VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU-weakness

NCT04713345 | Active Not Recruiting

• 2 other identifiers: 35RC20_3078_VERARE_22020-A03462-37
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU-weakness

Keywords

resuscitation; ICU-weakness; virtual reality; avatar; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6-minute walking test

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

  Day 9

Secondary Outcomes (14)

• 10-meter walking test

  Day1, day 9, month 1 and month 3

• 6-minute walking test

  Day1, day 9, month 1 and month 3

• Recovery time

  Day 1, day 9, month 1 and month 3

• Berg Balance Scale

  Day 1, day 9, month 1 and month 3

• Timed Up and Go test

  Day 1, day 9, month 1 and month 3

Study Arms (2)

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.

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.

Other: Relaxation

Interventions

Virtual Reality Observations OTHER

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.

Experimental group

Relaxation OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France: collaborator

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35300, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, single-center, prospective, randomized, open-label, superiority study with 2 parallel groups (1: 1): experimental group (Virtual Reality) versus control group (Relaxation).

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 19, 2021
• Study Start: March 26, 2021
• Primary Completion: June 2, 2025
• Study Completion: September 2, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

FR (1)