Clinical trial NCT04713345: VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU-weakness
Official title: VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU Weakness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ICU-weakness
Keywords: resuscitation
ICU-weakness
virtual reality
avatar
rehabilitation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France
First posted: 2021-01-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 6-minute walking test
timeFrame: Day 9
Secondary outcomes:
measure: 10-meter walking test
timeFrame: Day1, day 9, month 1 and month 3
measure: 6-minute walking test
timeFrame: Day1, day 9, month 1 and month 3
measure: Recovery time
timeFrame: Day 1, day 9, month 1 and month 3
measure: Berg Balance Scale
timeFrame: Day 1, day 9, month 1 and month 3
measure: Timed Up and Go test
timeFrame: Day 1, day 9, month 1 and month 3
measure: Test of the 10 chair lifts
timeFrame: Day 1, day 9, month 1 and month 3
measure: Strength
timeFrame: Day 1, day 9, month 1 and month 3
measure: Force
timeFrame: Day 1, day 9, month 1 and month 3
measure: Autonomy
timeFrame: Day 1, day 9, month 1 and month 3
measure: Confidence
timeFrame: Day 1, day 9, month 1 and month 3
measure: Recovery time
timeFrame: Month 1
measure: Acceptance
timeFrame: Day 9
measure: Tiredness
timeFrame: Days 1, 2, 3, 4, 5, 6, 7 and 8
measure: Rate of Adverse effects
timeFrame: Days 1, 2, 3, 4, 5, 6, 7 and 8
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
Study officials:
References: