Rehabilitative effectiveness of visuo-stimulation, visuo-motor and visuo-perceptual learning interventions in improving neuro-visuo-cognitive behaviour in children with CVI compared to standard care: A randomised control pilot study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome is improvement in FUNCTIONAL VISION in terms of
研究概览
简要总结
This study aims to study rehabilitative effectiveness of vision therapy in improving visual attention, visuo-perceptual, visuo-motor and visuo-cogntive behaviour in children with cerebral visual impairment by conducting a randomised controversy study where patients will be divided into two arms: one arm shall receive standard therapy and other would receive vision therapy apart from standard management. Vision therapy will include home based tailored visual stimulation, visuo-motor, visuo-perceptual and cognitive tasks depending on child’s functional vision. Children with suspected CVI will be observed and proforma will be filled up with regard to their neuro-visual behaviours, characteristic findings, visual grade, oculomotility pattern, electrophysiological tests, fundus findings, imaging findings etc. All children will undergo detailed paediatric neurological evaluation. Imaging will be analysed by radiologists and scored. The rationale of the study is that home-based visual stimulation and rehabilitative strategies (tailored to the CVI inventory responses and examination findings) if explained to carers and carefully applied, can improve visual skills and neuro-visual behavior in children with cerebral visual impairment, thereby improving everyday visual functioning, participation, and quality of life as an ultimate goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.50 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria includes
- •patients with history and documentation of perinatal asphyxia, periventricular leukomalacia, hypoglycemia, perinatal infections, genetic, metabolic, hydrocephalus, or structural causes or
- •documented perinatal brain damage confirmed by a pediatric neurologist along with
- •MRI evidence of brain injury in a pattern typical of hypoxic-ischemic encephalopathy (HIE) including peri-ventricular leukomalacia (PVL)
- •problems in visual functioning (corroborated by results of functional vision assessment) or atypical neuro-visuo-behavior or visual perceptual or cognitive dysfunction on CVI inventory questionnaire and
- •confirmed on examination with at least 2 or more of the following: a) Deficit or impaired visual inattention, fixation, or inability to follow objects; b)Deficit visual guided reach or visual guidance of upper limbs (inability to reach out or hold a toy or difficulty in picking up a toy); c) Deficit visual communication/search/curiosity/ spatial orientation; d)Deficit visual processing like recognition of face/objects/facial expression or Difficulty with clutter.
排除标准
- •â€¢Children with pediatric cataracts, corneal pathologies, retinal pathologies, or dense amblyopia responsible for low vision •Retinopathy of prematurity of grade 4 or 5, and major ROP sequelae like falciform fold involving disc or macula nonresolving macular bleed, vitreous hemorrhage assessed by a paediatric ophthalmologist •Children with epileptic spasms, electroclinical epileptic encephalopathy, seizure frequency of more than one/month in the past 3 months or patients using anti-epileptic vigabatrin •Children with debilitating illnesses requiring immediate attention •Children whose caregivers refuse to participate in the study •Autistic children.
结局指标
主要结局
Primary outcome is improvement in FUNCTIONAL VISION in terms of
时间窗: outcome will be assessed at the end of 1 year
1. improvement in visual acuity,
时间窗: outcome will be assessed at the end of 1 year
2. visual attention (attention span, reaction time and number of orienting responses),
时间窗: outcome will be assessed at the end of 1 year
3. achieving steadiness of visual fixation,
时间窗: outcome will be assessed at the end of 1 year
4. improvement in visual communication,
时间窗: outcome will be assessed at the end of 1 year
5. improvement in visual guidance of limbs or visuomotor tasks
时间窗: outcome will be assessed at the end of 1 year
6. improvement in visual perception including cognition, recognition
时间窗: outcome will be assessed at the end of 1 year
次要结局
- •Imaging findings and correlation of imaging findings with clinical findings(•pre and post electrophysiologic findings (Improvement in P100 latency))