Clinical trial NCT03646786: Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
Official title: Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: dizziness felt by the patient
timeFrame: Day 0
measure: Nausea felt by the patient
timeFrame: Day 0
measure: headache felt by the patient
timeFrame: Day 0
measure: dazzle felt by the patient
timeFrame: Day 0
measure: watering of the patient
timeFrame: Day 0
measure: eye burns felt by the patient
timeFrame: Day 0
measure: Pain due to the mobilization of the eyeballs felt by the patient
timeFrame: Day 0
measure: Extraocular pain felt by the patient
timeFrame: Day 0
measure: diplopia
timeFrame: Day 0
measure: amaurosis
timeFrame: Day 0
measure: Fear
timeFrame: Day 0
measure: conformity of the session according to the patient point of view
timeFrame: Day 0
measure: unpleasantness of the session from the patient point of view
timeFrame: Day 0
measure: Difficulty of the session according to the patient point of view
timeFrame: Day 0
measure: Willingness to continue the following tests according to the patient point of view
timeFrame: Day 0
measure: Cervical pain felt by the patient
timeFrame: Day 0
measure: oculomotricity of the patient according to the therapist
timeFrame: Day 0
measure: head movements of the patient according to the therapist
timeFrame: Day 0
measure: body movements of the patient according to the therapist
timeFrame: Day 0
measure: target tracking by the patient according to the therapist
timeFrame: Day 0
measure: Time lapse to find targets
timeFrame: Day 0
measure: The patient asked for a pause during the test
timeFrame: Day 0
measure: The patient asked to permanently stop the tests
timeFrame: Day 0
measure: The patient went to the right place during the 3rd test
timeFrame: Day 0
measure: The patient has correctly performed the requested task
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
affiliation: Nîmes University Hospital
name: Luc JEANJEAN
role: PRINCIPAL_INVESTIGATOR
References: