Integrating CVI with Developmental Therapy to Facilitate Early Development in at Risk Children for Motor Disability
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Age and Stage Questionnaire
研究概览
简要总结
This study, titled "Integrating Cortical Visual Impairment with Developmental Therapy to Facilitate Early Development in At-Risk Children for Motor Disability", aims to improve visual and motor functions in children aged 0–2 years with Cortical Visual Impairment (CVI). Using the innovative NILAS (Neuronal Integrative Linguistic Auditory Visual Stimulation) approach, the study integrates visual, auditory, and tactile stimuli to address CVI symptoms such as color preference, visual latency, and difficulties with visual novelty. Conducted as a pilot study at Saveetha Medical College and Hospital, the intervention involves 2 weeks of 1 hour 15 minutes sessions in a dark room, focusing on activities such as relaxation, tonal regulation, visuomotor training, and light-sound therapy. The primary outcome is developmental progress measured using the Ages and Stages Questionnaire (ASQ), while the secondary outcome evaluates motor skills using the Gross Motor Function Measure (GMFM-88). Statistical analysis employs SPSS, with descriptive and inferential methods used to assess outcomes. Parents of participants provide informed consent, and data privacy is ensured through de-identification. By combining sensory stimulation with developmental therapy, the study seeks to enhance early motor and visual development in children with CVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 2.00 Year(s)(—)
- 性别
- All
入选标准
- •children who were high risk newborn, with or with out damage to area other tan visual cortex.
排除标准
- •Children who are having congenital cataract, total damage to optic nerve, total retinal detachment or vitreous humor hemorrhage or any posterior capsule damage, hydrocephalus affecting the occipital lobe.
结局指标
主要结局
Age and Stage Questionnaire
时间窗: Baseline and 2nd Week
次要结局
- Modified Gross motor Functional measure(GMFM)(Baseline and 2nd Week)
研究者
Nilavan Thirumavalavan
Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences
