Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting

NCT ID: NCT06053970

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

Stroke Rehabilitation; Postural Equilibrium

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Random order of virtual scenes

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

Group Type: OTHER

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

Intervention Type: OTHER

The intervention will last 60 minutes and will include an assessment of the Berg Balance Scale (BBS), the collection of stabilometric data, the collection of the numerical difficulty scale, the Fast Motion Sickness Scale (FMS) and will end with a break after exposure to VR.

The various conditions will be carried out in this order:

• Eyes open with VR headset simulating a static environment
• Eyes closed with VR helmet off
• Eight measurements on a stabilometry platform will be taken for each of the VR signals, in random order

Interventions

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

The intervention will last 60 minutes and will include an assessment of the Berg Balance Scale (BBS), the collection of stabilometric data, the collection of the numerical difficulty scale, the Fast Motion Sickness Scale (FMS) and will end with a break after exposure to VR.

The various conditions will be carried out in this order:

• Eyes open with VR headset simulating a static environment
• Eyes closed with VR helmet off
• Eight measurements on a stabilometry platform will be taken for each of the VR signals, in random order

Intervention Type: OTHER

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FondationbHopale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

FONDATION HOPALE - Centre de rééducation Ste Barbe

Fouquières-lès-Lens, , France

Countries

France

Central Contacts

Marine Deseur

Role: CONTACT

marine.deseur@fondation-hopale.org

03 62 88 27 80

Facility Contacts

Gautier Saviard

Role: primary

gautier.saviard@fondation-hopale.org

Other Identifiers

HOP23-RIPH2-10

Identifier Type: -

Identifier Source: org_study_id