Clinical trial NCT06053970: Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Postural Equilibrium
Lead sponsor: FondationbHopale
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Recruitment of twenty patients. The order of the virtual reality scenes will be randomly selected.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Total length of pressure center displacement (in mm)
timeFrame: During the procedure (virtual reality session).
measure: Displacement speed of the center of pressure (in mm.s-1)
timeFrame: During the procedure (virtual reality session).
Secondary outcomes:
Other outcomes:
Locations:
city: Fouquières-lès-Lens
country: France
facility: FONDATION HOPALE - Centre de rééducation Ste Barbe
Study officials:
References: