| CTRI Number |
CTRI/2025/08/093284 [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
|
How Playing Together Helps Babies Learn and Parents Connect in Low-Income Families |
|
Scientific Title of Study
|
Effect of Play-Based Intervention on Parent-Child Interaction, Infants Development and Exploratory Behaviour: A Randomized Controlled Trial in Low SES Families |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Sankapal |
| Designation |
Postgraduate |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
Advance Physiotherapy Center, Department of Pediatrics, Physiotherapy room no 39, Sagar floor, KLE DR Prabhakar Kore Hospital & MRC, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6366038601 |
| Fax |
|
| Email |
abhisheksankapal2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
associate proffessor |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
Advance Physiotherapy Center, Department of Pediatrics, Physiotherapy room no 39, Sagar floor, KLE DR Prabhakar Kore Hospital & MRC, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek sankapal |
| Designation |
postgraduate student |
| Affiliation |
KLE Institute of physiotherapy Belagavi |
| Address |
Advance Physiotherapy Center, Department of Pediatrics, Physiotherapy room no 39, Sagar floor, KLE DR Prabhakar Kore Hospital & MRC, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
06366038601 |
| Fax |
|
| Email |
abhisheksankapal2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research Center, Nehuru Nagar, Belagavi 59001, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Abhishek Sankapal |
| Address |
Advance Physiotherapy Center, Department of Pediatrics, Physiotherapy room no 39, Sagar floor, KLE DR Prabhakar Kore Hospital & MRC, Belagavi- 590010 |
| Type of Sponsor |
Other [selfnsponserd] |
|
|
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 |
| Abhishek sankapal |
slums of belagavi city |
Belagavi city, Belagavi, Karnataka, India 590010
Belgaum
KARNATAKA |
06366038601
abhisheksankapal2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
play based intervention |
The low socioeconomic status family will be identified, we will visit their house, a pre-assessment will be done, and a 6-month age-appropriate play kit will be given. And they will be taught to parents how to perform the task. And at 9 months, again revisit their home, assessment will be done, and a 9-month age-appropriate toy kit will be given, and they will be taught how to perform the task. and at the 12-month assessment will be done |
| Comparator Agent |
play based intervention |
The low socioeconomic status family will be identified, we will visit their house, a pre-assessment will be done, and a 6-month age-appropriate play kit will be given. We will not give exact information about the task to will inform family members to play with those toys. At 9 months, again revisit their home, assessment will be done, and a 9-month age-appropriate toy kit will be given. And we will not give exact information about the task, to will inform family members to play with those toys. and at the 12-month assessment will be done |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
•5 months 0 days to 6 months 30 days old Male and female Infants residing in slum areas of Belagavi
•Low SES as per the Kuppuswamy scale
•Parents who are willing to participate in the study
•Infants with gestational age of more than 37 weeks and birth weight of more than 2.5 kg
|
|
| ExclusionCriteria |
| Details |
•Children diagnosed with hearing or visual impairment
•No neurological trauma in the infant.
•Diagnosed with neurological disorders like epilepsy, autism, brain tumors, cerebral palsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregiver Reported Early Development Instrument |
t0: at baseline at 6 months
t1: at 9 months of age
t2: post assessment at 12 month of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| infant & toddler curiosity questionnaire |
t0: at baseline at 6 months of age
t1: at 9 months of age
t2: at post assessment at 12 month of age |
| toy & play time questionnaire |
t0: at baseline at 6 months of age
t1: at 9 months of age
t2: at post assessment at 12 month of age |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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="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
|
This study aimed to assess how play-based activities affect bonding between parents and infants, promote developmental milestones, and improve curiosity-driven exploration in low-income families. Thirty infants aged 5–6 months were randomly assigned to intervention or control groups. The intervention group received guided play sessions and kits, showing potential benefits for cognitive, motor, and social development. |