Change from baseline Fugl-Meyer score at 5 months</time_frame>
    <description>clinical test of arm motor ability and impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Action Research Arm Test at followup</measure>
    <time_frame>Change from baseline Action Research Arm Test score at 5 months</time_frame>
    <description>clinical test of the functional limitations of the upper extremities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motor Activity Log at followup</measure>
    <time_frame>Change from baseline Motor Activity Log score at 5 months</time_frame>
    <description>assess the amount and quality of limb use at home</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>HandSOME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is given to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HandSOME</intervention_name>
    <description>Participants use the HandSOME orthosis daily for 8 weeks.</description>
    <arm_group_label>HandSOME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of stroke more than six months prior to entry into the study&#xD;
&#xD;
          2. Impaired ability to open affected the hand&#xD;
&#xD;
          3. At least trace ability to extend the wrist and fingers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have cognitive deficits that could negatively affect their ability to complete the&#xD;
             protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State&#xD;
             Examination&#xD;
&#xD;
          2. Have excessive pain in any joint of the affected extremity that could limit ability to&#xD;
             cooperate with the protocols&#xD;
&#xD;
          3. Have serious uncontrolled medical problems as judged by the project therapist&#xD;
&#xD;
          4. Receiving oral or injected antispasticity medications during study treatment&#xD;
&#xD;
          5. MCP and IP passive extension limit &gt; 30 degrees from full extension&#xD;
&#xD;
          6. Excessive tone in the fingers and thumb as determined by Ashworth scores &gt;=3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MedStar National Rehabilitation Network</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tianyao Chen, Lum PS. Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:578-581. doi: 10.1109/EMBC.2016.7590768.</citation>
    <PMID>28324934</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03263286
org study id: 2016-064
nct id: NCT03263286
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke
      victims regain functional use of their hand and regain independent living. Participants will
      use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes
      from the intervention after the 8 weeks and also at a 3 month followup.
After stroke, individuals often have great difficulty with using the affected hand in
      functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger
      extensor weakness. This leads to increased difficulty in grasp and release of objects.
      HandSOME is a light weight wearable hand orthosis that increases range of motion and
      decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME
      device's effectiveness in the rehabilitation of stroke patients through an 8 week
      intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit
      per week to the clinic to evaluate progress and troubleshoot problems with the device. The
      hypotheses are that the gains from the 8 weeks of training will be statistically significant
      and clinically important (defined as gains of greater than 10% of full scale) in the domains
      of impairment, function and amount of arm use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Fugl-Meyer Test of Arm Function
time frame: Change from baseline Fugl-Meyer score at 2 months
description: clinical test of arm motor ability and impairment
measure: Change in Action Research Arm Test
time frame: Change from baseline Action Research Arm Test score at 2 months
description: clinical test of the functional limitations of the upper extremities
measure: Change in Motor Activity Log
time frame: Change from baseline Motor Activity Log score at 2 months
description: assess the amount and quality of limb use at home
measure: Change in Fugl-Meyer Test of Arm Function at followup
time frame: Change from baseline Fugl-Meyer score at 5 months
description: clinical test of arm motor ability and impairment
measure: Change in Action Research Arm Test at followup
time frame: Change from baseline Action Research Arm Test score at 5 months
description: clinical test of the functional limitations of the upper extremities
measure: Change in Motor Activity Log at followup
time frame: Change from baseline Motor Activity Log score at 5 months
description: assess the amount and quality of limb use at home
arm group label: HandSOME
arm group type: Experimental
description: The intervention is given to this group.
intervention type: Device
intervention name: HandSOME
description: Participants use the HandSOME orthosis daily for 8 weeks.
arm group label: HandSOME
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Tianyao Chen, Lum PS. Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:578-581. doi: 10.1109/EMBC.2016.7590768.
PMID: 28324934
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No