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

NCT03646786 | Completed

• 1 other identifier: IDIL/2016/LJ-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Impairment

Outcome Measures

Primary Outcomes (25)

• dizziness felt by the patient

  Yes/no

  Day 0

• Nausea felt by the patient

  Yes/no

  Day 0

• headache felt by the patient

  Yes/no

  Day 0

• dazzle felt by the patient

  Yes/no

  Day 0

• watering of the patient

  Yes/no

  Day 0

• eye burns felt by the patient

  Yes/no

  Day 0

• Pain due to the mobilization of the eyeballs felt by the patient

  Yes/no

  Day 0

• Extraocular pain felt by the patient

  Yes/no

  Day 0

• diplopia

  Yes/no

  Day 0

• amaurosis

  Yes/no

  Day 0

• Fear

  Yes/no

  Day 0

• conformity of the session according to the patient point of view

  Yes/no

  Day 0

• unpleasantness of the session from the patient point of view

  Yes/no

  Day 0

• Difficulty of the session according to the patient point of view

  Yes/no

  Day 0

• Willingness to continue the following tests according to the patient point of view

  Yes/no

  Day 0

• Cervical pain felt by the patient

  Yes/no

  Day 0

• oculomotricity of the patient according to the therapist

  Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable

  Day 0

• head movements of the patient according to the therapist

  Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable

  Day 0

• body movements of the patient according to the therapist

  Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable

  Day 0

• target tracking by the patient according to the therapist

  0 = 0 target detected 1. 1 or 2 targets detected 2. 3 or 4 targets detected 3. 5 targets detected

  Day 0

• Time lapse to find targets

  minutes

  Day 0

• The patient asked for a pause during the test

  Yes/no

  Day 0

• The patient asked to permanently stop the tests

  Yes/no

  Day 0

• The patient went to the right place during the 3rd test

  Yes/no

  Day 0

• The patient has correctly performed the requested task

  Yes/no

  Day 0

Study Arms (1)

visually impaired patients

EXPERIMENTAL

Device: Virtual reality tests

Interventions

Virtual reality tests 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

visually impaired patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luc JEANJEAN

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: December 11, 2020
• Primary Completion: November 12, 2021
• Study Completion: March 11, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

FR (1)