<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/NCT03292276</url>
  </required_header>
  <id_info>
    <org_study_id>44/2016</org_study_id>
    <nct_id>NCT03292276</nct_id>
  </id_info>
  <brief_title>Improving Hand Motor Function After Stroke: Role of Robotics</brief_title>
  <official_title>Improving Hand Motor Function After Stroke: Role of Robotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two recent randomized clinical trials reported a significant contribute of Amadeo toward the&#xD;
      recovery of hand motor function in acute stroke patients in association with physiotherapy&#xD;
      and/or occupational therapy. However, no data are available in patients with chronic stroke,&#xD;
      and the neurophysiological mechanisms underlying such clinical improvement need to be&#xD;
      elucidated. Given that robotic devices harness brain plasticity to foster motor function&#xD;
      recovery, a deeper understanding of the neurophysiological bases of Amadeo training could&#xD;
      help clinician to realize patient-tailored rehabilitative training based brain plasticity&#xD;
      knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the&#xD;
      effects of intensive robot-assisted hand therapy compared with intensive occupational therapy&#xD;
      in chronic phase after stroke. We estimated that 40 patients per group will be required to&#xD;
      demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect&#xD;
      size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and&#xD;
      randomized into two groups. The experimental group will be provided with Amadeo training. The&#xD;
      Control group will be provided with occupational therapy executed by a trained&#xD;
      physiotherapist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 20, 2018</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nine hole peg test</measure>
    <time_frame>by 5 minutes</time_frame>
    <description>Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested. Only the hand being evaluated should perform the test. Hand not being evaluated is permitted to hold the edge of the board in order to provide stability. Scores are based on the time taken to complete the test activity, recorded in seconds. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second. Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cortical modifications related to movement preparation and execution after robot-assisted training</measure>
    <time_frame>about 30 minutes</time_frame>
    <description>Assessment of EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity</condition>
  <arm_group>
    <arm_group_label>Amadeo training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The robotic exercises will be carried in passive modality (15 minutes), passive/plus (15 minutes), assisted modality (15 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>occupational therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The control group will receive the same amount of training by physiotherapist skilled in occupational tharapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amadeo Training</intervention_name>
    <description>To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).&#xD;
Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups.</description>
    <arm_group_label>Amadeo training</arm_group_label>
    <arm_group_label>occupational therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic stroke patients at their first-ever supratentorial stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of severe medical, psychiatric and cognitive abnormalities as to interfere&#xD;
             with the treatment.&#xD;
&#xD;
          -  controindications to the device use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Placido Bramanti</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS Neurolesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</name>
      <address>
        <city>Messina</city>
        <zip>98124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</investigator_affiliation>
    <investigator_full_name>Rocco Salvatore Calabrò</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <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/NCT03292276
org study id: 44/2016
nct id: NCT03292276
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Two recent randomized clinical trials reported a significant contribute of Amadeo toward the
      recovery of hand motor function in acute stroke patients in association with physiotherapy
      and/or occupational therapy. However, no data are available in patients with chronic stroke,
      and the neurophysiological mechanisms underlying such clinical improvement need to be
      elucidated. Given that robotic devices harness brain plasticity to foster motor function
      recovery, a deeper understanding of the neurophysiological bases of Amadeo training could
      help clinician to realize patient-tailored rehabilitative training based brain plasticity
      knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the
      effects of intensive robot-assisted hand therapy compared with intensive occupational therapy
      in chronic phase after stroke. We estimated that 40 patients per group will be required to
      demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect
      size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and
      randomized into two groups. The experimental group will be provided with Amadeo training. The
      Control group will be provided with occupational therapy executed by a trained
      physiotherapist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Nine hole peg test
time frame: by 5 minutes
description: Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested. Only the hand being evaluated should perform the test. Hand not being evaluated is permitted to hold the edge of the board in order to provide stability. Scores are based on the time taken to complete the test activity, recorded in seconds. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second. Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container.
measure: cortical modifications related to movement preparation and execution after robot-assisted training
time frame: about 30 minutes
description: Assessment of EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).
arm group label: Amadeo training
arm group type: Experimental
description: All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The robotic exercises will be carried in passive modality (15 minutes), passive/plus (15 minutes), assisted modality (15 minutes).
arm group label: occupational therapy
arm group type: Active Comparator
description: All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The control group will receive the same amount of training by physiotherapist skilled in occupational tharapy.
intervention type: Device
intervention name: Amadeo Training
description: To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).
Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups.
arm group label: Amadeo training
arm group label: occupational therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Placido Bramanti
role: Study Chair
affiliation: IRCCS Neurolesi
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Centro Neurolesi "Bonino-Pulejo"
investigator full name: Rocco Salvatore Calabrò
investigator title: MD PhD
sharing ipd: No