<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/NCT01689883</url>
  </required_header>
  <id_info>
    <org_study_id>2011-P-001592</org_study_id>
    <nct_id>NCT01689883</nct_id>
  </id_info>
  <brief_title>Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors</brief_title>
  <official_title>Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wyss Institute at Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Integration of Medicine &amp; Innovative Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the study is to test whether the use of small electrical currents to&#xD;
      stimulate proprioceptors of the upper limb has potential for improving robot-assisted&#xD;
      upper-limb rehabilitation in stroke survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants will be instructed to perform upper-limb movements using a system designed&#xD;
      for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with&#xD;
      unloading of the stroke-affected arm thus facilitating the performance of upper-limb&#xD;
      movements. The system will be used to track the movements of the stroke-affected arm.&#xD;
      Simultaneously, a custom-designed system (a prototype developed by the investigators) will be&#xD;
      used to deliver small electrical currents to the arm. We hypothesize that the currents&#xD;
      delivered to the arm will improve the accuracy of the movements performed by study&#xD;
      participants.&#xD;
&#xD;
      To assess if delivering small currents to the arm has an effect on the accuracy of the&#xD;
      movements performed by the study participants, they will receive actual stimulation for some&#xD;
      trials and sham stimulation for other trials. Because the investigators will deliver very&#xD;
      small currents, study participants will be unable to perceive such currents and hence tell if&#xD;
      they are performing the movements while receiving actual or sham stimulation. By comparing&#xD;
      trials performed while subjects receive actual stimulation with trials performed while&#xD;
      subjects received sham stimulation, the investigators will determine if the stimulation has&#xD;
      an effect on the accuracy of the movements performed by the subjects.&#xD;
&#xD;
      It is worth noticing that the investigators collected primary outcome data to assess changes&#xD;
      associated with the use of actual stimulation vs sham stimulation. Data during a follow-up&#xD;
      session was also collected, but not for the purpose of collecting outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Actual">August 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>
    <intervention_model_description>The investigators will use a system to inject small currents in the arm while subjects perform upper-limb movements. Subjects will perform multiple trials. During half of the trials, subjects will receive actual stimulation. During the other half, subjects will receive sham stimulation.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Changes in Fugl-Meyer Assessment score with vs without stimulation</time_frame>
    <description>Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jebsen-Taylor Hand Function Test</measure>
    <time_frame>Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation</time_frame>
    <description>Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log</measure>
    <time_frame>Change in Motor Activity Log score with vs without stimulation</time_frame>
    <description>Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>Change in Modified Ashworth Scale score with vs without stimulation</time_frame>
    <description>A therapist examines subjects to assess the severity of spasticity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block test</measure>
    <time_frame>Change in Box and Block test score with vs without stimulation</time_frame>
    <description>Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Change in grip strength with vs without stimulation</time_frame>
    <description>A hand dynamometer is used to measure grip strength</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Chronic Stroke Survivors</condition>
  <arm_group>
    <arm_group_label>Current stimulator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The investigators have developed a device to deliver very small currents to the arm. The device will be used while subjects perform upper-limb movements using a device for upper-limb rehabilitation. Subjects will perform multiple trials of movement. During half of the trials, they will receive actual stimulation. During the other half, they will receive sham stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Current stimulator</intervention_name>
    <description>This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.</description>
    <arm_group_label>Current stimulator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral and cortical, subcortical, or cerebellar stroke&#xD;
&#xD;
          -  6 months post-stroke&#xD;
&#xD;
          -  Upper extremity impairments but able to move upper extremity against gravity 25% of&#xD;
             the range&#xD;
&#xD;
          -  Ability to understand directions and follow simple instructions&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Upper Extremity Fugl-Meyer between 28 and 55&#xD;
&#xD;
          -  At least four (4) months since last botox treatment&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) ≥ 23&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other forms of therapy/ intervention for upper extremity motor&#xD;
             recovery&#xD;
&#xD;
          -  Upper extremity or trunk fractures&#xD;
&#xD;
          -  Severe fixed contractures affecting the upper limbs&#xD;
&#xD;
          -  Severe perceptual deficits or visual field impairments&#xD;
&#xD;
          -  Severe cognitive deficits&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Presence of an implanted electrically operated medical device&#xD;
&#xD;
          -  Evidence of more than one clinical stroke&#xD;
&#xD;
          -  Serious medical or neurological illness&#xD;
&#xD;
          -  History of head trauma or cerebral infectious disease&#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>Paolo Bonato, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spaulding Rehabilitation Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spaulding Rehabilitation Hospital Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>April 20, 2017</last_update_submitted>
  <last_update_submitted_qc>April 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Yong-Tae Lee</investigator_full_name>
    <investigator_title>Physiatrist</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>electrical stimulation</keyword>
  <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/NCT01689883
org study id: 2011-P-001592
nct id: NCT01689883
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of the study is to test whether the use of small electrical currents to
      stimulate proprioceptors of the upper limb has potential for improving robot-assisted
      upper-limb rehabilitation in stroke survivors.
Study participants will be instructed to perform upper-limb movements using a system designed
      for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with
      unloading of the stroke-affected arm thus facilitating the performance of upper-limb
      movements. The system will be used to track the movements of the stroke-affected arm.
      Simultaneously, a custom-designed system (a prototype developed by the investigators) will be
      used to deliver small electrical currents to the arm. We hypothesize that the currents
      delivered to the arm will improve the accuracy of the movements performed by study
      participants.

      To assess if delivering small currents to the arm has an effect on the accuracy of the
      movements performed by the study participants, they will receive actual stimulation for some
      trials and sham stimulation for other trials. Because the investigators will deliver very
      small currents, study participants will be unable to perceive such currents and hence tell if
      they are performing the movements while receiving actual or sham stimulation. By comparing
      trials performed while subjects receive actual stimulation with trials performed while
      subjects received sham stimulation, the investigators will determine if the stimulation has
      an effect on the accuracy of the movements performed by the subjects.

      It is worth noticing that the investigators collected primary outcome data to assess changes
      associated with the use of actual stimulation vs sham stimulation. Data during a follow-up
      session was also collected, but not for the purpose of collecting outcome measures.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The investigators will use a system to inject small currents in the arm while subjects perform upper-limb movements. Subjects will perform multiple trials. During half of the trials, subjects will receive actual stimulation. During the other half, subjects will receive sham stimulation.
primary purpose: Basic Science
masking: None (Open Label)
measure: Fugl-Meyer Assessment
time frame: Changes in Fugl-Meyer Assessment score with vs without stimulation
description: Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)
measure: Jebsen-Taylor Hand Function Test
time frame: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
description: Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
measure: Motor Activity Log
time frame: Change in Motor Activity Log score with vs without stimulation
description: Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
measure: Modified Ashworth Scale
time frame: Change in Modified Ashworth Scale score with vs without stimulation
description: A therapist examines subjects to assess the severity of spasticity
measure: Box and Block test
time frame: Change in Box and Block test score with vs without stimulation
description: Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time
measure: Grip strength
time frame: Change in grip strength with vs without stimulation
description: A hand dynamometer is used to measure grip strength
arm group label: Current stimulator
arm group type: Other
description: The investigators have developed a device to deliver very small currents to the arm. The device will be used while subjects perform upper-limb movements using a device for upper-limb rehabilitation. Subjects will perform multiple trials of movement. During half of the trials, they will receive actual stimulation. During the other half, they will receive sham stimulation.
intervention type: Device
intervention name: Current stimulator
description: This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
arm group label: Current stimulator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paolo Bonato, PhD
role: Principal Investigator
affiliation: Spaulding Rehabilitation Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Yong-Tae Lee
investigator title: Physiatrist
mesh term: Stroke
sharing ipd: No