Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Visual field perimetry measured using the Esterman binocular field test
研究概览
简要总结
Evaluate the efficiency of audiovisual stimulation in virtual reality for improving the visual perception of children, adolescents, and young adults with hemianopia resulting from pediatric brain tumors. These individuals can lose up to 50% of their visual field, significantly impacting their independence, mobility, and daily lives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •10 - 40 years old
- •Diagnosed hemianopsia (>12 months)
- •History of diagnosis brain tumour
- •Being stable for the tumour for > 6 months (either on therapy or not)
- •Visual acuity ≤ 0.7 LogMAR
- •Ability to follow the visual and auditory stimuli and training instructions
- •Home WiFi access
- •Ability to attend all on site visits
- •Affiliation to the Social Security or beneficiary of such social protection
排除标准
- •Age< 10 years old of > 40 years old
- •Ocular disease
- •Inability to perform during testing or training
- •3 consecutive VRISE scores < 25 at inclusion
- •History of vertigo
- •Prior vision rehabilitation interventions
- •Recreational or medicinal consumption of psychoactive drugs
- •Persons under court protection
- •Interpupillary distance < 54mm
研究组 & 干预措施
Control
Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks
干预措施: standard of care (Other)
Intervention
Visual stimulation for the first 8 weeks then standard of care for the following 8 weeks
干预措施: Visual Stimulation (Device)
Intervention
Visual stimulation for the first 8 weeks then standard of care for the following 8 weeks
干预措施: standard of care (Other)
Control
Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks
干预措施: Visual Stimulation (Device)
结局指标
主要结局
Visual field perimetry measured using the Esterman binocular field test
时间窗: From enrollment to the end of follow up period at 6 months
Increase at least 3 points in the number of points perceived in the blind field at the Esterman binocular field test after intervention (8 weeks) when compared to baseline and between control and interventional group.
次要结局
- Participant-reported a vision impairment specific quality of life questionnaire: Impact of Vision Impairment Questionnaire (IVI).(From enrollment to the end of follow up period at 6 months)
- Reading speed - Minnesota Low Vision Reading (MNREAD) test(From enrollment to the end of follow up period at 6 months)