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临床试验/CTRI/2025/02/080831
CTRI/2025/02/080831招募中1/2 期

Integrating CVI with Developmental Therapy to Facilitate Early Development in at Risk Children for Motor Disability

Nilavan Thirumavalavan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月25日最近更新:

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

发起方
Nilavan Thirumavalavan
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nilavan Thirumavalavan

Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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