<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/NCT01726660</url>
  </required_header>
  <id_info>
    <org_study_id>11-121B</org_study_id>
    <nct_id>NCT01726660</nct_id>
  </id_info>
  <brief_title>The General Use of Robots in Stroke Recovery</brief_title>
  <official_title>Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if tailoring multiple sessions of upper extremity&#xD;
      robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming;&#xD;
      active range of motion vs. functional practice)can optimize therapeutic results and lead to&#xD;
      greater functional returns in arm mobility after stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unfunded&#xD;
  </why_stopped>
  <start_date type="Actual">February 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Upper Extremity Fugl Meyer Motor Assessment</measure>
    <time_frame>12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Kinematic Data</measure>
    <time_frame>12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)</time_frame>
    <description>Kinematic Data recorded during therapy with IMT robots</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Fugl Meyer Sensation Scale</measure>
    <time_frame>12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Fugl Meyer Proprioception Scale</measure>
    <time_frame>12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>IMT Robotic Arm Therapy: Aim training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMT Robotic Arm Therapy: Smoothness Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMT Robotic Arm Therapy: Impairment training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMT Robotic Arm Therapy: Functional training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMT Robotic Arm therapy</intervention_name>
    <description>Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy</description>
    <arm_group_label>IMT Robotic Arm Therapy: Aim training</arm_group_label>
    <arm_group_label>IMT Robotic Arm Therapy: Functional training</arm_group_label>
    <arm_group_label>IMT Robotic Arm Therapy: Impairment training</arm_group_label>
    <arm_group_label>IMT Robotic Arm Therapy: Smoothness Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  First single focal unilateral lesion with diagnosis verified by brain imaging, which&#xD;
             occurred at least 6 months prior&#xD;
&#xD;
          -  Cognitive function sufficient enough to understand experiments and follow instructions&#xD;
&#xD;
          -  Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully&#xD;
             recovered motor function in the muscles of the shoulder, elbow, and wrist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior experience with robotic arm therapy&#xD;
&#xD;
          -  Fixed contraction of the affected limb&#xD;
&#xD;
          -  Complete flaccid paralysis of the affected limb&#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>Bruce T Volpe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Feinstein Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Feinstein Institute for Medical Research</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.</citation>
    <PMID>15314537</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Bruce Volpe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Cerebrovascular Accident</keyword>
  <keyword>Cerebral stroke</keyword>
  <keyword>CVA</keyword>
  <keyword>robotic therapy</keyword>
  <keyword>upper extremity recovery</keyword>
  <keyword>kinematic training</keyword>
  <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/NCT01726660
org study id: 11-121B
nct id: NCT01726660
lead sponsor: 
has dmc: No
The purpose of this study is to determine if tailoring multiple sessions of upper extremity
      robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming;
      active range of motion vs. functional practice)can optimize therapeutic results and lead to
      greater functional returns in arm mobility after stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
measure: Change from baseline in Kinematic Data
time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
description: Kinematic Data recorded during therapy with IMT robots
measure: Change from baseline in Fugl Meyer Sensation Scale
time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
measure: Change from baseline in Fugl Meyer Proprioception Scale
time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
arm group label: IMT Robotic Arm Therapy: Aim training
arm group type: Experimental
description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
arm group label: IMT Robotic Arm Therapy: Smoothness Training
arm group type: Experimental
description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
arm group label: IMT Robotic Arm Therapy: Impairment training
arm group type: Experimental
description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
arm group label: IMT Robotic Arm Therapy: Functional training
arm group type: Experimental
description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
intervention type: Device
intervention name: IMT Robotic Arm therapy
description: Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
arm group label: IMT Robotic Arm Therapy: Aim training
arm group label: IMT Robotic Arm Therapy: Functional training
arm group label: IMT Robotic Arm Therapy: Impairment training
arm group label: IMT Robotic Arm Therapy: Smoothness Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruce T Volpe, MD
role: Principal Investigator
affiliation: Feinstein Institute for Medical Research
facility: 
country: United States
citation: Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.
PMID: 15314537
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Bruce Volpe
investigator title: Principal Investigator
mesh term: Stroke