<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/NCT04449328</url>
  </required_header>
  <id_info>
    <org_study_id>19CH113</org_study_id>
    <secondary_id>2019-A01673-54</secondary_id>
    <nct_id>NCT04449328</nct_id>
  </id_info>
  <brief_title>Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects</brief_title>
  <acronym>OPTIVIBE</acronym>
  <official_title>Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Two movement illusion techniques can currently be used in clinical practice for motor&#xD;
      rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive&#xD;
      illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey,&#xD;
      Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a&#xD;
      visual feedback of a correctly realized movement. The proprioceptive illusion is based on the&#xD;
      external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz.&#xD;
      These two techniques are currently used independently. They are, in theory, complementary and&#xD;
      additive. No study has described the combinatorial properties of the illusions generated by&#xD;
      these 2 techniques in hemiplegic subjects and healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study hypothesis is that the administration of mirror therapy together with vibration&#xD;
      will increase the perception of movement in a subjective scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2021</start_date>
  <completion_date type="Actual">April 28, 2023</completion_date>
  <primary_completion_date type="Actual">April 25, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured nature of this impression of movement (flexion/extension)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured by Kinovea software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of motor intention in hemiplegic subjects by experimental conditions</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment</measure>
    <time_frame>Day: 0</time_frame>
    <description>Level of motor impairment is measured by Medical Research Council (MRC) score. Medical Research Council (MRC) score evaluate motricity (0= paralyzed).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score</measure>
    <time_frame>Day: 0</time_frame>
    <description>Erasmus modified Nottingham Sensory Assessment (EmNSA) score evaluated the level of sensory impairment.&#xD;
The Erasmus modified Nottingham Sensory Assessment (EmNSA) includes 2 subscales: somatosensory score (min 0 and max 44) and stereognosis (min 0 and max 20) for left and right members.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Measured by Kinovea software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.</measure>
    <time_frame>Day: 0, 7</time_frame>
    <description>Multi Channel EEG Acquisition System</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>Patient with first stroke causing hemiplegic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with first stroke causing hemiplegic will be included.&#xD;
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:&#xD;
Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))&#xD;
Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Healthy subjects will be included.&#xD;
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:&#xD;
Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))&#xD;
Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computerized Mirror Therapy (CMT)</intervention_name>
    <description>Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3).&#xD;
The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand.</description>
    <arm_group_label>Patient with first stroke causing hemiplegic</arm_group_label>
    <arm_group_label>healthy subjects</arm_group_label>
    <other_name>Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tendon vibration</intervention_name>
    <description>Transcutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz.</description>
    <arm_group_label>Patient with first stroke causing hemiplegic</arm_group_label>
    <arm_group_label>healthy subjects</arm_group_label>
    <other_name>Vibrasens, VB115, Techno Concept, France</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hemiplegic subjects :&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Aged 18 to 70 years,&#xD;
&#xD;
          -  First ischemic or hemorrhagic stroke causing hemiplegic&#xD;
&#xD;
          -  Having signed the written consent&#xD;
&#xD;
          -  Affiliated or entitled to a social security scheme&#xD;
&#xD;
        Healthy subjects :&#xD;
&#xD;
          -  Male or female, aged 18 to 70 years,&#xD;
&#xD;
          -  Matched in sex, age and laterally with hemiplegic subjects&#xD;
&#xD;
          -  Having signed the written consent&#xD;
&#xD;
          -  Affiliated or entitled to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Hemiplegic subjects :&#xD;
&#xD;
          -  With complete lesion of the primary motor cortex&#xD;
&#xD;
          -  With an addiction to alcohol or drugs&#xD;
&#xD;
          -  With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy,&#xD;
             malignant illness severe kidney or lung disease&#xD;
&#xD;
          -  With history of associated general disabling disease&#xD;
&#xD;
          -  With cerebellar syndrome&#xD;
&#xD;
          -  With clinical brain stem involvement&#xD;
&#xD;
          -  Under legal protection&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
        Healthy subjects :&#xD;
&#xD;
          -  Neurological, cardiovascular, musculoskeletal diseases&#xD;
&#xD;
          -  Taking medication that can affect attention&#xD;
&#xD;
          -  Unable to understand instructions of the study&#xD;
&#xD;
          -  Under legal protection&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal GIRAUX, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Computerized Mirror Therapy (CMT)</keyword>
  <keyword>Intensive Visual Simulation3 (IVS3)</keyword>
  <keyword>Vibration</keyword>
  <keyword>Vibrasens</keyword>
  <keyword>Upper limb rehabilitation</keyword>
  <keyword>Stroke</keyword>
  <keyword>Hemiplegic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</mesh_term>
    <mesh_term>Illusions</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/NCT04449328
org study id: 19CH113
secondary id: 2019-A01673-54
nct id: NCT04449328
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two movement illusion techniques can currently be used in clinical practice for motor
      rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive
      illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey,
      Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a
      visual feedback of a correctly realized movement. The proprioceptive illusion is based on the
      external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz.
      These two techniques are currently used independently. They are, in theory, complementary and
      additive. No study has described the combinatorial properties of the illusions generated by
      these 2 techniques in hemiplegic subjects and healthy subjects.
The study hypothesis is that the administration of mirror therapy together with vibration
      will increase the perception of movement in a subjective scale.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7
time frame: Day: 0, 7
description: Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)
measure: subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7
time frame: Day: 0, 7
description: Measured nature of this impression of movement (flexion/extension)
measure: subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7
time frame: Day: 0, 7
description: Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)
measure: Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
time frame: Day: 0, 7
description: Measured by Kinovea software.
measure: Measurement of motor intention in hemiplegic subjects by experimental conditions
time frame: Day: 0, 7
description: Measured by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement).
measure: To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment
time frame: Day: 0
description: Level of motor impairment is measured by Medical Research Council (MRC) score. Medical Research Council (MRC) score evaluate motricity (0= paralyzed).
measure: To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score
time frame: Day: 0
description: Erasmus modified Nottingham Sensory Assessment (EmNSA) score evaluated the level of sensory impairment.
The Erasmus modified Nottingham Sensory Assessment (EmNSA) includes 2 subscales: somatosensory score (min 0 and max 44) and stereognosis (min 0 and max 20) for left and right members.
measure: Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm
time frame: Day: 0, 7
description: Measured by Kinovea software.
measure: Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.
time frame: Day: 0, 7
description: Multi Channel EEG Acquisition System
arm group label: Patient with first stroke causing hemiplegic
arm group type: Experimental
description: Patient with first stroke causing hemiplegic will be included.
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:
Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))
Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.
arm group label: healthy subjects
arm group type: Sham Comparator
description: Healthy subjects will be included.
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:
Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))
Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.
intervention type: Device
intervention name: Computerized Mirror Therapy (CMT)
description: Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3).
The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand.
arm group label: Patient with first stroke causing hemiplegic
arm group label: healthy subjects
other name: Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France
intervention type: Device
intervention name: Tendon vibration
description: Transcutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz.
arm group label: Patient with first stroke causing hemiplegic
arm group label: healthy subjects
other name: Vibrasens, VB115, Techno Concept, France
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal GIRAUX, PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemiplegia
mesh term: Illusions
sharing ipd: No