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CTRI Number  CTRI/2022/01/039604 [Registered on: 20/01/2022] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Early exposure to toy on motor development in high risk babies  
Scientific Title of Study   Impact of early exposure to play materials on motor development in high risk infants- A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrunmayi Sandip Gadre 
Designation  PG student  
Affiliation  KAHER Institute of Physiotherapy 
Address  Department of Pediatric Physiotherapy KAHER Institute of Physiotherapy JNMC CAMPUS

Belgaum
KARNATAKA
590010
India 
Phone  09822164497  
Fax    
Email  gadremrunmayi477@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinuta Deshpande 
Designation  Assistant Professor  
Affiliation  KAHER Institute of Physiotherapy 
Address  Department of Pediatric Physiotherapy KAHER Institute of Physiotherapy JNMC CAMPUS

Belgaum
KARNATAKA
590010
India 
Phone  8754466612  
Fax    
Email  vinuta.gangavatikar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinuta Deshpande 
Designation  Assistant Professor  
Affiliation  KAHER Institute of Physiotherapy 
Address  Department of Pediatric Physiotherapy KAHER Institute of Physiotherapy JNMC CAMPUS

Belgaum
KARNATAKA
590010
India 
Phone  8754466612  
Fax    
Email  vinuta.gangavatikar@gmail.com  
 
Source of Monetary or Material Support  
KAHER Institute of Physiotherapy,JNMC Nehru Nagar, Belagavi 
 
Primary Sponsor  
Name  Mrunmayi Sandip Gadre 
Address  Department of Pediatrics Physiotherapy KAHER Institute of Physiotherapy 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrunmayi Gadre  KLES Dr. Prabhakar Kore hospital  Pediatric Physiotherapy OPD, Physiotherapy dept. J.N medical college campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 
9822164497

gadremrunmayi477@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pre-term infants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Early awareness about play materials   Will be given standard education about importance of early exposure towards play material, where the parents will be first asked about the toys they usually use to play with their infants’, they will be also asked about the time they give their babies to play or how many times a day the baby likes to grab a toy and play with it. First pre assessment will be done and after giving 6 weeks of intervention post assessment will be taken. 
Intervention  Early exposure to play materials  The below listed toys will be provided to the infants, the intervention will be given once in the form of toy kit Age appropriate toy kit (6months age) 1. Rattles 2. Squeeze Toys 3. Teething Toys 4. Functional Toys as toys with music and lights. 5.Nesting cups The intervention will be given for 6 weeks and then the post assessment will be done  
 
Inclusion Criteria  
Age From  5.00 Month(s)
Age To  6.00 Month(s)
Gender  Both 
Details  Infants in the corrected age of 5 months 0 day to 6 months 30 days.
The parent-infant dyad is a permanent resident of Belagavi city.
Both the genders
Parents willing to participate in the study
 
 
ExclusionCriteria 
Details  History of or diagnosed with any birth defect or congenital abnormality.
Recent surgeries in 3 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Peabody Developmental Motor Scales -Second Edition (PDMS-2)  Baseline and after 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   30/01/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized controlled trial to study the impact of early exposure to play materials on motor development in high risk infants. Baseline assessment will be taken by using PDMS-2 as an outcome measure. All the participants will be screened and recruited according to the inclusion and exclusion criteria. The sample size is total 36 which will be divided into 2 groups, 18 in control group and 18 in experimental group. The intervention given to both the groups will be for 8 weeks. Post assessment will be done after 8 weeks using PDMS-2. 
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