Rehabilitation of Visual Function After Brain Injury - Effect of Neuro Vision Technology (NVT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Ability to complete a mobility route
研究概览
简要总结
In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people after stroke. Vision is the most important sense in humans, and even smaller permanent injuries can drastically reduce quality of life.
Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating effects. Reduced vision results in impaired balance, increased risk of serious falls, increased support needs, reduced quality of life, and impaired ability to perform activities of daily living. Restoration of visual field impairments occur only to a small extent during the first month after brain damage, and therefore the time window for spontaneous improvements is very limited. Hence, brain-impaired persons with visual impairment will most likely experience chronically impaired vision already 4 weeks after brain injury and the need for visual compensatory rehabilitation is substantial.
Neuro Vision Technology (NVT) is an supervised training course where people with visual impairments are trained in compensatory techniques using special equipment. Through the NVT process, the individual's vision problems are carefully investigated and personal data is used to organize individual training sessions that practice the individual in coping with situations that cause problems in everyday life.
The purpose of this study is to investigate whether rehabilitation with NVT can cause significant and lasting improvement in functional capacity in persons with chronic visual impairments after brain injury. Improving eyesight is expected to increase both physical and mental functioning, thus improving the quality of life. Participants included in the project will be investigated in terms of both visual and mental functions, including quality of life, cognition and depression. Such an investigation has not been performed previously and can have a significant impact on vision rehabilitation both nationally and internationally.
详细描述
Background and purpose
Stroke is the main cause of brain injury in Denmark, is the most common cause of invalidity among adults and affects 11,000 Danes annually. By comparison, the second most common cause of brain damage is traumatic brain injury, affecting 3,000 Danes annually. In total, approx. 22,000 children and adults annually experience brain injury in Denmark.
In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people with stroke. In general, vision is the most important sense in humans, thus even small permanent deficits can dramatically affect the quality of life.
Lack of vision (anopia) after brain damage limits rehabilitation and enhances other invalidating effects. Impaired vision results in impaired balance, increased risk of serious falls, increased support needs, reduced quality of life and impaired ability to perform activities of daily living. Recovery of visual field deficits occurs primarily and only to a modest extent the first month after brain injury, and thus the time window for spontaneous improvements is very limited. Hence, brain-impaired persons with visual impairment will most likely experience chronically impaired vision already 4 weeks after brain injury, and the need for visual compensatory rehabilitation is substantial.
Neuro Vision Technology (NVT) is a supervised training course where people with visual field deficits are trained in compensatory and restorative techniques. The course includes a special computer program, a light panel and a special training program, and the course is conducted with Certified Orientation & Mobility Instructors (O & M instructors) with visual expertise. Through the NVT course, the individual's specific vision deficits are carefully identified through a five-step program. Personal data is used to organize individual training and thereby teaching the individual to cope with situations that cause problems in everyday life. In spite of reported positive results of NVT training among several individuals, there are currently few and insufficient scientific studies on whether rehabilitation with NVT results in lasting and clinically significant improvements in people with severe and chronic visual field impairments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 years or older with brain injury.
- •Persons who experience significant vision impairment.
- •Eye sight 6/18 or better.
- •The time from symptoms onset to study inclusion is between 6 weeks and 9 months.
排除标准
- •Cognitive dysfunction.
- •Persons with anosognosia or severe neglect.
- •Inability to move independently at least 35 meters with or without assistance, including wheelchairs.
- •Inability to understand Danish or with communication disorders that prevent participation in tests.
- •Terminal disorder, other progressive disorder.
- •Significant abuse of alcohol or euphoric or narcotic drugs.
- •Serious disorders such as mental illness, especially severe depression.
- •New brain injury or other significant disorders emerging after study inclusion.
- •Impaired vision not due to brain damage, where the disorder is not considered to be permanent or where the field of vision does not cause significant disability.
结局指标
主要结局
Ability to complete a mobility route
时间窗: 3 months
Target identification and thus to compare how many targets are seen after the intervention.
次要结局
- Test of Attentional Performance (TAP) Test 2.3: Visual Field(3 months)
- Short Form (36) Health Survey (SF-36)(3 months)
- Fatigue Severity Scale-7(3 months)
- Montreal Cognitive Assessment (MoCA)(3 months)
- Multidimensional Fatigue Inventory 20 (MFI-20)(3 months)
- Time to complete a mobility route(3 months)
- Rey-Osterrieth's complex figure test(3 months)
- Modified Barthel-100 Index(3 months)
- National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)(3 months)
- Hemisphere differences(3 months)
- Behavioral Inattention Test (BIT)(3 months)
研究者
Rune Skovgaard Rasmussen
MSc, Ph.D., associate professor
Copenhagen University Hospital at Herlev