Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The patient has correctly performed the requested task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The patient has correctly performed the requested task
时间窗: Day 0
Yes/no
Difficulty of the session according to the patient point of view
时间窗: Day 0
Yes/no
dizziness felt by the patient
时间窗: Day 0
Yes/no
Nausea felt by the patient
时间窗: Day 0
Yes/no
Fear
时间窗: Day 0
Yes/no
Willingness to continue the following tests according to the patient point of view
时间窗: Day 0
Yes/no
head movements of the patient according to the therapist
时间窗: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Time lapse to find targets
时间窗: Day 0
minutes
headache felt by the patient
时间窗: Day 0
Yes/no
Extraocular pain felt by the patient
时间窗: Day 0
Yes/no
diplopia
时间窗: Day 0
Yes/no
oculomotricity of the patient according to the therapist
时间窗: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Cervical pain felt by the patient
时间窗: Day 0
Yes/no
body movements of the patient according to the therapist
时间窗: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
target tracking by the patient according to the therapist
时间窗: Day 0
0 = 0 target detected 1. 1 or 2 targets detected 2. 3 or 4 targets detected 3. 5 targets detected
The patient asked for a pause during the test
时间窗: Day 0
Yes/no
The patient went to the right place during the 3rd test
时间窗: Day 0
Yes/no
watering of the patient
时间窗: Day 0
Yes/no
eye burns felt by the patient
时间窗: Day 0
Yes/no
amaurosis
时间窗: Day 0
Yes/no
unpleasantness of the session from the patient point of view
时间窗: Day 0
Yes/no
The patient asked to permanently stop the tests
时间窗: Day 0
Yes/no
dazzle felt by the patient
时间窗: Day 0
Yes/no
Pain due to the mobilization of the eyeballs felt by the patient
时间窗: Day 0
Yes/no
conformity of the session according to the patient point of view
时间窗: Day 0
Yes/no
次要结局
未报告次要终点