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

Primary Purpose

ICU-weakness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality Observations
Relaxation
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ICU-weakness focused on measuring resuscitation, ICU-weakness, virtual reality, avatar, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient hospitalized in one of the ICU departments or Continuing Medical or Surgical Care Units of the Rennes University Hospital for less than 3 months, and presenting muscle weakness of the lower limbs with a MRC motor test on the main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion of ICU Weakness)
  • 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.

Sites / Locations

  • Rennes University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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
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.
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)
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)
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.
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.
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)
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
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
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

Full Information

First Posted
December 14, 2020
Last Updated
November 8, 2022
Sponsor
Rennes University Hospital
Collaborators
Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France
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1. Study Identification

Unique Protocol Identification Number
NCT04713345
Brief Title
VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU-weakness
Acronym
VERARE_2
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
March 26, 2023 (Anticipated)
Study Completion Date
September 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Equipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes Cedex - France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU-weakness
Keywords
resuscitation, ICU-weakness, virtual reality, avatar, rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Observations
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walking test
Description
Number of meters taken during the 6-minute test the day after the last session
Time Frame
Day 9
Secondary Outcome Measure Information:
Title
10-meter walking test
Description
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)
Time Frame
Day1, day 9, month 1 and month 3
Title
6-minute walking test
Description
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)
Time Frame
Day1, day 9, month 1 and month 3
Title
Recovery time
Description
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
Time Frame
Day 1, day 9, month 1 and month 3
Title
Berg Balance Scale
Description
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.
Time Frame
Day 1, day 9, month 1 and month 3
Title
Timed Up and Go test
Description
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)
Time Frame
Day 1, day 9, month 1 and month 3
Title
Test of the 10 chair lifts
Description
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)
Time Frame
Day 1, day 9, month 1 and month 3
Title
Strength
Description
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.
Time Frame
Day 1, day 9, month 1 and month 3
Title
Autonomy
Description
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.
Time Frame
Day 1, day 9, month 1 and month 3
Title
Recovery time
Description
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)
Time Frame
Month 1
Title
Acceptance
Description
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
Time Frame
Day 9
Title
Tiredness
Description
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
Time Frame
Days 1, 2, 3, 4, 5, 6, 7 and 8
Title
Rate of Adverse effects
Description
Number of participants reporting any adverse effect during the intervention by open question at the end of each session with the Virtual Reality tool
Time Frame
Days 1, 2, 3, 4, 5, 6, 7 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient hospitalized in one of the ICU departments or Continuing Medical or Surgical Care Units of the Rennes University Hospital for less than 3 months, and presenting muscle weakness of the lower limbs with a MRC motor test on the main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion of ICU Weakness) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Cogné, MD
Phone
02.99.28.42.18
Email
melanie.cogne@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yoann Launey, MD
Phone
02.99.28.42.18
Email
yoann.launey@chu-rennes.fr
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie COGNE, MD
Email
melanie.cogne@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Isabelle BONAN, MD
Email
isabelle.bonan@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Mélanie COGNE, MD

12. IPD Sharing Statement

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

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