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

Visual Impairment Clinical Trial

— VIRARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646786
• Other study ID #: IDIL/2016/LJ-01
• Status: Completed
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: March 11, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 11, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• Virtual reality tests
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

Locations

Country	Name	City	State
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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