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
|
|
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
|
|
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. |