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

NCT ID: NCT03646786

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2022-03-11

Brief Summary

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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

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Conditions

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Visual Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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visually impaired patients

Group Type EXPERIMENTAL

Virtual reality tests

Intervention Type DEVICE

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

Interventions

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Virtual 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc JEANJEAN

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

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Nimes University Hospital

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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IDIL/2016/LJ-01

Identifier Type: -

Identifier Source: org_study_id

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