| CTRI Number |
CTRI/2025/03/082104 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Enhancing Early Assessment: Validation of the Visual Perception Skills Questionnaire for Primary School Children |
|
Scientific Title of Study
|
A New Approach: Validating the Visual-Motor Perceptual Skills Questionnaire for Children Enrolling in Primary School |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raj Kumar |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 306, Department of Optometry, School of Allied Health Sciences, Galgotias University Plot No 2, Sector 17A, Opposite Buddha Interantional Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9015872988 |
| Fax |
|
| Email |
raj@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 306, Department of Optometry, School of Allied Health Sciences, Galgotias University Plot No 2, Sector 17A, Opposite Buddha Interantional Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9015872988 |
| Fax |
|
| Email |
raj@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Biswas |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
B316, Department of Optometry,School of Allied Health Sciences, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08420961195 |
| Fax |
|
| Email |
vishalbiswas45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No 113, C block, Galgotias University, Plot No 2, Sector 17 A, opposite Buddha International Circuit Gautam Buddh Nagar, Greater Noida, Uttar Pradesh, India-203201 |
| Type of Sponsor |
Research institution |
|
|
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 Vishal Biswas |
Galgotias University |
Room No 525, B Block, Department of Optometry, School of Allied Health Sciences, Galgotias University Plot No 2, Sector 17A, Opposite Buddha Interantional Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
08420961195
vishalbiswas45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary school going children
2. Children with no behavioral issues
3. Parental Fluency in the language in which the questionnaire is administered
|
|
| ExclusionCriteria |
| Details |
1. Ocular& Systemic Comorbidities
2. H/o eye surgery or experienced trauma affecting 3. visual or motor functions
4. H/o birth abnormalities
5. Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accessible Screening: Simple, cost-effective tool for widespread, community-based assessments.
Early Detection: Identifies visual perceptual issues for timely intervention.
Improved Learning: Enhances academic performance by addressing perceptual difficulties.
Self-Empowerment: Enables self-assessment, prompting individuals to seek professional help.
Prevention: Reduces risk of undiagnosed issues affecting daily life activities.
First Made in India Product
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="227"
Sample Size from India="227"
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)
|
24/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Early childhood development is heavily dependent on visual-motor perceptual abilities, which affect learning, handwriting, and general academic achievement. This study seeks to test a novel **Visual-Motor Perceptual Skills Questionnaire (VMPSQ)** intended to evaluate these skills in children going to to primary school. The questionnaire offers a systematic and dependable instrument to assist educators, therapists, parents, and caregivers in identifying children who may need early interventions. The study encompasses a methodical validation procedure and reliability analysis, incorporating **expert evaluations and statistical analyses** to ascertain the questionnaire’s precision, dependability, and cultural pertinence. The research assesses essential elements like **visual perception, motor coordination, and integrative capabilities**, juxtaposing findings with established standardized evaluations.
The project seeks to validate and ensure the reliability of VMPSQ, positioning it as an accessible and effective screening instrument. Prompt diagnosis of children with visual-motor perceptual challenges might provide timely treatments, enhancing school preparedness and educational results. The study’s findings will enhance educational and therapeutic procedures, providing improved assistance for young learners during their crucial developmental stages. This research advocates for a more inclusive and proactive methodology in early childhood education, guaranteeing that each kid has the requisite assistance for academic success.
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