<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/NCT03243123</url>
  </required_header>
  <id_info>
    <org_study_id>201701</org_study_id>
    <nct_id>NCT03243123</nct_id>
  </id_info>
  <brief_title>Upper Limb Robotic Rehabilitation After Stroke</brief_title>
  <official_title>Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm study aimed at evaluating the acute effects induced by a single session&#xD;
      of robot-assisted passive hand mobilization on local perfusion and upper limb function in&#xD;
      post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke&#xD;
      received 20 min passive mobilization of the paretic hand with robotic assistance. After the&#xD;
      intervention, significant improvements were found in forearm perfusion, muscle tone&#xD;
      significantly decreased and subjects reported decreased upper limb heaviness, stiffness and&#xD;
      pain. This study supports novel evidence that hand robotic assistance promotes local forearm&#xD;
      circulation, may help in the management of spasticity and acutely alleviates reported&#xD;
      symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">December 23, 2014</completion_date>
  <primary_completion_date type="Actual">November 15, 2014</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>Forearm perfusion</measure>
    <time_frame>30 minutes</time_frame>
    <description>Amount of total hemoglobin circulating in the forearm muscle tissues.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle tone</measure>
    <time_frame>30 minutes</time_frame>
    <description>The tone of the muscle assessed with Modified Ashworth Scale</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Passive mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Upper limb passive mobilization assisted with robotic device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic passive mobilization</intervention_name>
    <description>The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.</description>
    <arm_group_label>Passive mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first event of cerebrovascular stroke; unilateral paresis; ability to remain in&#xD;
             sitting position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion&#xD;
             contracture; degenerative or non degenerative neurological conditions; refusal or&#xD;
             inability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Massimiliano Gobbo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </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/NCT03243123
org study id: 201701
nct id: NCT03243123
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a single arm study aimed at evaluating the acute effects induced by a single session
      of robot-assisted passive hand mobilization on local perfusion and upper limb function in
      post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke
      received 20 min passive mobilization of the paretic hand with robotic assistance. After the
      intervention, significant improvements were found in forearm perfusion, muscle tone
      significantly decreased and subjects reported decreased upper limb heaviness, stiffness and
      pain. This study supports novel evidence that hand robotic assistance promotes local forearm
      circulation, may help in the management of spasticity and acutely alleviates reported
      symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Forearm perfusion
time frame: 30 minutes
description: Amount of total hemoglobin circulating in the forearm muscle tissues.
measure: Muscle tone
time frame: 30 minutes
description: The tone of the muscle assessed with Modified Ashworth Scale
arm group label: Passive mobilization
arm group type: Experimental
description: Upper limb passive mobilization assisted with robotic device
intervention type: Device
intervention name: Robotic passive mobilization
description: The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.
arm group label: Passive mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Massimiliano Gobbo
investigator title: MD
mesh term: Stroke
sharing ipd: No