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

Primary Purpose

Visual Impairment

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality tests
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Visual Impairment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nimes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

visually impaired patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2018
Last Updated
September 27, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03646786
Brief Title
Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
Acronym
VIRARE
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
visually impaired patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual reality tests
Intervention Description
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
Primary Outcome Measure Information:
Title
dizziness felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
Nausea felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
headache felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
dazzle felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
watering of the patient
Description
Yes/no
Time Frame
Day 0
Title
eye burns felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
Pain due to the mobilization of the eyeballs felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
Extraocular pain felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
diplopia
Description
Yes/no
Time Frame
Day 0
Title
amaurosis
Description
Yes/no
Time Frame
Day 0
Title
Fear
Description
Yes/no
Time Frame
Day 0
Title
conformity of the session according to the patient point of view
Description
Yes/no
Time Frame
Day 0
Title
unpleasantness of the session from the patient point of view
Description
Yes/no
Time Frame
Day 0
Title
Difficulty of the session according to the patient point of view
Description
Yes/no
Time Frame
Day 0
Title
Willingness to continue the following tests according to the patient point of view
Description
Yes/no
Time Frame
Day 0
Title
Cervical pain felt by the patient
Description
Yes/no
Time Frame
Day 0
Title
oculomotricity of the patient according to the therapist
Description
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Time Frame
Day 0
Title
head movements of the patient according to the therapist
Description
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Time Frame
Day 0
Title
body movements of the patient according to the therapist
Description
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Time Frame
Day 0
Title
target tracking by the patient according to the therapist
Description
0 = 0 target detected 1 or 2 targets detected 3 or 4 targets detected 5 targets detected
Time Frame
Day 0
Title
Time lapse to find targets
Description
minutes
Time Frame
Day 0
Title
The patient asked for a pause during the test
Description
Yes/no
Time Frame
Day 0
Title
The patient asked to permanently stop the tests
Description
Yes/no
Time Frame
Day 0
Title
The patient went to the right place during the 3rd test
Description
Yes/no
Time Frame
Day 0
Title
The patient has correctly performed the requested task
Description
Yes/no
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JEANJEAN
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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