Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441164
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
Institut National de Recherche en Informatique et en Automatique
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Weakness of the Lower Limbs Other: Observation of Virtual Actions Other: Relaxation Other: Acceptability questionnaire Other: Observation of Virtual Actions (step 4) Other: Performing Virtual Actions Other: Haptic stimulation Other: Without haptic stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
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
Official Title: VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2023

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 6-minute test [ Time Frame: Day 10 ]
    Number of meters taken during the 6-minute test the day after the last session.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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.

  6. 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)

  7. 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)

  8. 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).


  9. 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.


  10. Acceptability [ Time Frame: Day 1 (step 2) ]
    Acceptability (a priori, patients and caregivers for stage 2) questionnaires

  11. Acceptance [ Time Frame: Day 1 (step 2) ]
    Acceptance (patients for stages 1, 3, 4 and 5) questionnaires

  12. Fatigue [ Time Frame: End of each session, at days 1 to 9 ]
    Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)

  13. 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)

  14. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441164


Contacts
Layout table for location contacts
Contact: Mélanie COGNE, MD 02.99.28.42.18 melanie.cogne@chu-rennes.fr

Locations
Layout table for location information
France
Rennes University Hospital
Rennes, Bretagne, France, 35033
Contact: Mélanie COGNE, MD    02.99.28.42.18    melanie.cogne@chu-rennes.fr   
Principal Investigator: Mélanie COGNE, MD         
Sponsors and Collaborators
Rennes University Hospital
Institut National de Recherche en Informatique et en Automatique
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04441164    
Other Study ID Numbers: 35RC20_8897_VERARE
2020-A01722-37 ( Other Identifier: IDRCB )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes