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

Stroke Rehabilitation Clinical Trial

— VR-REACT  

Official title:

Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053970
• Other study ID #: HOP23-RIPH2-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: FondationbHopale
• Contact: Marine Deseur
• Phone: 03 62 88 27 80
• Email: marine.deseur[@]fondation-hopale.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	FONDATION HOPALE - Centre de rééducation Ste Barbe	Fouquières-lès-Lens

Sponsors (1)

Lead Sponsor	Collaborator
FondationbHopale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	During the procedure (virtual reality session).
Primary	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)	During the procedure (virtual reality session).