| CTRI Number |
CTRI/2024/12/078009 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Co-relation between Play activities and Motor Development in Preschool Children -An Observational Study. |
|
Scientific Title of Study
|
Co-relation between Play activities in Motor Development of Preschool Children -An Observational 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 |
Rochelle Fernandes |
| Designation |
Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
EWS 39 Ashok Nagar Belagavi
Belgaum
KARNATAKA
590016
India |
| Phone |
8296048592 |
| Fax |
|
| Email |
milagrinfernandes24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Paediatrics , JNMC Campus , Nehru Nagar Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Paediatrics , JNMC Campus , Nehru Nagar Belagavi
KARNATAKA
590001
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research Center, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vinuta Deshpande |
KAHER Institute of Physiotherapy |
Advanced Physiotherapy Center , Room NO.39, Sagar Floor , KLE Dr Prabhakar Kore Hospital ,Belagavi
Belgaum
KARNATAKA |
8754466612
vinutagangavatikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Motor Development of Preschool Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
participants whose parents are willing to give consent. the study includes participants who are between 3-5 years of age. children who are healthy and free from physical or developmental disability. |
|
| ExclusionCriteria |
| Details |
Children above 5 years of age will be excluded.Children with significant cognitive impairment or behavioural disorders will be excluded. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PDMS -2 |
Not applicable
T0 at the time of assesment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
10/01/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
Introduction- Motor development can be described as the ongoing
evolution of motor skills throughout a person’s life, influenced by the
individual’s biological makeup, the demands of specific motor tasks, and the
surrounding environmental factors. objectives- To determine the correlation between play activities and motor development
in preschool children using Peabody developmental motor scale-2 [PDMS -2] Inclusion criteria- Participants
whose parents are willing to give consent. The
study includes participants who are between 3 to 5 years of age. Children
who are healthy and free from physical or developmental disability. Exclusion criteria- Children above 5 years of age will be
excluded.
Children with
significant cognitive impairment or behavioural disorders will be excluded.Procedure- An
ethical clearance will be obtained from the institutional ethical committee. The
list of preschools in Belagavi city will be collected from block division
office, Belagavi. Preschools
will be randomly selected through the random number table. Permission
will be obtained form the School authorities. The
purpose of the study will be explained and written informed consent will be
obtained from all parents and teachers of the participants. Participants
will be screened based on inclusion and exclusion criteria. Questionnaire will be distributed to the teachers in
the preschool. Brief demographic data will be obtained from the
parents of the participants prior to the assessment. A room will be designated in the school for conducting
the PDMS assessment. With the use of pea body developmental motor scale,
the participants will be assessed on the motor development. The data will be then collected , tabulated , and
analyzed.
|