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CTRI Number  CTRI/2018/05/013622 [Registered on: 02/05/2018] Trial Registered Prospectively
Last Modified On: 24/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of Visual Stimulation on the Eye Function of Children with Cerebral Palsy. 
Scientific Title of Study   Effect of Visual Stimulation on Visual Function in Children with Cerebral Palsy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti S Jeevannavar 
Designation  Associate Professor 
Affiliation  S.D.M. College of Physiotherapy 
Address  S.D.M. College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9972189767  
Fax  08362462253  
Email  drjyotisj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti S Jeevannavar 
Designation  Associate Professor 
Affiliation  S.D.M. College of Physiotherapy 
Address  S.D.M. College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9972189767  
Fax  08362462253  
Email  drjyotisj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti S Jeevannavar 
Designation  Associate Professor 
Affiliation  S.D.M. College of Physiotherapy 
Address  S.D.M. College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9972189767  
Fax  08362462253  
Email  drjyotisj@gmail.com  
 
Source of Monetary or Material Support  
S.D.M. College of medical Sciences and Hospital Dharwad 
 
Primary Sponsor  
Name  Dr Jyoti S Jeevannavar 
Address  S.D.M. College of Physiotherapy Manjushree Nagar Sattur Dharwad 
Type of Sponsor  Private medical college 
 
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 
Dr Jyoti S Jeevannavar  SDM College of Medical Sciences and Hospital  OPD Number 13, Paediatric Physiotherapy OPD, SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur
Dharwad
KARNATAKA 
9972189767
08362462253
drjyotisj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S.D.M. Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cerebral palsy, (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  not applicable 
Intervention  Visual Stimulation  Visual Stimulation will be given  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children with cerebral palsy with absent visual fixation and tracking and developmental delay in their gross and fine motor skills.
 
 
ExclusionCriteria 
Details  Children with damage to the anterior portion of the eyes.
Children with uncontrolled seizures
Children of parents who do not consent for their child’s participation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Evoked Potentials  Before commencing protocol, and after 1 month and then 3 months of protocol 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   Phase 1 
Date of First Enrollment (India)   07/05/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Vision is our dominant sense. Lingering vision conditions impede rehabilitation therapies. Children with visual impairments are at a greater risk for developing delays. Motor development relies greatly on vision to encourage children to move. Curiosity and motivation to explore the visual stimulus in a child, assists with the development of head control, crawling, walking and learning to manipulate objects. It is thus important to identify interventions which could possibly decrease the burden of blindness while improving visual abilities and giving more chances and opportunities for global development of the children. It is also important to come up with more cost effective and simple to use interventions for the same. A dearth of studies focusing on these issues, gives rise to the need for study in the said field.

 
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