| 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
|
|
|
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
|
|
|
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.
|