Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting (VR-REACT)

FondationbHopale

Status: Not yet enrolling

Conditions: Stroke Rehabilitation; Postural Equilibrium

Treatments: Other: Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06053970

HOP23-RIPH2-10

Details and patient eligibility

About

This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.

Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.

The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.

This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.

During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age: over 18
• Adult patient in rehabilitation stay (day or full hospitalization) following a first stroke less than 6 months old.
• One of the rehabilitation objectives is to improve balance
• Ability to understand exercise instructions
• Ability to stand for at least one minute with eyes closed, safely and without technical assistance
• Ability to walk at least with technical assistance and/or supervision
• Patient having given their informed consent
• Patient affiliated to a social security scheme

Non -inclusion criteria :

• Patients with epilepsy, controlled or not
• Patients undergoing rehabilitation following a stroke in the posterior fossa
• Known history of vestibular or cerebellar balance disorders
• Patients with orthopedic or traumatological impairment preventing stabilometric measurement on a force platform without footwear
• Patient under legal protection measure
• Severe phasic disorders that may prevent the expression of the will to stop viewing virtual scenes or to respond to numerical scales
• Pregnant or breastfeeding woman
• Known history of motion sickness
• Patient participating or having participated in the balance rehabilitation program with virtual reality within the rehabilitation center during their stay

Exclusion Criteria :

• Cyberkinetosis represented by a score greater than or equal to 15 on the Fast Motion Sickness scale
• Poor tolerance for wearing a virtual reality headset
• Significant visual impairment preventing the perception of the stimulus visual

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Random order of virtual scenes

Other group

Description:

Eight measurements on a stabilometry platform will be performed for each of the VR signals, in random order: Signal A Direction: anteroposterior Speed: 5 m/s Signal B Direction: anterior-posterior Speed: 5 m/s Signal C Direction: Oblique forward and downward Speed: 5 m/s Signal D Direction: Oblique forwards and upwards Speed: 5 m/s Signal E Direction: Oblique forwards and to the right Speed: 5 m/s Signal F Direction: Oblique forward and left Speed: 5 m/s Signal G Direction: antero-posterior + Clockwise tunnel rotation at 10°/s Speed: 5 m/s Signal H Direction: antero-posterior + Counter-clockwise tunnel rotation at 10°/s Speed: 5 m/s

Treatment:

Other: Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)