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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03646786
Acronym
VIRARE
Enrollment
30
Registered
2018-08-24
Start date
2020-12-11
Completion date
2022-03-11
Last updated
2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Impairment

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.

Interventions

DEVICEVirtual reality tests

The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality: 1. 10 minutes sitting test: detection of 5 targets in a 360 ° field of vision 2. 10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe 3. 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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
dizziness felt by the patientDay 0Yes/no
Nausea felt by the patientDay 0Yes/no
headache felt by the patientDay 0Yes/no
dazzle felt by the patientDay 0Yes/no
watering of the patientDay 0Yes/no
eye burns felt by the patientDay 0Yes/no
Pain due to the mobilization of the eyeballs felt by the patientDay 0Yes/no
Extraocular pain felt by the patientDay 0Yes/no
diplopiaDay 0Yes/no
amaurosisDay 0Yes/no
FearDay 0Yes/no
conformity of the session according to the patient point of viewDay 0Yes/no
unpleasantness of the session from the patient point of viewDay 0Yes/no
Difficulty of the session according to the patient point of viewDay 0Yes/no
Willingness to continue the following tests according to the patient point of viewDay 0Yes/no
Cervical pain felt by the patientDay 0Yes/no
oculomotricity of the patient according to the therapistDay 0Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
head movements of the patient according to the therapistDay 0Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
body movements of the patient according to the therapistDay 0Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
target tracking by the patient according to the therapistDay 00 = 0 target detected 1. 1 or 2 targets detected 2. 3 or 4 targets detected 3. 5 targets detected
Time lapse to find targetsDay 0minutes
The patient asked for a pause during the testDay 0Yes/no
The patient asked to permanently stop the testsDay 0Yes/no
The patient went to the right place during the 3rd testDay 0Yes/no
The patient has correctly performed the requested taskDay 0Yes/no

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026