VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
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.
Inclusion Criteria:

 For patients:

 -  Step 1: Patient hospitalized in the Physical Medicine and Rehabilitation department of
 the Rennes University Hospital following a stay in intensive care or in a Continuing
 Care Unit, in particular following a COVID-19 infection, and with muscle weakness of
 the lower limbs with an MRC motor testing on the main muscle segments giving a score
 less than or equal to 48/60 (diagnostic criterion of ICU Weakness)

 -  Steps 2 and 3: Patient hospitalized in one of the ICU of the Rennes University
 Hospital and presenting post-resuscitation muscle weakness in the lower limbs with MRC
 motor testing on the main muscle segments giving a score less than or equal to 48/60
 (diagnostic criterion of ICU Weakness)

 -  Steps 4 and 5: Patient hospitalized in one of the ICU or in the Physical Medicine and
 Rehabilitation service of the Rennes University Hospital and presenting
 post-resuscitation muscle weakness in the lower limbs with an MRC motor testing on the
 main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion
 of ICU-Weakness)

 For nursing staff:

 Step 2: Person with one of the following professions: nursing assistant, nurse, doctor,
 physiotherapist, and practicing for more than a month in one of the ICU of the Rennes
 University Hospital .

 For everyone :

 -  Person of full age;

 -  Affiliation to a social security insurance;

 -  Free, informed and written consent signed.

 Exclusion Criteria:

 For patients:

 -  History of central neurological event with clinical repercussions;

 -  Gait disturbances preexisting in ICU hospitalization and limiting the gait perimeter
 (declaration by the patient) or requiring the use of technical assistance;

 -  Uncontrolled epilepsy (last crisis occurring less than 6 months old);

 -  Persons of full age subject to legal protection (safeguard of justice, curators,
 guardians), persons deprived of their liberty;

 -  Pregnant or lactating woman.

 For caregivers:

 -  Non-French fluent people;

 -  Adults over the age of legal protection (safeguard of justice, curators, guardians),
 persons deprived of their liberty.