Biofeedback Training to Improve Fixation Stability, Visual Function Outcomes, and Quality of Life in Hemianopia Cases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fixation stability
研究概览
简要总结
Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. Classic and effective saccadic compensatory training therapies are current aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind hemifield into the seeing hemifield for further processing. Patients learn, therefore, to efficiently use their eyes "to keep the 'blind side' in sight". Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.
详细描述
Background
Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. About 45% of stroke survivors have homonymous hemianopia. A deficit in vision and spatial perception can cause slowdown of the rehabilitation progress in physiotherapy.
According to Kerkhoff 1patients face three main visual behavioral problems: (1) impaired eye movements (including saccades) leading to defective visual and spatial exploration, (2) hemianopic reading deficit (hemianopic alexia) because of the parafoveal field loss and (3) deviated subjective midline. Hemianopic dyslexia is not simply the product of the visual field defect but is caused by a disorder of control of visual information processing and eye movements in reading.
Most important, the capability to read is fundamental for daily living and an essential prerequisite for education and success in our modern society, so this disorder can have a profound effect on patients' lives. Patients with visual field loss usually fail to adapt to their reading impairment (80% of cases). In these cases, word identification and the abilities to plan and guide reading eye movements are disturbed.
In spite of these facts, visual rehabilitation program on a larger scale is still missing in most rehabilitation centers and clinics. This is decurrent to the generalized belief that lesions of the lateral geniculate nucleus and striate cortex lead to a permanent loss of vision. According to scientific findings, this does not always have to be true.
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)
盲法说明
The assessor does not know if the patient is in the control group, treatment group or cross over group.
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemianopia cases previously diagnosed accordingly by microperimetry and other tests as needed
- •18-90 years old
- •ability to follow the visual and auditory stimuli and training instructions
排除标准
- •previous or current treatment for low vision rehabilitation
- •ocular diseases
- •other serious clinical conditions not related to the hemianopia physiopathology
- •both eyes with media opacity that impairs microperimetry testing
- •lack of ability to perform the tests and training
研究组 & 干预措施
Group A
The patients will undergo baseline assessment and receive the intervention, being assessed after the intervention.
干预措施: Biofeedback training (Device)
Group B
The patients will perform the same tests for assessment as in group A, however, no intervention will be done. They may enrol in the study as group B after completing group B participation.
结局指标
主要结局
Fixation stability
时间窗: 1 week post biofeedback
As measure by the MAIA microperimeter at the BCEA 63% ellipse area.
Reading speed
时间窗: 1 week post biofeedback
As measured with the MNRead charts
Visual Acuity
时间窗: 1 week post biofeedback
ETDRS best corrected visual acuity
Quality of Life Questionnaire scores
时间窗: 1 week post biofeedback
As measured with the Massof - 48 questionnaire
Retinal sensitivity
时间窗: 1 week post biofeedback
Paracentral (2 central vertical columns) and total average in dB as measured by the MAIA microperimeter.
Near vision
时间窗: 1 week post biofeedback
Measured with the Colenbrander 100% charts
次要结局
- Stereopsis(1 week post biofeedback)
- Contrast Sensitivity(1 week post biofeedback)
研究者
Monica Nido
Associate Professor
University Health Network, Toronto
