| CTRI Number |
CTRI/2025/08/093283 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
"Play Helps Motor Skills in Young Kids from Low-Income Families—A Randomized Study" |
|
Scientific Title of Study
|
Impact of play based intervention on motor development in early toddlers in low socioeconomic background- A randomized controlled Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Gunjal |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy, room no 39,sagar floor, KLE DR.Prabhakar Kore Hospital and MRC , Belgaum , Karnataka , 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9632640538 |
| Fax |
|
| Email |
gunjalpragati12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy, room no 39,sagar floor, KLE DR.Prabhakar Kore Hospital and MRC , Belgaum , Karnataka , 590010 India
Belgaum
KARNATAKA
500010
India |
| Phone |
08754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Gunjal |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy, room no 39,sagar floor, KLE DR.Prabhakar Kore Hospital and MRC , Belgaum , Karnataka , 590010 India
Belgaum
KARNATAKA
5900010
India |
| Phone |
9632640538 |
| Fax |
|
| Email |
gunjalpragati12@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research centre, Nehru nagar, Belagavi , Karnataka, 590010 |
|
|
Primary Sponsor
|
| Name |
Pragati Gunjal |
| Address |
Advanced Physiotherapy centre, department of Pediatric physiotherapy room no 39,sagar floor, Belgaum, Karnataka, 590010 |
| Type of Sponsor |
Other [] |
|
|
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 Pragati Gunjal |
Anganwadi centre |
anganwadi centres in belgaum
Belgaum
KARNATAKA |
9632640539
gunjalpragati12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy toddlers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
play based intervention |
control group participants will be given a play kit and educational material and parents will follow the instructions and perform the activities for their child.
The control group participants will be given standard care intervention and intervention is given for 4 times a week for 6 months for 30 to 45 mins.
|
| Intervention |
Play based intervention |
The play kit will be provided to experimental group participants, and an educational material book will be given to parents and the activities will be demonstrated to the parents by the investigator.
The intervention will be given only for the experimental group for 4 times per week for 6 months for 30-45mins at the toddlers home.
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Month(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
Children born between Jan 2023 to Jan 2025
Children with low SES and residing in Belagavi City
Both Gender
Children with gestational age more than 37 weeks and birth weight more than 2.5kg
Children of the parents who are willing to participate |
|
| ExclusionCriteria |
| Details |
Children who are having any physical or developmental disability
No neurological trauma to the child
Children diagnosed with any hearing or visual impairments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global scale for early development long form |
T-0 baseline assessment (Before intervention)
T1- first follow-up at 12 weeks
T2- After intervention assessment at the end of 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Toy & playtime questionnaire |
T-0 baseline assessment (Before intervention)
T1- first follow-up at 12 weeks
T2- After intervention assessment at the end of 24 weeks |
| PDMS |
T-0 baseline assessment (Before intervention)
T1- first follow-up at 12 weeks
T2- After intervention assessment at the end of 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
09/09/2025 |
| 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="30" |
|
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
|
This randomized controlled trial evaluates the impact of a structured, age-appropriate play-based intervention on motor development in 28 low-SES toddlers (11–18 months) in Belagavi. The experimental group receives play kits with parental training; the control group gets activity booklets. Outcomes include motor skills, toy availability, and parent–child interaction, aiming to bridge developmental gaps and promote equal opportunities. |