Weakness of the Lower LimbsVERARENCT04441164
VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
A study testing Observation of Virtual Actions, Relaxation and Acceptability questionnaire in people with Weakness of the Lower Limbs, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weakness of the Lower Limbs
- What is being tested?
- Observation of Virtual Actions, Relaxation and Acceptability questionnaire
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
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- For everyone :
- Person of full age;
- Affiliation to a social security insurance;
- Free, informed and written consent signed.
Who cannot join
- 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.
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- For caregivers:
- Non-French fluent people;
- Adults over the age of legal protection (safeguard of justice, curators, guardians), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Weakness of the Lower Limbs
- Being tested
- Observation of Virtual Actions, Relaxation, Acceptability questionnaire, Observation of Virtual Actions (step 4), Performing Virtual Actions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of Virtual ActionsOther
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.
RelaxationOther
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.
Acceptability questionnaireOther
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.
Observation of Virtual Actions (step 4)Other
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.
Performing Virtual ActionsOther
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.
Haptic stimulationOther
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.
Without haptic stimulationOther
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 group | Role | What they receive |
|---|---|---|
| Observation of Virtual Actions (steps 1 and 3) | Experimental | 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. Receives: Other: Observation of Virtual Actions |
| Relaxation | Placebo comparator | 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. Receives: Other: Relaxation |
| Patients | Other | 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. Receives: Other: Acceptability questionnaire |
| Caregivers | Other | 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. Receives: Other: Acceptability questionnaire |
| Relaxation (step 3) | Experimental | 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. Receives: Other: Relaxation |
| Performing Virtual Actions | Experimental | 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. Receives: Other: Performing Virtual Actions |
| Observation of Virtual Actions | Placebo comparator | 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. Receives: Other: Observation of Virtual Actions (step 4) |
| Haptic stimulation | Experimental | 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. Receives: Other: Haptic stimulation |
| Without haptic stimulation | Placebo comparator | 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. Receives: Other: Without haptic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute test
Number of meters taken during the 6-minute test the day after the last session.
Measured: Day 10
Secondary outcomes (14)
Time for 10-meter test
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)
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
6-minute walk test
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)
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Recovery time
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
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Normal or deficient posture balance in sitting and standing
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
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Berg Balance Scale
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.
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Timed Up and Go test
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)
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Duration for the test of the 10 chair lifts
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)
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
MRC scale
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).
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Functional Independence Measure
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.
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Acceptability
Acceptability (a priori, patients and caregivers for stage 2) questionnaires
Measured: Day 1 (step 2)
Acceptance
Acceptance (patients for stages 1, 3, 4 and 5) questionnaires
Measured: Day 1 (step 2)
Fatigue
Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)
Measured: End of each session, at days 1 to 9
Undesirable effects
Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)
Measured: End of each session, at days 1 to 9
Confidence in the future
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
Measured: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Why it stopped: Submitted, denied (too much steps; project to be cut in several projects)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weakness of the Lower LimbsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441164
- Sponsor's protocol ID
- 35RC20_8897_VERARE
- Other IDs
- 2020-A01722-37
- Acronym
- VERARE
- Status last verified
- Jan 2021
- First submitted
- 16 Jun 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness
- ClinicalTrials.gov ID
- NCT04441164
- Acronym / sponsor ID
- VERARE / 35RC20_8897_VERARE
- Conditions
- Weakness of the Lower Limbs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Submitted, denied (too much steps; project to be cut in several projects)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- 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
| Arm | Type | Receives |
|---|---|---|
| Observation of Virtual Actions (steps 1 and 3) | Experimental | Other: Observation of Virtual ActionsIf 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. |
| Relaxation | Placebo comparator | Other: RelaxationIf 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 | Other | Other: Acceptability questionnaireIt 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. |
| Caregivers | Other | Other: Acceptability questionnaireIt 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. |
| Relaxation (step 3) | Experimental | Other: RelaxationIf 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. |
| Performing Virtual Actions | Experimental | Other: Performing Virtual ActionsIf 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. |
| Observation of Virtual Actions | Placebo comparator | 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. |
| Haptic stimulation | Experimental | Other: Haptic stimulationDepending 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. |
| Without haptic stimulation | Placebo comparator | Other: Without haptic stimulationWithout 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- 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 .
- Person of full age;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of Virtual ActionsIf 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 (steps 1 and 3) |
| RelaxationIf 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, Relaxation (step 3) |
| Acceptability questionnaireIt 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 | Caregivers, Patients |
| 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 | Observation of Virtual Actions |
| Performing Virtual ActionsIf 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 |
| Haptic stimulationAccording 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 | Haptic stimulation |
| Without haptic stimulationWithout 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 |
Primary outcome
6-minute test
Time frame: Day 10
Number of meters taken during the 6-minute test the day after the last session.
14 secondary outcomes
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
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
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
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
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
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
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
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
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
Acceptability
Time frame: Day 1 (step 2)
Acceptance
Time frame: Day 1 (step 2)
Fatigue
Time frame: End of each session, at days 1 to 9
Undesirable effects
Time frame: End of each session, at days 1 to 9
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation of Virtual Actions, Relaxation and Acceptability questionnaire in people with Weakness of the Lower Limbs, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute test (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.