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CTRI Number  CTRI/2018/06/014448 [Registered on: 07/06/2018] Trial Registered Prospectively
Last Modified On: 06/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Do vision and balance in children with cerebral palsy relate with each other? 
Scientific Title of Study   Correlation between visual impairments and functional balance in children with cerebral palsy. 
Trial Acronym  VCS,ECAB,PBS,CP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Archana Gore 
Designation  Assistant Professor 
Affiliation  Physiotherapy School and Center, seth GSMC & KEM hospital 
Address  402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9223256919  
Fax    
Email  nilarch17@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Archana Gore 
Designation  Assistant Professor 
Affiliation  Physiotherapy School and Center, seth GSMC & KEM hospital 
Address  402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12
402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9223256919  
Fax    
Email  nilarch17@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Ms Charmi Parmar 
Designation  MPTh student 
Affiliation  Physiotherapy School and Center, seth GSMC & KEM hospital 
Address  402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12
402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9223256919  
Fax    
Email  parmarcharmi@yahoo.com  
 
Source of Monetary or Material Support  
Seth GSMC & KEM hospital 
 
Primary Sponsor  
Name  DJST 
Address  Seth GSM college & KEM hospital 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Archana Gore  PT department,KEMH  Pediatric neurorehabilitation section, Room number 5,ground floor, 402
Mumbai (Suburban)
MAHARASHTRA 
9223256919

nilarch17@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children with crebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.50 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children with ante-natal, peri-natal and post-natal events of neurological damage. 
 
ExclusionCriteria 
Details  Uncontrolled epilepsy.
b) Auditory loss or impairment.
c) Severe tightness and deformity.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To find correlation between Pediatric Balance Scale(PBS) with Visual Classification Scale (VCS).  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1) To find correlation between Pediatric Balance Scale(PBS) with Visual acuity, refraction, binocular vision and ocular motility   3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: A typically developing child has an overall feedback from somatosensory, visual, auditory and vestibular systems which affects development of physical and emotional growth. Although the normal visual system is not mature at birth and needs much of the first 6months to become useful, enough visual stimuli reach the developing brain to make vision a motivator for bonding and head control.  A child with cerebral palsy may have impairments in any of these systems thus leading to delayed achievement of milestones, being more or less dependent for activities of daily living on parents and thereby lesser opportunities for overall development. A physiotherapist treats a child with cerebral palsy with a broad goal of improving independence and increasing quality of life both for them and their parents.

Impaired vision can interfere in the growth emotionally as well as physically. The first motor milestone of head control may be delayed or unachieved. A child will be tempted to raise, move head and body in direction of visual and auditory stimuli. Various factors like level of spasticity, tightness, voluntary control, cognition can affect motor development along with vision. The motor recruitment, firing, strength of muscle contraction will impair balance and posture development. The correlation between visual deficits and functional balance can help early identification and correction to help achievement of milestones .Hence the need for the study is to correlate visual impairment and  balance scales PBS & ECAB and GMFCS.

 

Aim: To find the correlation between visual impairments and functional balance in children with cerebral palsy.

Objectives: To find correlation of  PBS, ECAB and GMFCS

1)    With VCS

2)    With Visual Acuity

3)    With  Refraction

4)    With Binocular Vision and Ocular Motility

 

Methodology :

An observational study will done in children with cerebral palsy  of 1.5  – 10 years of age, who will be screened for inclusion and exclusion criteria selected through convenient sampling between November 2018 – August 2019 in the physiotherapy department of a tertiary hospital. A detailed explanation of the purpose and the procedure of the study will be given to the parents of eligible children and will be requested to participate in the study by signing the Inform Consent Document. Also, wherever applicable, for children above 7 years of age - the child’s assent will be taken separately after the study procedure has been explained.  Physiotherapeutic assessments will be performed including scales for balance assessments like PBS & ECAB and GMFCS  on all the children in the physiotherapy department of a tertiary hospital. These children will undergo routine ophthalmologic examination carried out by the ophthalmology department within the same tertiary hospital which includes tests for visual functions and a visual classification scale(VCS). The VCS levels will be correlated with PBS & ECAB and GMFCS . Also, visual acuity, refractive errors, the various components of binocular vision and ocular motility will each be correlated with PBS & ECAB and GMFCS .

The statistical analysis will be performed using IBM SPSS Statistics 23. Quantitative variables like age, height, weight, range of motion, etc. will be expressed as mean, median and standard deviation. All quantitative data would be tested for normality using the Kolmogorov Smoimov test or the Shapiro Wilk test. Qualitative data like gender, presence for visual acuity, binocular single vision, ocular motility, refraction and levels of Visual Classification Scale will be expressed as frequency and percentages.

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

 
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