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

September 22, 2023 updated by: FondationbHopale

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of pressure center displacement (in mm)
Time Frame: During the procedure (virtual reality session).

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).
Displacement speed of the center of pressure (in mm.s-1)
Time Frame: During the procedure (virtual reality session).

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FondationbHopale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOP23-RIPH2-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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