| CTRI Number |
CTRI/2025/07/090875 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Creating and Testing a Caregiver Manual to Help Improve Vision Skills in Children with Cerebral Palsy"
|
|
Scientific Title of Study
|
Development and validation of pegboard vision trainer caregiver manual for the children with cerebral palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kaviya B |
| Designation |
PG Student (1st year), Master of Optometry (M.OPTOM) |
| Affiliation |
Manipal college of Health Professions (MCHP) |
| Address |
Department of optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education and Research, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8610224597 |
| Fax |
|
| Email |
kaviya.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika |
| Designation |
Assistant Professor (senior Scale) Master of Optometry, (PhD) |
| Affiliation |
Manipal college of Health Professions (MCHP) |
| Address |
Department of optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education and Research, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8277412069 |
| Fax |
|
| Email |
radhika.pu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Judith Shefali Jathanna |
| Designation |
Assistant Professor, Master of Optometry (M.OPTOM) |
| Affiliation |
Manipal college of Health Professions (MCHP) |
| Address |
Department of optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education and Research, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008754240 |
| Fax |
|
| Email |
Judith.jathanna@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP), Manipal Institute of Higher Education and Education (MAHE), Manipal, Udupi, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Kaviya |
| Address |
Department of optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education and Research, Madhav Nagar, Manipal, Karnataka - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| kaviya B |
Kasturba Hospital |
Optometry Clinic, CTC, room no 315, Baliga block, Kasturba hospital, Manipal, Udupi district, Karnataka state, India - 576104.
Udupi
KARNATAKA |
8610224597
kaviya.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee - 2 (student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Optometrists with at least 5 years of experience working.
Parents/caregivers of children aged 2-17 years with Cerebral Palsy. |
|
| ExclusionCriteria |
| Details |
Caregivers unwilling to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Development of a validated Pegboard Vision Trainer Caregiver Manual.
2. Content Validity Index (CVI) scores to ensure expert consensus. |
Time Point - Activity/Event
Month 0 Ethics approval and preparation phase
Month 1–2 Development of the first draft of the manual based on literature and expert input
Month 3–4 Individual interviews with 5 optometrists for expert validation
Month 5–6 Feedback collection from 5 caregivers to assess usability
Month 7–8 Refinement and finalization of the manual based on expert and caregiver feedback
Month 9 Data analysis (qualitative coding + CVI scoring using Excel and ATLAS.ti)
Month 10 Final reporting and dissemination of validated manual
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Purpose of the Protocol:
To develop and validate a structured Pegboard Vision Trainer
Caregiver Manual aimed at improving the delivery and effectiveness of
home-based vision therapy for children with cerebral palsy.
Brief Statement of the Study
Hypothesis:
The hypothesis is that a validated caregiver manual for
pegboard vision training will be clear, practical, and usable, enabling
caregivers to effectively administer vision therapy at home for
children with cerebral palsy. |