Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients

Study Overview
=================
Brief Summary
-----------------
Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.

Official Title
-----------------
Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients

Conditions
-----------------
Visual Impairment

Intervention / Treatment
-----------------
* Device: Virtual reality tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient signed the consent form The patient is affiliated to a health insurance programme The patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...). The patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the Goldmann binocular visual field or homonymous hemianopia) of category I, II, III or IV of the WHO classification. Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by another study The patient is under safeguard of justice. The patient is under judicial protection. It is not possible to give the patient (or his/her trusted-person) informed information. The patient is pregnant or breastfeeding. The patient has a sensory or cognitive disability with a given scale (MMS < 24) The patient has difficulty moving including major locomotor difficulties.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: visually impaired patients<br> | Device: Virtual reality tests<br>* The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality: 10 minutes sitting test: detection of 5 targets in a 360 ° field of vision 10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dizziness felt by the patient | Yes/no | Day 0 | 
| Nausea felt by the patient | Yes/no | Day 0 | 
| headache felt by the patient | Yes/no | Day 0 | 
| dazzle felt by the patient | Yes/no | Day 0 | 
| watering of the patient | Yes/no | Day 0 | 
| eye burns felt by the patient | Yes/no | Day 0 | 
| Pain due to the mobilization of the eyeballs felt by the patient | Yes/no | Day 0 | 
| Extraocular pain felt by the patient | Yes/no | Day 0 | 
| diplopia | Yes/no | Day 0 | 
| amaurosis | Yes/no | Day 0 | 
| Fear | Yes/no | Day 0 | 
| conformity of the session according to the patient point of view | Yes/no | Day 0 | 
| unpleasantness of the session from the patient point of view | Yes/no | Day 0 | 
| Difficulty of the session according to the patient point of view | Yes/no | Day 0 | 
| Willingness to continue the following tests according to the patient point of view | Yes/no | Day 0 | 
| Cervical pain felt by the patient | Yes/no | Day 0 | 
| oculomotricity of the patient according to the therapist | Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable | Day 0 | 
| head movements of the patient according to the therapist | Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable | Day 0 | 
| body movements of the patient according to the therapist | Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable | Day 0 | 
| target tracking by the patient according to the therapist | 0 = 0 target detected 1 or 2 targets detected 3 or 4 targets detected 5 targets detected | Day 0 | 
| Time lapse to find targets | minutes | Day 0 | 
| The patient asked for a pause during the test | Yes/no | Day 0 | 
| The patient asked to permanently stop the tests | Yes/no | Day 0 | 
| The patient went to the right place during the 3rd test | Yes/no | Day 0 | 
| The patient has correctly performed the requested task | Yes/no | Day 0 |