NCT04441164: VERARE

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

Withdrawn NA Last updated 6 January 2021

What this trial tests

NA trial testing Observation of Virtual Actions in Weakness of the Lower Limbs. Withdrawn.

Timeline

1 August 2020

Primary endpoint
1 August 2022

1 August 2023

Quick facts

Lead sponsor	Rennes University Hospital
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Start date	1 August 2020
Primary completion	1 August 2022
Estimated completion	1 August 2023
Sites	1 location across France

Drugs / interventions tested

• Observation of Virtual Actions
• Relaxation
• Acceptability questionnaire
• Observation of Virtual Actions (step 4)
• Performing Virtual Actions
• Haptic stimulation
• Without haptic stimulation

Conditions studied

• Weakness of the Lower Limbs — all drugs for Weakness of the Lower Limbs →

Sponsor

Rennes University Hospital

Who can join

18 and older, any sex, with Weakness of the Lower Limbs. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.