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
|
|
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
|
|
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. |