<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/NCT04441164</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_8897_VERARE</org_study_id>
    <secondary_id>2020-A01722-37</secondary_id>
    <nct_id>NCT04441164</nct_id>
  </id_info>
  <brief_title>VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness</brief_title>
  <acronym>VERARE</acronym>
  <official_title>VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de Recherche en Informatique et en Automatique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes University 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>
      After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually&#xD;
      have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to&#xD;
      treatments which had to be used. This disease is expected to be similar or even higher in&#xD;
      patients suffering from COVID-19 and hospitalized in ICU due to the average length of&#xD;
      hospitalization of several weeks in this population. This condition will delay the&#xD;
      return-to-walk of these patients, their discharge from hospitalization and may deteriorate&#xD;
      their autonomy in daily life activities.&#xD;
&#xD;
      Virtual Reality (VR) environments are already used and have proven their worth for the&#xD;
      assessment and rehabilitation of patients with neurological diseases. It therefore seems&#xD;
      appropriate to offer the use of virtual environments for this type of population. VR&#xD;
      represents a unique opportunity for the rehabilitation care of these patients, and in&#xD;
      particular those who have been reached by COVID-19, due to the possible mismatch between the&#xD;
      amount of motor rehabilitation to be provided and the fatigability and breathlessness at the&#xD;
      slightest effort which seem particularly intense in this population.&#xD;
&#xD;
      The main objective of our project is to improve and to accelerate gait recovery in patients&#xD;
      hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or&#xD;
      Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness&#xD;
      secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual&#xD;
      Reality tools. The VR tool will consist of virtual environments presented using a Virtual&#xD;
      Reality headset where an avatar (double) of the patient hospitalized in Physical and&#xD;
      Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks&#xD;
      involving their lower limbs (ex: walking, or kicking a ball) in several different virtual&#xD;
      environments (settings). The patient will be asked to observe actions, then to imagine&#xD;
      carrying out their actions which will be performed by the avatar in the virtual environment,&#xD;
      then they will be able to control the actions of the avatar using their legs thanks to&#xD;
      sensors, then feel walking sensations through the use of haptic devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Step 1: The objective is to evaluate the effectiveness of the Observation of Virtual Actions&#xD;
      on gait recovery in patients hospitalized in Physical and Rehabilitation Medicine (MPR) and&#xD;
      presenting ICU-weakness, in particular following a COVID-19 infection. If the patient is&#xD;
      included in the Virtual Reality group, they will be asked to observe once a day for 9 days&#xD;
      for 5 minutes Virtual Motor Actions (avatar moving in a virtual environment) using a headset.&#xD;
      Virtual Reality, followed by 5 minutes of relaxation performed using soothing music played&#xD;
      through headphones. If the patient is included in the Relaxation group, they will be offered&#xD;
      10 minutes of relaxation performed using soothing music played in headphones once a day for 9&#xD;
      days. We will assess gait, motive power, balance, confidence in the future and patient&#xD;
      autonomy before the start of the first session, the day after the last session and one month&#xD;
      after inclusion. At the end of each session, we will ask the patient questions about fatigue&#xD;
      (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality&#xD;
      headset or headset. At the end of the 9 sessions, we will ask to patients in the Virtual&#xD;
      Reality group to complete a questionnaire concerning the acceptance of the proposed device.&#xD;
      We want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation&#xD;
      group.&#xD;
&#xD;
      Step 2: The objective is to assess the acceptability (a priori) of the Virtual Reality tool&#xD;
      created in ICU by the nursing staff and by the patients who are hospitalized there. It will&#xD;
      be offered to caregivers of the ICU of the Rennes University Hospital and to patients&#xD;
      hospitalized in these 2 services and presenting ICU- weakness, especially in the aftermath of&#xD;
      COVID infection. We will be asked to complete an acceptability questionnaire (a priori)&#xD;
      concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The&#xD;
      duration of filling in this questionnaire is estimated at 30 minutes. Caregivers will be&#xD;
      invited to participate in an information meeting (4 will be carried out) at least 1 week&#xD;
      before their possible participation (which they will be informed by internal mail, and which&#xD;
      will be led by investigators). We believe that approximately 300 caregivers and 50 patients&#xD;
      will participate in this acceptability survey.&#xD;
&#xD;
      Step 3: The objective is to evaluate the effectiveness of the Observation of Virtual Actions&#xD;
      on gait recovery in patients hospitalized in ICU and with ICU-weakness. If the acceptability&#xD;
      questionnaire is in favor of a good future acceptance of the tool designed and after possible&#xD;
      adaptations of the Virtual Reality device based on the responses of caregivers and patients&#xD;
      to the acceptability questionnaire proposed during the step 2, we will suggest to patients&#xD;
      hospitalized in ICU with ICU-weakness to carry out a protocol similar to that carried out&#xD;
      with Physical and Rehabilitation Medicine patients in step 1. If the patient is included in&#xD;
      the Virtual Reality group, they will be asked to observe once a day for 9 days for 5 minutes&#xD;
      Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality&#xD;
      headset, followed by 5 minutes of relaxation performed using soothing music played through&#xD;
      headphones. If the patient is included in the Relaxation group, they will be offered 10&#xD;
      minutes of relaxation performed using soothing music played in headphones once a day for 9&#xD;
      days. We will assess gait, motive power, balance, confidence in the future and patient&#xD;
      autonomy before the start of the first session, the day after the last session and 1 month&#xD;
      after inclusion. At the end of each session, we will ask the patient questions about fatigue&#xD;
      (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality&#xD;
      headset. At the end of the 9 sessions, we will suggest to patients in the Virtual Reality&#xD;
      group that they complete a questionnaire concerning the acceptance of the proposed device. We&#xD;
      want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation&#xD;
      group.&#xD;
&#xD;
      Step 4: The objective is to assess the effectiveness of the realization of virtual actions&#xD;
      compared to the observation of virtual actions on gait recovery in patients hospitalized in&#xD;
      ICU or in Physical and Rehabilitation Medicine and presenting ICU-weakness. If the patient is&#xD;
      included in the group Performing Virtual Actions, they will be asked to perform Virtual&#xD;
      Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to&#xD;
      move around in a virtual environment for 10 minutes per day, once a day for 9 days. If the&#xD;
      patient is included in the Observation of Virtual Actions group, they will be asked to&#xD;
      observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a&#xD;
      virtual environment) using a Virtual Reality headset. We will assess gait, motive power,&#xD;
      balance, confidence in the future and patient autonomy before the start of the first session,&#xD;
      the day after the last session and 1 month after inclusion. At the end of each session, we&#xD;
      will ask the patient questions about fatigue (VAS) and the occurrence of side effects (open&#xD;
      question) after wearing the Virtual Reality headset. At the end of the 9 sessions, we will&#xD;
      offer patients to fill out a questionnaire concerning the acceptance of the proposed device.&#xD;
      We want to include 20 patients in the Virtual Actions group and 20 patients in the Virtual&#xD;
      Actions Observation group.&#xD;
&#xD;
      Step 5: The objective is to evaluate the effectiveness of adding a sensation of walking using&#xD;
      haptic stimuli during the Observation or Realization of Virtual Actions on the recovery of&#xD;
      walking in patients hospitalized in ICU or in Physical and Rehabilitation Medicine and with&#xD;
      ICU-weakness. Depending on the superiority or not of the Realization of Virtual Actions or&#xD;
      the Observation of Virtual Actions, we will test the most effective condition of step 4 in&#xD;
      combination with: either haptic stimulation (sensory feedback through vibrators positioned on&#xD;
      the lower limbs to give a feeling of walking), either without haptic stimulation, once a day&#xD;
      for 10 minutes for 9 days. We will assess gait, motive power, balance, confidence in the&#xD;
      future and patient autonomy before the start of the first session, the day after the last&#xD;
      session and 1 month after inclusion. At the end of each session, we will ask the patient&#xD;
      questions about fatigue (VAS) and the occurrence of side effects (open question) in the&#xD;
      aftermath of wearing a Virtual Reality headset. At the end of the 9 sessions, we will offer&#xD;
      patients to fill out a questionnaire concerning the acceptance of the proposed device. We&#xD;
      want to include 20 patients in the group with haptic stimulation and 20 patients in the group&#xD;
      without haptic stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Submitted, denied (too much steps; project to be cut in several projects)&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Step 1: 40 patients (20 in the Virtual Reality group and 20 in the Relaxation group)&#xD;
Step 2: Estimated response rate of approximately 300 caregivers and 50 patients&#xD;
Step 3: 40 patients (20 in the Virtual Reality group and 20 in the Relaxation group)&#xD;
Step 4: 40 patients (20 in the group Performing Virtual Actions and 20 in the group Observing Virtual Actions)&#xD;
Step 5: 40 patients (20 in the group with Haptic stimulation, 20 in the group without Haptic stimulation</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-minute test</measure>
    <time_frame>Day 10</time_frame>
    <description>Number of meters taken during the 6-minute test the day after the last session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for 10-meter test</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 10-meter test (time in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 6-minute walk test (need for breaks, scale de Borg, existence of desaturation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery time</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: recovery time for walking over 10 meters without human or technical assistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normal or deficient posture balance in sitting and standing</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: normal or deficient posture balance in sitting and standing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale. Berg's balance scale includes 14 tests that assess static balance and dynamic balance. Each test is rated from 0 (needs help) to 4 (can do on him/her own). Total score is on 56 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go test</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Timed Up and Go test (time in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration for the test of the 10 chair lifts</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: test of the 10 chair lifts (duration in seconds, existence of a desaturation, Borg scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRC scale</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Strength assessment before the start of the first session, the day after the last session and within 1 month of inclusion: MRC testing of the lower limbs.&#xD;
The Medical Research Council's scale (MRC scale) is an assessment of muscle power, rated form 0 (no contraction) to 5 (normal power).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of autonomy before the start of the first session, the day after the last session and within 1 month of inclusion: Functional Independence Measure.&#xD;
The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory). Multiple studies support the reliability and validity of FIM scales in the older population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Day 1 (step 2)</time_frame>
    <description>Acceptability (a priori, patients and caregivers for stage 2) questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance</measure>
    <time_frame>Day 1 (step 2)</time_frame>
    <description>Acceptance (patients for stages 1, 3, 4 and 5) questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>End of each session, at days 1 to 9</time_frame>
    <description>Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Undesirable effects</measure>
    <time_frame>End of each session, at days 1 to 9</time_frame>
    <description>Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence in the future</measure>
    <time_frame>Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion</time_frame>
    <description>Assessment of confidence in the future using a questionnaire (steps 1, 3, 4, 5) before the start of the first session, the day after the last session and 1 month from inclusion</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Weakness of the Lower Limbs</condition>
  <arm_group>
    <arm_group_label>Observation of Virtual Actions (steps 1 and 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is included in the Virtual Reality group, he/she will be asked to observe Virtual Motor Actions (their own avatar moving in a virtual environment) using a headset once a day for 9 days during 5 minutes, followed by 5 minutes of relaxation performed using soothing music played through headphones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>It will be offered to patients hospitalized in these 2 services and presenting post-resuscitation ICU-weakness, especially in the aftermath of COVID infection, to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>It will be offered to caregivers of the ICU of the Rennes University Hospital, to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation (step 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Performing Virtual Actions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is included in the group Performing Virtual Actions, he/she will be asked to perform Virtual Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to move around in a virtual environment for 10 minutes per day, once a day for 9 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation of Virtual Actions</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>If the patient is included in the Observation of Virtual Actions group, he/she will be asked to observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality headset.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haptic stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of step 4 in combination with haptic stimulation (sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without haptic stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Without haptic stimulation Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of Step 4 in combination without haptic stimulation (without sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of Virtual Actions</intervention_name>
    <description>If the patient is included in the Virtual Reality group, he/she will be asked to observe Virtual Motor Actions (their own avatar moving in a virtual environment) using a headset once a day for 9 days during 5 minutes, followed by 5 minutes of relaxation performed using soothing music played through headphones.</description>
    <arm_group_label>Observation of Virtual Actions (steps 1 and 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Relaxation</intervention_name>
    <description>If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.</description>
    <arm_group_label>Relaxation</arm_group_label>
    <arm_group_label>Relaxation (step 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acceptability questionnaire</intervention_name>
    <description>It will be asked to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of Virtual Actions (step 4)</intervention_name>
    <description>If the patient is included in the Observation of Virtual Actions group, he/she will be asked to observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality headset.</description>
    <arm_group_label>Observation of Virtual Actions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Performing Virtual Actions</intervention_name>
    <description>If the patient is included in the group Performing Virtual Actions, he/she will be asked to perform Virtual Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to move around in a virtual environment for 10 minutes per day, once a day for 9 days.</description>
    <arm_group_label>Performing Virtual Actions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Haptic stimulation</intervention_name>
    <description>According to the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of step 4 in combination with haptic stimulation (sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.</description>
    <arm_group_label>Haptic stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Without haptic stimulation</intervention_name>
    <description>Without haptic stimulation Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of Step 4 in combination without haptic stimulation (without sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.</description>
    <arm_group_label>Without haptic stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For patients:&#xD;
&#xD;
          -  Step 1: Patient hospitalized in the Physical Medicine and Rehabilitation department of&#xD;
             the Rennes University Hospital following a stay in intensive care or in a Continuing&#xD;
             Care Unit, in particular following a COVID-19 infection, and with muscle weakness of&#xD;
             the lower limbs with an MRC motor testing on the main muscle segments giving a score&#xD;
             less than or equal to 48/60 (diagnostic criterion of ICU Weakness)&#xD;
&#xD;
          -  Steps 2 and 3: Patient hospitalized in one of the ICU of the Rennes University&#xD;
             Hospital and presenting post-resuscitation muscle weakness in the lower limbs with MRC&#xD;
             motor testing on the main muscle segments giving a score less than or equal to 48/60&#xD;
             (diagnostic criterion of ICU Weakness)&#xD;
&#xD;
          -  Steps 4 and 5: Patient hospitalized in one of the ICU or in the Physical Medicine and&#xD;
             Rehabilitation service of the Rennes University Hospital and presenting&#xD;
             post-resuscitation muscle weakness in the lower limbs with an MRC motor testing on the&#xD;
             main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion&#xD;
             of ICU-Weakness)&#xD;
&#xD;
        For nursing staff:&#xD;
&#xD;
        Step 2: Person with one of the following professions: nursing assistant, nurse, doctor,&#xD;
        physiotherapist, and practicing for more than a month in one of the ICU of the Rennes&#xD;
        University Hospital .&#xD;
&#xD;
        For everyone :&#xD;
&#xD;
          -  Person of full age;&#xD;
&#xD;
          -  Affiliation to a social security insurance;&#xD;
&#xD;
          -  Free, informed and written consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For patients:&#xD;
&#xD;
          -  History of central neurological event with clinical repercussions;&#xD;
&#xD;
          -  Gait disturbances preexisting in ICU hospitalization and limiting the gait perimeter&#xD;
             (declaration by the patient) or requiring the use of technical assistance;&#xD;
&#xD;
          -  Uncontrolled epilepsy (last crisis occurring less than 6 months old);&#xD;
&#xD;
          -  Persons of full age subject to legal protection (safeguard of justice, curators,&#xD;
             guardians), persons deprived of their liberty;&#xD;
&#xD;
          -  Pregnant or lactating woman.&#xD;
&#xD;
        For caregivers:&#xD;
&#xD;
          -  Non-French fluent people;&#xD;
&#xD;
          -  Adults over the age of legal protection (safeguard of justice, curators, guardians),&#xD;
             persons deprived of their liberty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <state>Bretagne</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Asthenia</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/NCT04441164
org study id: 35RC20_8897_VERARE
secondary id: 2020-A01722-37
nct id: NCT04441164
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually
      have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to
      treatments which had to be used. This disease is expected to be similar or even higher in
      patients suffering from COVID-19 and hospitalized in ICU due to the average length of
      hospitalization of several weeks in this population. This condition will delay the
      return-to-walk of these patients, their discharge from hospitalization and may deteriorate
      their autonomy in daily life activities.

      Virtual Reality (VR) environments are already used and have proven their worth for the
      assessment and rehabilitation of patients with neurological diseases. It therefore seems
      appropriate to offer the use of virtual environments for this type of population. VR
      represents a unique opportunity for the rehabilitation care of these patients, and in
      particular those who have been reached by COVID-19, due to the possible mismatch between the
      amount of motor rehabilitation to be provided and the fatigability and breathlessness at the
      slightest effort which seem particularly intense in this population.

      The main objective of our project is to improve and to accelerate gait recovery in patients
      hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or
      Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness
      secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual
      Reality tools. The VR tool will consist of virtual environments presented using a Virtual
      Reality headset where an avatar (double) of the patient hospitalized in Physical and
      Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks
      involving their lower limbs (ex: walking, or kicking a ball) in several different virtual
      environments (settings). The patient will be asked to observe actions, then to imagine
      carrying out their actions which will be performed by the avatar in the virtual environment,
      then they will be able to control the actions of the avatar using their legs thanks to
      sensors, then feel walking sensations through the use of haptic devices.
Step 1: The objective is to evaluate the effectiveness of the Observation of Virtual Actions
      on gait recovery in patients hospitalized in Physical and Rehabilitation Medicine (MPR) and
      presenting ICU-weakness, in particular following a COVID-19 infection. If the patient is
      included in the Virtual Reality group, they will be asked to observe once a day for 9 days
      for 5 minutes Virtual Motor Actions (avatar moving in a virtual environment) using a headset.
      Virtual Reality, followed by 5 minutes of relaxation performed using soothing music played
      through headphones. If the patient is included in the Relaxation group, they will be offered
      10 minutes of relaxation performed using soothing music played in headphones once a day for 9
      days. We will assess gait, motive power, balance, confidence in the future and patient
      autonomy before the start of the first session, the day after the last session and one month
      after inclusion. At the end of each session, we will ask the patient questions about fatigue
      (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality
      headset or headset. At the end of the 9 sessions, we will ask to patients in the Virtual
      Reality group to complete a questionnaire concerning the acceptance of the proposed device.
      We want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation
      group.

      Step 2: The objective is to assess the acceptability (a priori) of the Virtual Reality tool
      created in ICU by the nursing staff and by the patients who are hospitalized there. It will
      be offered to caregivers of the ICU of the Rennes University Hospital and to patients
      hospitalized in these 2 services and presenting ICU- weakness, especially in the aftermath of
      COVID infection. We will be asked to complete an acceptability questionnaire (a priori)
      concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The
      duration of filling in this questionnaire is estimated at 30 minutes. Caregivers will be
      invited to participate in an information meeting (4 will be carried out) at least 1 week
      before their possible participation (which they will be informed by internal mail, and which
      will be led by investigators). We believe that approximately 300 caregivers and 50 patients
      will participate in this acceptability survey.

      Step 3: The objective is to evaluate the effectiveness of the Observation of Virtual Actions
      on gait recovery in patients hospitalized in ICU and with ICU-weakness. If the acceptability
      questionnaire is in favor of a good future acceptance of the tool designed and after possible
      adaptations of the Virtual Reality device based on the responses of caregivers and patients
      to the acceptability questionnaire proposed during the step 2, we will suggest to patients
      hospitalized in ICU with ICU-weakness to carry out a protocol similar to that carried out
      with Physical and Rehabilitation Medicine patients in step 1. If the patient is included in
      the Virtual Reality group, they will be asked to observe once a day for 9 days for 5 minutes
      Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality
      headset, followed by 5 minutes of relaxation performed using soothing music played through
      headphones. If the patient is included in the Relaxation group, they will be offered 10
      minutes of relaxation performed using soothing music played in headphones once a day for 9
      days. We will assess gait, motive power, balance, confidence in the future and patient
      autonomy before the start of the first session, the day after the last session and 1 month
      after inclusion. At the end of each session, we will ask the patient questions about fatigue
      (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality
      headset. At the end of the 9 sessions, we will suggest to patients in the Virtual Reality
      group that they complete a questionnaire concerning the acceptance of the proposed device. We
      want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation
      group.

      Step 4: The objective is to assess the effectiveness of the realization of virtual actions
      compared to the observation of virtual actions on gait recovery in patients hospitalized in
      ICU or in Physical and Rehabilitation Medicine and presenting ICU-weakness. If the patient is
      included in the group Performing Virtual Actions, they will be asked to perform Virtual
      Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to
      move around in a virtual environment for 10 minutes per day, once a day for 9 days. If the
      patient is included in the Observation of Virtual Actions group, they will be asked to
      observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a
      virtual environment) using a Virtual Reality headset. We will assess gait, motive power,
      balance, confidence in the future and patient autonomy before the start of the first session,
      the day after the last session and 1 month after inclusion. At the end of each session, we
      will ask the patient questions about fatigue (VAS) and the occurrence of side effects (open
      question) after wearing the Virtual Reality headset. At the end of the 9 sessions, we will
      offer patients to fill out a questionnaire concerning the acceptance of the proposed device.
      We want to include 20 patients in the Virtual Actions group and 20 patients in the Virtual
      Actions Observation group.

      Step 5: The objective is to evaluate the effectiveness of adding a sensation of walking using
      haptic stimuli during the Observation or Realization of Virtual Actions on the recovery of
      walking in patients hospitalized in ICU or in Physical and Rehabilitation Medicine and with
      ICU-weakness. Depending on the superiority or not of the Realization of Virtual Actions or
      the Observation of Virtual Actions, we will test the most effective condition of step 4 in
      combination with: either haptic stimulation (sensory feedback through vibrators positioned on
      the lower limbs to give a feeling of walking), either without haptic stimulation, once a day
      for 10 minutes for 9 days. We will assess gait, motive power, balance, confidence in the
      future and patient autonomy before the start of the first session, the day after the last
      session and 1 month after inclusion. At the end of each session, we will ask the patient
      questions about fatigue (VAS) and the occurrence of side effects (open question) in the
      aftermath of wearing a Virtual Reality headset. At the end of the 9 sessions, we will offer
      patients to fill out a questionnaire concerning the acceptance of the proposed device. We
      want to include 20 patients in the group with haptic stimulation and 20 patients in the group
      without haptic stimulation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Step 1: 40 patients (20 in the Virtual Reality group and 20 in the Relaxation group)
Step 2: Estimated response rate of approximately 300 caregivers and 50 patients
Step 3: 40 patients (20 in the Virtual Reality group and 20 in the Relaxation group)
Step 4: 40 patients (20 in the group Performing Virtual Actions and 20 in the group Observing Virtual Actions)
Step 5: 40 patients (20 in the group with Haptic stimulation, 20 in the group without Haptic stimulation
primary purpose: Supportive Care
masking: None (Open Label)
measure: 6-minute test
time frame: Day 10
description: Number of meters taken during the 6-minute test the day after the last session.
measure: Time for 10-meter test
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 10-meter test (time in seconds)
measure: 6-minute walk test
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 6-minute walk test (need for breaks, scale de Borg, existence of desaturation)
measure: Recovery time
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: recovery time for walking over 10 meters without human or technical assistance
measure: Normal or deficient posture balance in sitting and standing
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: normal or deficient posture balance in sitting and standing
measure: Berg Balance Scale
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale. Berg's balance scale includes 14 tests that assess static balance and dynamic balance. Each test is rated from 0 (needs help) to 4 (can do on him/her own). Total score is on 56 points.
measure: Timed Up and Go test
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Timed Up and Go test (time in seconds)
measure: Duration for the test of the 10 chair lifts
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: test of the 10 chair lifts (duration in seconds, existence of a desaturation, Borg scale)
measure: MRC scale
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Strength assessment before the start of the first session, the day after the last session and within 1 month of inclusion: MRC testing of the lower limbs.
The Medical Research Council's scale (MRC scale) is an assessment of muscle power, rated form 0 (no contraction) to 5 (normal power).
measure: Functional Independence Measure
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of autonomy before the start of the first session, the day after the last session and within 1 month of inclusion: Functional Independence Measure.
The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory). Multiple studies support the reliability and validity of FIM scales in the older population.
measure: Acceptability
time frame: Day 1 (step 2)
description: Acceptability (a priori, patients and caregivers for stage 2) questionnaires
measure: Acceptance
time frame: Day 1 (step 2)
description: Acceptance (patients for stages 1, 3, 4 and 5) questionnaires
measure: Fatigue
time frame: End of each session, at days 1 to 9
description: Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)
measure: Undesirable effects
time frame: End of each session, at days 1 to 9
description: Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)
measure: Confidence in the future
time frame: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
description: Assessment of confidence in the future using a questionnaire (steps 1, 3, 4, 5) before the start of the first session, the day after the last session and 1 month from inclusion
arm group label: Observation of Virtual Actions (steps 1 and 3)
arm group type: Experimental
description: If the patient is included in the Virtual Reality group, he/she will be asked to observe Virtual Motor Actions (their own avatar moving in a virtual environment) using a headset once a day for 9 days during 5 minutes, followed by 5 minutes of relaxation performed using soothing music played through headphones.
arm group label: Relaxation
arm group type: Placebo Comparator
description: If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.
arm group label: Patients
arm group type: Other
description: It will be offered to patients hospitalized in these 2 services and presenting post-resuscitation ICU-weakness, especially in the aftermath of COVID infection, to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.
arm group label: Caregivers
arm group type: Other
description: It will be offered to caregivers of the ICU of the Rennes University Hospital, to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.
arm group label: Relaxation (step 3)
arm group type: Experimental
description: If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.
arm group label: Performing Virtual Actions
arm group type: Experimental
description: If the patient is included in the group Performing Virtual Actions, he/she will be asked to perform Virtual Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to move around in a virtual environment for 10 minutes per day, once a day for 9 days.
arm group label: Observation of Virtual Actions
arm group type: Placebo Comparator
description: If the patient is included in the Observation of Virtual Actions group, he/she will be asked to observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality headset.
arm group label: Haptic stimulation
arm group type: Experimental
description: Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of step 4 in combination with haptic stimulation (sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
arm group label: Without haptic stimulation
arm group type: Placebo Comparator
description: Without haptic stimulation Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of Step 4 in combination without haptic stimulation (without sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
intervention type: Other
intervention name: Observation of Virtual Actions
description: If the patient is included in the Virtual Reality group, he/she will be asked to observe Virtual Motor Actions (their own avatar moving in a virtual environment) using a headset once a day for 9 days during 5 minutes, followed by 5 minutes of relaxation performed using soothing music played through headphones.
arm group label: Observation of Virtual Actions (steps 1 and 3)
intervention type: Other
intervention name: Relaxation
description: If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.
arm group label: Relaxation
arm group label: Relaxation (step 3)
intervention type: Other
intervention name: Acceptability questionnaire
description: It will be asked to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.
arm group label: Caregivers
arm group label: Patients
intervention type: Other
intervention name: Observation of Virtual Actions (step 4)
description: If the patient is included in the Observation of Virtual Actions group, he/she will be asked to observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality headset.
arm group label: Observation of Virtual Actions
intervention type: Other
intervention name: Performing Virtual Actions
description: If the patient is included in the group Performing Virtual Actions, he/she will be asked to perform Virtual Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to move around in a virtual environment for 10 minutes per day, once a day for 9 days.
arm group label: Performing Virtual Actions
intervention type: Other
intervention name: Haptic stimulation
description: According to the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of step 4 in combination with haptic stimulation (sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
arm group label: Haptic stimulation
intervention type: Other
intervention name: Without haptic stimulation
description: Without haptic stimulation Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of Step 4 in combination without haptic stimulation (without sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
arm group label: Without haptic stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Paresis
mesh term: Asthenia
sharing ipd: No