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Completed

NCT Number: NCT03646786

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

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.

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Key information

Conditions

Visual Impairment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality tests

Device

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 outcomes

  1. dizziness felt by the patient

    Time frame: Day 0

    Yes/no

  2. Nausea felt by the patient

    Time frame: Day 0

    Yes/no

  3. headache felt by the patient

    Time frame: Day 0

    Yes/no

  4. dazzle felt by the patient

    Time frame: Day 0

    Yes/no

  5. watering of the patient

    Time frame: Day 0

    Yes/no

  6. eye burns felt by the patient

    Time frame: Day 0

    Yes/no

  7. Pain due to the mobilization of the eyeballs felt by the patient

    Time frame: Day 0

    Yes/no

  8. Extraocular pain felt by the patient

    Time frame: Day 0

    Yes/no

  9. diplopia

    Time frame: Day 0

    Yes/no

  10. amaurosis

    Time frame: Day 0

    Yes/no

  11. Fear

    Time frame: Day 0

    Yes/no

  12. conformity of the session according to the patient point of view

    Time frame: Day 0

    Yes/no

  13. unpleasantness of the session from the patient point of view

    Time frame: Day 0

    Yes/no

  14. Difficulty of the session according to the patient point of view

    Time frame: Day 0

    Yes/no

  15. Willingness to continue the following tests according to the patient point of view

    Time frame: Day 0

    Yes/no

  16. Cervical pain felt by the patient

    Time frame: Day 0

    Yes/no

  17. oculomotricity of the patient according to the therapist

    Time frame: Day 0

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

  18. head movements of the patient according to the therapist

    Time frame: Day 0

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

  19. body movements of the patient according to the therapist

    Time frame: Day 0

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

  20. target tracking by the patient according to the therapist

    Time frame: Day 0

    0 = 0 target detected

    • 1 or 2 targets detected
    • 3 or 4 targets detected
    • 5 targets detected

  21. Time lapse to find targets

    Time frame: Day 0

    minutes

  22. The patient asked for a pause during the test

    Time frame: Day 0

    Yes/no

  23. The patient asked to permanently stop the tests

    Time frame: Day 0

    Yes/no

  24. The patient went to the right place during the 3rd test

    Time frame: Day 0

    Yes/no

  25. The patient has correctly performed the requested task

    Time frame: Day 0

    Yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: VIRARE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 24, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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