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

Not Applicable

Completed

• Conditions: Visual Impairment

• Registration Number: NCT03646786
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2020-12-11
• Primary Completion: 2021-11-12
• Study Completion: 2022-03-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nimes University Hospital; 🇫🇷 Nîmes, France