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

Primary Purpose

Stroke Rehabilitation, Postural Equilibrium

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)
Sponsored by
FondationbHopale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke Rehabilitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FONDATION HOPALE - Centre de rééducation Ste Barbe

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Random order of virtual scenes

Arm 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

Outcomes

Primary Outcome Measures

Total length of pressure center displacement (in mm)
Length of pressure will be recorded on a force platform under different conditions: Eyes open with VR headset simulating a static environment Eyes closed with VR helmet off In 8 VR conditions simulating movement (in random order)
Displacement speed of the center of pressure (in mm.s-1)
Displacement speed of the center of pressure will be recorded on a force platform under different conditions: Eyes open with VR headset simulating a static environment Eyes closed with VR helmet off In 8 VR conditions simulating movement (in random order)

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
September 22, 2023
Sponsor
FondationbHopale
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1. Study Identification

Unique Protocol Identification Number
NCT06053970
Brief Title
Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting
Acronym
VR-REACT
Official Title
Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FondationbHopale

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation, Postural Equilibrium

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Recruitment of twenty patients. The order of the virtual reality scenes will be randomly selected.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Random order of virtual scenes
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)
Intervention Description
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
Primary Outcome Measure Information:
Title
Total length of pressure center displacement (in mm)
Description
Length of pressure will be recorded on a force platform under different conditions: Eyes open with VR headset simulating a static environment Eyes closed with VR helmet off In 8 VR conditions simulating movement (in random order)
Time Frame
During the procedure (virtual reality session).
Title
Displacement speed of the center of pressure (in mm.s-1)
Description
Displacement speed of the center of pressure will be recorded on a force platform under different conditions: Eyes open with VR headset simulating a static environment Eyes closed with VR helmet off In 8 VR conditions simulating movement (in random order)
Time Frame
During the procedure (virtual reality session).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine Deseur
Phone
03 62 88 27 80
Email
marine.deseur@fondation-hopale.org
Facility Information:
Facility Name
FONDATION HOPALE - Centre de rééducation Ste Barbe
City
Fouquières-lès-Lens
ZIP/Postal Code
62740
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautier Saviard
Email
gautier.saviard@fondation-hopale.org

12. IPD Sharing Statement

Learn more about this trial

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

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