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临床试验/CTRI/2018/06/014448
CTRI/2018/06/014448尚未招募不适用

Correlation between visual impairments and functional balance in children with cerebral palsy.

DJST1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年10月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1)To find correlation between Pediatric Balance Scale(PBS) with Visual Classification Scale (VCS).

研究概览

简要总结

Background: A typicallydeveloping child has an overall feedback from somatosensory, visual, auditoryand vestibular systems which affects development of physical and emotionalgrowth. Although the normal visual system is not mature at birth and needs muchof the first 6months to become useful, enough visual stimuli reach thedeveloping brain to make vision a motivator for bonding and head control.  A child with cerebral palsy may haveimpairments in any of these systems thus leading to delayed achievement ofmilestones, being more or less dependent for activities of daily living onparents and thereby lesser opportunities for overall development. Aphysiotherapist treats a child with cerebral palsy with a broad goal ofimproving independence and increasing quality of life both for them and theirparents.

Impairedvision can interfere in the growth emotionally as well as physically. The firstmotor milestone of head control may be delayed or unachieved. A child will betempted to raise, move head and body in direction of visual and auditorystimuli. Various factors like level of spasticity, tightness, voluntarycontrol, cognition can affect motor development along with vision. The motorrecruitment, firing, strength of muscle contraction will impair balance andposture development. The correlation between visual deficitsand functional balance can help early identification and correction to helpachievement of milestones .Hence the need for the study is to correlatevisual impairment and  balance scales PBS& ECAB and GMFCS.

Aim: To find thecorrelation between visual impairments and functional balance in children withcerebral palsy.

Objectives: To find correlation of  PBS, ECAB and GMFCS

1)   With VCS

2)   With VisualAcuity

3)   With  Refraction

4)   WithBinocular Vision and Ocular Motility

 Methodology :

An observationalstudy will done in children with cerebral palsy of 1.5  – 10 years of age, who will be screened for inclusion andexclusion criteria selected through convenient sampling between November2018 – August 2019 in the physiotherapy department of a tertiary hospital. Adetailed explanation of the purpose and the procedure of the study will begiven to the parents of eligiblechildren and will be requested to participate in the study by signing theInform Consent Document. Also, whereverapplicable, for children above 7 years of age - the child’s assent will betaken separately after the study procedure has been explained.  Physiotherapeutic assessmentswill be performed including scales for balance assessments like PBS & ECABand GMFCS  on all the children in thephysiotherapy department of a tertiary hospital. These children will undergoroutine ophthalmologic examination carried out by the ophthalmology departmentwithin the same tertiary hospital which includes tests for visual functions anda visual classification scale(VCS). The VCS levels will be correlated with PBS& ECAB and GMFCS . Also, visual acuity, refractive errors, the various componentsof binocular vision and ocular motility will each be correlated with PBS &ECAB and GMFCS .

The statistical analysis will be performed using IBM SPSSStatistics 23. Quantitative variables like age, height, weight, range ofmotion, etc. will be expressed as mean, median and standard deviation. Allquantitative data would be tested for normality using the Kolmogorov Smoimovtest or the Shapiro Wilk test. Qualitative data like gender, presence forvisual acuity, binocular single vision, ocular motility, refraction and levelsof Visual Classification Scale will be expressed as frequency and percentages.

The correlation of PBS, ECAB and GMFCS with VCS will be doneby Chi Square test. The relationship between PBS and ECAB with Visual Acuitywill be done using Pearson correlation test or Spearman’scorrelation test. The correlation of PBS withRefraction and Binocular single vision ,ocular motility will be analyzed usingMann-Whitney U test or Kruskal Wallis H test. The correlation of ECAB withRefraction and Binocular single vision ,ocular motility will be done by usingMann-Whitney U test. The relationship between GMFCS and Visual Acuity,Refraction and Binocular single vision ,ocular motility will be analyzed usingChi Square test. p value less than 0.05 will be considered significant.

研究设计

研究类型
Observational

入排标准

年龄范围
1.50 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children with ante-natal, peri-natal and post-natal events of neurological damage.

排除标准

  • Uncontrolled epilepsy.
  • b) Auditory loss or impairment.
  • c) Severe tightness and deformity.

结局指标

主要结局

1)To find correlation between Pediatric Balance Scale(PBS) with Visual Classification Scale (VCS).

时间窗: 1 week

次要结局

  • 1)To find correlation between Pediatric Balance Scale(PBS) with Visual acuity, refraction, binocular vision and ocular motility(3 months)

研究者

发起方
DJST
申办方类型
Research institution and hospital

研究点 (1)

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