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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03646786
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment	Device: Virtual reality tests	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Dec 11, 2020
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures

1. dizziness felt by the patient [Day 0]

   Yes/no

2. Nausea felt by the patient [Day 0]

   Yes/no

3. headache felt by the patient [Day 0]

   Yes/no

4. dazzle felt by the patient [Day 0]

   Yes/no

5. watering of the patient [Day 0]

   Yes/no

6. eye burns felt by the patient [Day 0]

   Yes/no

7. Pain due to the mobilization of the eyeballs felt by the patient [Day 0]

   Yes/no

8. Extraocular pain felt by the patient [Day 0]

   Yes/no

9. diplopia [Day 0]

   Yes/no

10. amaurosis [Day 0]

    Yes/no

11. Fear [Day 0]

    Yes/no

12. conformity of the session according to the patient point of view [Day 0]

    Yes/no

13. unpleasantness of the session from the patient point of view [Day 0]

    Yes/no

14. Difficulty of the session according to the patient point of view [Day 0]

    Yes/no

15. Willingness to continue the following tests according to the patient point of view [Day 0]

    Yes/no

16. Cervical pain felt by the patient [Day 0]

    Yes/no

17. oculomotricity of the patient according to the therapist [Day 0]

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

18. head movements of the patient according to the therapist [Day 0]

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

19. body movements of the patient according to the therapist [Day 0]

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

20. target tracking by the patient according to the therapist [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 [Day 0]

    minutes

22. The patient asked for a pause during the test [Day 0]

    Yes/no

23. The patient asked to permanently stop the tests [Day 0]

    Yes/no

24. The patient went to the right place during the 3rd test [Day 0]

    Yes/no

25. The patient has correctly performed the requested task [Day 0]

    Yes/no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nimes University Hospital	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Luc JEANJEAN, Nîmes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03646786
• Other Study ID Numbers: IDIL/2016/LJ-01
• First Posted: Aug 24, 2018
• Last Update Posted: Dec 27, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vision Disorders; Vision, Low

Study Results

No Results Posted as of Dec 27, 2021