<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/NCT04484571</url>
  </required_header>
  <id_info>
    <org_study_id>NEEM20160118</org_study_id>
    <nct_id>NCT04484571</nct_id>
  </id_info>
  <brief_title>Multimodal Instrumented Assessment of Post-stroke Elbow</brief_title>
  <official_title>Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda USL Toscana Nord Ovest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scuola Superiore Sant'Anna Pisa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda USL Toscana Nord Ovest</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic&#xD;
      exoskeleton, for the passive mobilization and active training of elbow flexion and extension&#xD;
      in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or&#xD;
      spasticity) of the right arm. The study protocol is a randomized controlled trial consisting&#xD;
      of a 4-week functional rehabilitation program, with both clinical and robotically&#xD;
      instrumented assessments to be conducted at baseline and post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are&#xD;
      essential clinical objectives in the early rehabilitation from stroke and other neurological&#xD;
      disorders, to prevent the progression of neuromuscular pathology and enable proactive&#xD;
      physiotherapy towards functional recovery. However, the current clinical evaluation and&#xD;
      treatment of this stiffness (and underlying muscle spasticity) are severely limited by their&#xD;
      dependence on subjective evaluation and manual limb mobilization, thus rendering the&#xD;
      evaluation imprecise and the treatment insufficiently tailored to the specific pathologies&#xD;
      and residual capabilities of individual patients. To address these needs, the proposed&#xD;
      clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton,&#xD;
      for the passive mobilization and active training of elbow flexion and extension in stroke&#xD;
      patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study&#xD;
      protocol provide a functional rehabilitation program, with both clinical and robotically&#xD;
      instrumented assessments to be conducted at baseline and post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2024</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>
    <intervention_model_description>Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Indipendent assessor blinded on treatment provided</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better</measure>
    <time_frame>before and within 1 week after 4 weeks of treatment</time_frame>
    <description>It is a clinical scale used for the assessment of motor function in stroke patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse</measure>
    <time_frame>Before and within 1 week after 4 weeks of treatment</time_frame>
    <description>It is a clinical scale for spasticity assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Maximum Extension Torque (MET)</measure>
    <time_frame>Before and within 1 week after 4 weeks of treatment</time_frame>
    <description>It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Zero Torque Angle (ZTA)</measure>
    <time_frame>Before and within 1 week after 4 weeks of treatment</time_frame>
    <description>It is the angular value corresponding to null torque exerted by the robot; in this configuration, flexor and extensor torques are equal and opposite and the system is ideally not applying any force to hold the elbow in position, which has reached its equilibrium point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Joint Impedance (JIMP)</measure>
    <time_frame>Before and within 1 week after 4 weeks of treatment</time_frame>
    <description>A measure of the limb resistance to muscle elongation, extracted as the ratio between joint torque and joint angular position for constant, slow-speed movements, the main contribution to the joint impedance can be identified in the joint stiffness (i.e. rigidity).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Spasticity, Muscle</condition>
  <condition>Stroke</condition>
  <condition>Upper Limb</condition>
  <arm_group>
    <arm_group_label>Robotic treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuroexsos elbow module</intervention_name>
    <description>The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs</description>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_label>Robotic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper limb spasticity due to neurological impairment;&#xD;
&#xD;
          -  Cognitive abilities sufficient for understanding instructions;&#xD;
&#xD;
          -  Absence of severe pain assessed as Visual Analogic Score (VAS) &lt; 4 (range 0-10).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable general clinical conditions;&#xD;
&#xD;
          -  Inability to keep sitting posture;&#xD;
&#xD;
          -  Tendon retractions limiting upper limb joints range of motion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale Versilia</name>
      <address>
        <city>Camaiore</city>
        <state>Lucca</state>
        <zip>55041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2023</last_update_submitted>
  <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda USL Toscana Nord Ovest</investigator_affiliation>
    <investigator_full_name>Federico Posteraro</investigator_full_name>
    <investigator_title>Head of North Area Rehabilitation Department</investigator_title>
  </responsible_party>
  <keyword>Robotics</keyword>
  <keyword>Upper extremities</keyword>
  <keyword>EMG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <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/NCT04484571
org study id: NEEM20160118
nct id: NCT04484571
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic
      exoskeleton, for the passive mobilization and active training of elbow flexion and extension
      in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or
      spasticity) of the right arm. The study protocol is a randomized controlled trial consisting
      of a 4-week functional rehabilitation program, with both clinical and robotically
      instrumented assessments to be conducted at baseline and post-treatment.
The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are
      essential clinical objectives in the early rehabilitation from stroke and other neurological
      disorders, to prevent the progression of neuromuscular pathology and enable proactive
      physiotherapy towards functional recovery. However, the current clinical evaluation and
      treatment of this stiffness (and underlying muscle spasticity) are severely limited by their
      dependence on subjective evaluation and manual limb mobilization, thus rendering the
      evaluation imprecise and the treatment insufficiently tailored to the specific pathologies
      and residual capabilities of individual patients. To address these needs, the proposed
      clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton,
      for the passive mobilization and active training of elbow flexion and extension in stroke
      patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study
      protocol provide a functional rehabilitation program, with both clinical and robotically
      instrumented assessments to be conducted at baseline and post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Clinical Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Indipendent assessor blinded on treatment provided
measure: Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better
time frame: before and within 1 week after 4 weeks of treatment
description: It is a clinical scale used for the assessment of motor function in stroke patients
measure: Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse
time frame: Before and within 1 week after 4 weeks of treatment
description: It is a clinical scale for spasticity assessment
measure: Change in Maximum Extension Torque (MET)
time frame: Before and within 1 week after 4 weeks of treatment
description: It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle
measure: Change in Zero Torque Angle (ZTA)
time frame: Before and within 1 week after 4 weeks of treatment
description: It is the angular value corresponding to null torque exerted by the robot; in this configuration, flexor and extensor torques are equal and opposite and the system is ideally not applying any force to hold the elbow in position, which has reached its equilibrium point
measure: Change in Joint Impedance (JIMP)
time frame: Before and within 1 week after 4 weeks of treatment
description: A measure of the limb resistance to muscle elongation, extracted as the ratio between joint torque and joint angular position for constant, slow-speed movements, the main contribution to the joint impedance can be identified in the joint stiffness (i.e. rigidity).
arm group label: Robotic treatment
arm group type: Experimental
description: Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton
arm group label: Conventional treatment
arm group type: Active Comparator
description: Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time
intervention type: Device
intervention name: Neuroexsos elbow module
description: The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs
arm group label: Conventional treatment
arm group label: Robotic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda USL Toscana Nord Ovest
investigator full name: Federico Posteraro
investigator title: Head of North Area Rehabilitation Department
mesh term: Muscle Spasticity
mesh term: Stroke
sharing ipd: No