ICU-weaknessVERARE_2NCT04713345
VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU-weakness
A study testing Virtual Reality Observations and Relaxation in people with ICU-weakness, run by Rennes University Hospital at 1 site in France.
Trial summary
After hospitalization in Intensive Care (Intensive Care Unit or Continuing Care Unit), approximately 50% of patients usually present with intensive ICU-weakness, i.e. damage to the nerves and muscles secondary to immobilization and to the treatments that must have been used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU-weakness
- What is being tested?
- Virtual Reality Observations and Relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2021to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized in one of the ICU or Continuing Care Units or at the CHU de Rennes for less than 3 months, and presenting lower limb muscle weakness with MRC motor testing on the main muscle segments giving a score of less than or equal to 48/60 (ICU Weakness diagnostic criterion) in the aftermath of severe sepsis.
- Person of full age;
- Affiliation to a social security scheme;
- Free, informed and signed written consent.
Who cannot join
- History of a central neurological event with clinical repercussions
- Gait disorders pre-existing to hospitalization in intensive care and limiting the walking perimeter (declaration by the patient) or requiring the use of technical assistance;
- Uncontrolled epilepsy (seizure less than 6 months old);
- Adults who are the subject of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty;
- Non-French speaking person;
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU Weakness
After hospitalization in Intensive Care (Intensive Care Unit or Continuing Care Unit), approximately 50% of patients usually present with intensive ICU-weakness, i.e. damage to the nerves and muscles secondary to immobilization and to the treatments that must have been used. This condition will delay the resumption of walking in these patients, their discharge from hospital and impair their autonomy in the daily life.
The recent international literature is in favor of early rehabilitative management of these patients, which should ideally be started in the intensive care unit. However, this is not always possible, due to the possible lack of physiotherapists in the services on the one hand, due to the fatigue of the population concerned and the existence of unstable medical conditions which do not always allow the use of recommended rehabilitation techniques on the other hand.
Read more
Virtual Reality (VR) environments are widely used for the assessment and rehabilitation of patients with neurological pathology. VR allows the user to be active in simulated activities and offers many advantages for the rehabilitation of motor functions in patients with neurological diseases. VR tools used to create action observation, motor imagery and sensations or even the illusion of movement in particular, have already shown their effectiveness in recovering and improving walking in different populations, especially after a stroke, in patients with Parkinson's Disease or Multiple Sclerosis. The role of the embodiment in VR appears promising in immersing participants in a controlled environment and creating movement's illusions.
The Virtual Reality tool designed consists of virtual environments presented using a Virtual Reality headset where an avatar (double) of the hospitalized patient will be represented, who will perform a walking motor task (involving his lower limbs ) in several different virtual environments (sets). In the present study named VERARE_2, the patient will be asked to observe walking actions and imagine performing them as they will be performed by the avatar in the virtual environment.
This VERARE_2 protocol aims to assess the effectiveness of the Observation of Virtual Motor Actions on the speed of gait recovery in hospitalized patients with IUC-weakness and in the intensive care units and continuing care units of the Rennes University Hospital.
- Conditions
- ICU-weakness
- Being tested
- Virtual Reality Observations, Relaxation
- Keywords
- resuscitation, ICU-weakness, virtual reality, avatar, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ObservationsOther
If the patient is included in the Virtual Reality group, they will be asked to observe 1 time per 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.
RelaxationOther
If the patient is included in the Relaxation group, they will be offered 10 minutes of relaxation performed using soothing music played through headphones once a day for 9 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | If the patient is included in the Virtual Reality group, they will be asked to observe 1 time per 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. Receives: Other: Virtual Reality Observations |
| Control group | Sham comparator | If the patient is included in the Relaxation group, they will be offered 10 minutes of relaxation performed using soothing music played through headphones once a day for 9 days. Receives: Other: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test
Number of meters taken during the 6-minute test the day after the last session
Measured: Day 9
Secondary outcomes (14)
10-meter walking test
Assessment of walking before the start of the first session, the day after the last session and 1 month after inclusion: 10-meter test (time in seconds)
Measured: Day1, day 9, month 1 and month 3
6-minute walking test
Assessment of walking before the start of the first session, the day after the last session and 1 month after inclusion: 6-minute walk test (need for breaks, scale of Borg, existence of a desaturation)
Measured: Day1, day 9, month 1 and month 3
Recovery time
Assessment of walking before the start of the first session, the day after the last session and 1 month after inclusion: recovery time of walking over 10 meters without human or technical assistance
Measured: Day 1, day 9, month 1 and month 3
Berg Balance Scale
Balance assessment before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale Berg's Balance Rating Scale consists of 14 tests that assess static and dynamic balance.
Static balance (standing without movement of the feet) is measured by the following tasks:
Feet glued together Unipodal support Tandem (one foot in front of the other) Eyes closed Trunk rotation
Dynamic balance is measured by the following tasks:
360º swivel Pick up an object Get up and sit down Seated transfer from one chair to another
All items except one are performed standing. They are rated on a 5-point ordinal scale (0-4) based on the ability to perform the movement or task independently, and criteria of time and distance. The total score varies between 0 and 56 points; a high score corresponds to a better balance [3, 4]. A score of 0 to 20 is associated with disturbed balance, 21 to 40 for acceptable balance and 41 to 56 for good balance.
Measured: Day 1, day 9, month 1 and month 3
Timed Up and Go test
Balance assessment 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: Day 1, day 9, month 1 and month 3
Test of the 10 chair lifts
Balance assessment 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: Day 1, day 9, month 1 and month 3
Strength
Strength assessment before the start of the first session, the day after the last session and 1 month after inclusion: MRC (Medical research council) testing of the lower limbs
0 No muscle contraction.
- Muscle contraction without movement.
- Movement in the plane of the bed.
- Movement against gravity.
- Movement against resistance.
- Normal muscle strength.
Measured: Day 1, day 9, month 1 and month 3
Force
3 manual dynamometer force measurements per upper limb
Measured: Day 1, day 9, month 1 and month 3
Autonomy
Assessment of autonomy before the start of the first session, the day after the last session and 1 month from inclusion using the FIM (Functional Independence Measure) FIM scores range from 1 to 7. The grading categories range from "total assistance with helper = 1" to "complete independence with no helper=7.
Measured: Day 1, day 9, month 1 and month 3
Confidence
Assessment of confidence in the future using a questionnaire before the start of the first session, the day after the last session, 1 month after inclusion and 3 months after inclusion.
Measured: Day 1, day 9, month 1 and month 3
Recovery time
Assessment of the recovery time from a possible 10-meter walk without human or technical assistance in this population (in days between the day of hospitalization in intensive care and the day of recovery from a possible 10-meter walk without human assistance neither technique, a criterion which is noted in the patient's medical file by his physiotherapist in current clinical practice)
Measured: Month 1
Acceptance
Acceptance questionnaire (established by the sponsor) : 54 items ranged from 1 to 7 (1 : not at all; 7 : completely) and 1 grade out of 10 and 1 to percentage
Measured: Day 9
Tiredness
Assessment of tiredness using a Visual Analogue Scale (VAS) from 0 = no fatigue to 7 = intense fatigue, at the end of each session with the Virtual Reality tool
Measured: Days 1, 2, 3, 4, 5, 6, 7 and 8
Rate of Adverse effects
Number of participants reporting any adverse effect during the intervention by open question at the end of each session with the Virtual Reality tool
Measured: Days 1, 2, 3, 4, 5, 6, 7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start26 Mar 2021
- Primary completion2 Jun 2025
- Study completion2 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU-weaknessStudies 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
- Pilot, single-center, prospective, randomized, open-label, superiority study with 2 parallel groups (1: 1): experimental group (Virtual Reality) versus control group (Relaxation).
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713345
- Sponsor's protocol ID
- 35RC20_3078_VERARE_2
- Other IDs
- 2020-A03462-37
- Acronym
- VERARE_2
- Status last verified
- Jun 2025
- First submitted
- 14 Dec 2020
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU Weakness
- ClinicalTrials.gov ID
- NCT04713345
- Acronym / sponsor ID
- VERARE_2 / 35RC20_3078_VERARE_2
- Conditions
- ICU-weakness
- Keywords
- resuscitation, ICU-weakness, virtual reality, avatar, rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 19 Jan 2021 (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 hospitalization in Intensive Care (Intensive Care Unit or Continuing Care Unit), approximately 50% of patients usually present with intensive ICU-weakness, i.e. damage to the nerves and muscles secondary to immobilization and to the treatments that must have been used. This condition will delay the resumption of walking in these patients, their discharge from hospital and impair their autonomy in the daily life.
The recent international literature is in favor of early rehabilitative management of these patients, which should ideally be started in the intensive care unit. However, this is not always possible, due to the possible lack of physiotherapists in the services on the one hand, due to the fatigue of the population concerned and the existence of unstable medical conditions which do not always allow the use of recommended rehabilitation techniques on the other hand.
Virtual Reality (VR) environments are widely used for the assessment and rehabilitation of patients with neurological pathology. VR allows the user to be active in simulated activities and offers many advantages for the rehabilitation of motor functions in patients with neurological diseases. VR tools used to create action observation, motor imagery and sensations or even the illusion of movement in particular, have already shown their effectiveness in recovering and improving walking in different populations, especially after a stroke, in patients with Parkinson's Disease or Multiple Sclerosis. The role of the embodiment in VR appears promising in immersing participants in a controlled environment and creating movement's illusions.
The Virtual Reality tool designed consists of virtual environments presented using a Virtual Reality headset where an avatar (double) of the hospitalized patient will be represented, who will perform a walking motor task (involving his lower limbs ) in several different virtual environments (sets). In the present study named VERARE_2, the patient will be asked to observe walking actions and imagine performing them as they will be performed by the avatar in the virtual environment.
This VERARE_2 protocol aims to assess the effectiveness of the Observation of Virtual Motor Actions on the speed of gait recovery in hospitalized patients with IUC-weakness and in the intensive care units and continuing care units of the Rennes University Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, single-center, prospective, randomized, open-label, superiority study with 2 parallel groups (1: 1): experimental group (Virtual Reality) versus control group (Relaxation).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual Reality ObservationsIf the patient is included in the Virtual Reality group, they will be asked to observe 1 time per 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. |
| Control group | Sham comparator | Other: RelaxationIf the patient is included in the Relaxation group, they will be offered 10 minutes of relaxation performed using soothing music played through headphones once a day for 9 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized in one of the ICU or Continuing Care Units or at the CHU de Rennes for less than 3 months, and presenting lower limb muscle weakness with MRC motor testing on the main muscle segments giving a score of less than or equal to 48/60 (ICU Weakness diagnostic criterion) in the aftermath of severe sepsis.
- Person of full age;
- Affiliation to a social security scheme;
- Free, informed and signed written consent.
Key exclusion criteria (6 listed)
- History of a central neurological event with clinical repercussions
- Gait disorders pre-existing to hospitalization in intensive care and limiting the walking perimeter (declaration by the patient) or requiring the use of technical assistance;
- Uncontrolled epilepsy (seizure less than 6 months old);
- Adults who are the subject of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty;
- Non-French speaking person;
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 |
|---|---|---|
| Virtual Reality ObservationsIf the patient is included in the Virtual Reality group, they will be asked to observe 1 time per 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. | Other | Experimental group |
| RelaxationIf the patient is included in the Relaxation group, they will be offered 10 minutes of relaxation performed using soothing music played through headphones once a day for 9 days. | Other | Control group |
Primary outcome
6-minute walking test
Time frame: Day 9
Number of meters taken during the 6-minute test the day after the last session
14 secondary outcomes
10-meter walking test
Time frame: Day1, day 9, month 1 and month 3
6-minute walking test
Time frame: Day1, day 9, month 1 and month 3
Recovery time
Time frame: Day 1, day 9, month 1 and month 3
Berg Balance Scale
Time frame: Day 1, day 9, month 1 and month 3
Timed Up and Go test
Time frame: Day 1, day 9, month 1 and month 3
Test of the 10 chair lifts
Time frame: Day 1, day 9, month 1 and month 3
Strength
Time frame: Day 1, day 9, month 1 and month 3
Force
Time frame: Day 1, day 9, month 1 and month 3
Autonomy
Time frame: Day 1, day 9, month 1 and month 3
Confidence
Time frame: Day 1, day 9, month 1 and month 3
Recovery time
Time frame: Month 1
Acceptance
Time frame: Day 9
Tiredness
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 8
Rate of Adverse effects
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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 Virtual Reality Observations and Relaxation in people with ICU-weakness, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 walking test (time frame: Day 9). 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 24 Jun 2025.