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CTRI Number  CTRI/2025/10/096345 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Making a questionnaire to find out how much parents are aware about the role of toys in the development of children 
Scientific Title of Study   Development And Content Validation Of A Questionnaire To Assess The Knowledge Of Parents Of Children Aged 0-2 Years About The Use Of Toys For Child Development 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Shubha R Nayak 
Designation  Assistant Lecturer 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Shubha R Nayak 
Designation  Assistant Lecturer 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mrs Shubha R Nayak 
Designation  Assistant Lecturer 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Kasturba Hospital, Manipal, Udupi - 576104 Karnataka, India 
 
Primary Sponsor  
Name  Mrs. Shubha R Nayak 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104 
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 
Dr Bhamini K Rao  Kasturba Hospital   Department of Physiotherapy, N1 103 Udupi, Karnataka
Udupi
KARNATAKA 
8660644145

bhamini.kr@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  N/A 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Experts who have minimum 2 years of experience in their respective field
1. Paediatric Physiotherapy
2. Paediatric Occupational Therapy
3. Psychologist
4. Paediatrician
5. Language expert
6. Speech and language pathologist
 
 
ExclusionCriteria 
Details  not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
development and content validation of a questionnaire to assess the knowledge of parents of children aged 0-2 years regarding the use of toys for child development   development and content validation of a questionnaire to assess the knowledge of parents of children aged 0-2 years regarding the use of toys for child development  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size
Modification(s)  
Total Sample Size="20"
Sample Size from India="20" 
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)   02/11/2025 
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="1"
Months="0"
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  

Various theories of motor control have been proposed, that explain how children develop and improve motor skills. It is theorised that as a child develops, there is a shift from reflexes to coordinated and planned movement. Movements are stored in the brain and are refined by consistent practice. It is believed that the development of movement is affected by the task, the individual and the environment. 

            Children learn to move by adapting to the environment. Parents play an important role in aiding a child’s development by constructing and enhancing the environment and thereby the development of their child(ren). This can be achieved by adding toys to the mix.

            The use of toys as an adjunct to therapy has been extensively studied, and the benefits have been noted in various domains. Improvement in a child’s cognitive, social, motor, psychological, and sensory development following the addition of play with toys to the treatment plan has been documented.  

            Toys are useful in promoting overall growth in children with and without developmental disabilities. They are especially helpful in a therapeutic setting as they increase a child’s motivation, engagement, focus, and participation, thus making the rehabilitation process more efficient.  

            Despite the existence of substantial evidence regarding the benefits of toys, many parents are not fully aware of how toys can support the development of their child. Parents are of the belief that toys play little to no part in their child’s overall development.  

            It is important to discern the areas in which knowledge of parents can be increased. It will be useful for therapists to recognise how they can better parental education regarding the benefits of toys and address and overcome the barriers to the use of toys as an adjunct to therapy. 

            The aim of our study is to develop and content validate a questionnaire that assesses the knowledge of parents regarding the use of toys for child development. 


 
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