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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)

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ClinicalTrials.gov Identifier: NCT03646786
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Visual Impairment Device: Virtual reality tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: visually impaired patients Device: 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




Primary Outcome Measures :
  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. 1 or 2 targets detected
    2. 3 or 4 targets detected
    3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or II 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.
  • The patient has difficulty moving.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646786


Contacts
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Contact: Luc JEANJEAN +33(0)4.66.68.36.84 luc.jeanjean@chu-nimes.fr

Locations
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France
Nimes University Hospital Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Luc JEANJEAN, Dr         
Sub-Investigator: Xavier Michel LUCAS         
Sub-Investigator: Fanny MACAES         
Sub-Investigator: Arnaud COLAVITTI         
Sub-Investigator: Nicolas Laurent         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Luc JEANJEAN Nîmes University Hospital

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03646786     History of Changes
Other Study ID Numbers: IDIL/2016/LJ-01
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms