VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness (VERARE)

• ClinicalTrials.gov Identifier: NCT04441164
• Recruitment Status: Withdrawn
• First Posted: June 22, 2020
• Last Update Posted: January 6, 2021
• Sponsor: Rennes University Hospital
• Collaborator: Institut National de Recherche en Informatique et en Automatique
• Information provided by (Responsible Party): Rennes University Hospital

Tracking Information

• First Submitted Date: June 16, 2020
• First Posted Date: June 22, 2020
• Last Update Posted Date: January 6, 2021
• Estimated Study Start Date: August 1, 2020
• Estimated Primary Completion Date: August 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2020)

6-minute test [ Time Frame: Day 10 ]

Number of meters taken during the 6-minute test the day after the last session.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 18, 2020)

• 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 ]
  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)
• 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 ]
  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)
• 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 ]
  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
• 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 ]
  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
• 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 ]
  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.
• 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 ]
  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)
• 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 ]
  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)
• 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 ]
  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).
• 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 ]
  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.
• Acceptability [ Time Frame: Day 1 (step 2) ]
  Acceptability (a priori, patients and caregivers for stage 2) questionnaires
• Acceptance [ Time Frame: Day 1 (step 2) ]
  Acceptance (patients for stages 1, 3, 4 and 5) questionnaires
• Fatigue [ Time Frame: End of each session, at days 1 to 9 ]
  Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)
• Undesirable effects [ Time Frame: End of each session, at days 1 to 9 ]
  Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)
• 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 ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
• Official Title: VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness

Brief Summary

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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Weakness of the Lower Limbs

Intervention

• Other: Observation of Virtual Actions
  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.
• Other: Relaxation
  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.
• Other: Acceptability questionnaire
  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.
• Other: Observation of Virtual Actions (step 4)
  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.
• Other: Performing Virtual Actions
  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.
• Other: Haptic stimulation
  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.
• Other: Without haptic stimulation
  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.

Study Arms

• Experimental: Observation of Virtual Actions (steps 1 and 3)
  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.
  Intervention: Other: Observation of Virtual Actions
• Placebo Comparator: Relaxation
  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.
  Intervention: Other: Relaxation
• Patients
  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.
  Intervention: Other: Acceptability questionnaire
• Caregivers
  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.
  Intervention: Other: Acceptability questionnaire
• Experimental: Relaxation (step 3)
  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.
  Intervention: Other: Relaxation
• Experimental: Performing Virtual Actions
  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.
  Intervention: Other: Performing Virtual Actions
• Placebo Comparator: Observation of Virtual Actions
  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.
  Intervention: Other: Observation of Virtual Actions (step 4)
• Experimental: 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 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.
  Intervention: Other: Haptic stimulation
• Placebo Comparator: Without haptic stimulation
  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: Other: Without haptic stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 5, 2021): 0
• Original Estimated Enrollment (submitted: June 18, 2020): 510
• Estimated Study Completion Date: August 1, 2023
• Estimated Primary Completion Date: August 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04441164
• Other Study ID Numbers: 35RC20_8897_VERARE; 2020-A01722-37 ( Other Identifier: IDRCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Rennes University Hospital
• Study Sponsor: Rennes University Hospital
• Collaborators: Institut National de Recherche en Informatique et en Automatique
• Investigators: Not Provided
• PRS Account: Rennes University Hospital
• Verification Date: January 2021