<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/NCT01725659</url>
  </required_header>
  <id_info>
    <org_study_id>B2801R</org_study_id>
    <nct_id>NCT01725659</nct_id>
  </id_info>
  <brief_title>Innovative Modalities for Restoring Upper Limb Function Post Stroke</brief_title>
  <official_title>Innovative Modalities for Restoring Upper Limb Function Post Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malcom Randall VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Malcom Randall VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE. After stroke many patients are unable to engage in normal upper limb functional&#xD;
      activities, which may restrict them from participation in meaningful life roles. For many,&#xD;
      conventional rehabilitation does not restore upper limb function to a useful level. The&#xD;
      purpose of this research is to investigate the benefits of three promising motor learning&#xD;
      interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning&#xD;
      (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Fugl Meyer</measure>
    <time_frame>after 12 weeks of intervention</time_frame>
    <description>impairment measure of coordination of the upper limb</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Motor Learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects are provided with intensive motor learning training of the upper limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotics and Motor Learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subject are provided with intensive motor learning and robotics training of the upper limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motor learning and FES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motor Learning</intervention_name>
    <description>training of the hemiplegic upper limb with motor learning</description>
    <arm_group_label>Motor Learning</arm_group_label>
    <arm_group_label>Motor learning and FES</arm_group_label>
    <arm_group_label>Robotics and Motor Learning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Robotics</intervention_name>
    <description>subjects perform training of hemiplegic arm using an upper extremity robot</description>
    <arm_group_label>Robotics and Motor Learning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>surface FES</intervention_name>
    <description>subjects are provided with surface FES to the hemiplegic upper limb</description>
    <arm_group_label>Motor learning and FES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;1 year post stroke no acute, uncontrolled medical condition single stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pacemaker other neurological condition more than one stroke&#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>Louis Stokes Cleveland Department of Veterans Affairs Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Malcom Randall VA Medical Center</investigator_affiliation>
    <investigator_full_name>Janis Daly</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>electric stimulation</keyword>
  <keyword>robotics</keyword>
  <keyword>motor learning</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/NCT01725659
org study id: B2801R
nct id: NCT01725659
lead sponsor: 
has dmc: No
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional
      activities, which may restrict them from participation in meaningful life roles. For many,
      conventional rehabilitation does not restore upper limb function to a useful level. The
      purpose of this research is to investigate the benefits of three promising motor learning
      interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning
      (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fugl Meyer
time frame: after 12 weeks of intervention
description: impairment measure of coordination of the upper limb
arm group label: Motor Learning
arm group type: Experimental
description: subjects are provided with intensive motor learning training of the upper limb
arm group label: Robotics and Motor Learning
arm group type: Experimental
description: subject are provided with intensive motor learning and robotics training of the upper limb
arm group label: Motor learning and FES
arm group type: Experimental
description: subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb
intervention type: Other
intervention name: Motor Learning
description: training of the hemiplegic upper limb with motor learning
arm group label: Motor Learning
arm group label: Motor learning and FES
arm group label: Robotics and Motor Learning
intervention type: Other
intervention name: Robotics
description: subjects perform training of hemiplegic arm using an upper extremity robot
arm group label: Robotics and Motor Learning
intervention type: Other
intervention name: surface FES
description: subjects are provided with surface FES to the hemiplegic upper limb
arm group label: Motor learning and FES
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: Malcom Randall VA Medical Center
investigator full name: Janis Daly
investigator title: Principal Investigator
mesh term: Stroke