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Clinical Trials/NCT04713345
NCT04713345
Active, not recruiting
Not Applicable

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

Rennes University Hospital1 site in 1 country68 target enrollmentMarch 26, 2021
ConditionsICU-weakness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICU-weakness
Sponsor
Rennes University Hospital
Enrollment
68
Locations
1
Primary Endpoint
6-minute walking test
Status
Active, not recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2021
End Date
September 2, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

6-minute walking test

Time Frame: Day 9

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

Secondary Outcomes

  • 6-minute walking test(Day1, day 9, month 1 and month 3)
  • Recovery time(Month 1)
  • Timed Up and Go test(Day 1, day 9, month 1 and month 3)
  • Test of the 10 chair lifts(Day 1, day 9, month 1 and month 3)
  • Tiredness(Days 1, 2, 3, 4, 5, 6, 7 and 8)
  • 10-meter walking test(Day1, day 9, month 1 and month 3)
  • Acceptance(Day 9)
  • Berg Balance Scale(Day 1, day 9, month 1 and month 3)
  • Strength(Day 1, day 9, month 1 and month 3)
  • Force(Day 1, day 9, month 1 and month 3)
  • Autonomy(Day 1, day 9, month 1 and month 3)
  • Confidence(Day 1, day 9, month 1 and month 3)
  • Rate of Adverse effects(Days 1, 2, 3, 4, 5, 6, 7 and 8)

Study Sites (1)

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