| CTRI Number |
CTRI/2024/05/067000 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation Between Different Factors and Growth in Play group Children |
|
Scientific Title of Study
|
Association of Various Factors and Development in Preschoolers (2 to 5 years)-A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devyani Srinivasan Sastri |
| Designation |
Postgraduate Student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First Floor, Department of Neurophysiotherapy, Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12,Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9665865893 |
| Fax |
|
| Email |
devyanisastri2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor of Neuro Physiotherapy Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First Floor, Department of Neurophysiotherapy, Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12,Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor of Neuro Physiotherapy Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First Floor, Department of Neurophysiotherapy, Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12,Thube Park, Shivaji Nagar, Pune.
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy, Pune, Maharashtra, India
Pincode- 411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005
MAHARASHTRA |
| 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 Devyani Srinivasan Sastri |
Preschools |
Preschools around Pune Maharashtra
Pune
MAHARASHTRA |
9665865893
devyanisastri2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preschoolers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2 to 5 years |
|
| ExclusionCriteria |
| Details |
1.Parents who refuse to give consent
2.Children with any neurological condition
3.Children with any visual, auditory and speech impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ages and Stages Questionnaire 3rd edition |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Kuppuswamy Scale
Parent style and Dimension Questionnaire |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "159"
Final Enrollment numbers achieved (India)="159" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/05/2024 |
| Date of Study Completion (India) |
14/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Identifying factors affecting and understanding it will provide a valuable insight in development of child. It will help parents and therapist to make appropriate decisions regarding their child’s environment, activities and overall upbringing. Knowledge of risk factors will allow implementation of preventive measures, reducing the incidence of developmental challenges. So, an understanding of the factors influencing child development will contribute towards enhancing the overall quality of life for children, ensuring that they will have future well-being. Hence, this study will be conducted to understand association among various factors affecting development of preschooler.
|