| CTRI Number |
CTRI/2025/02/081156 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occupational Therapists Role in Encouraging Physical Activity for Children and Teens in India |
|
Scientific Title of Study
|
Occupational Therapists Perception about Their Role in physical activity participation of children and adolescents in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivian Mdavire |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health
Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7349694636 |
| Fax |
|
| Email |
vimdav87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate professor and Head of the Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health
Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Rege |
| Designation |
Associate professor and Head of the Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy,Manipal Collge of Health
Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9739131050 |
| Fax |
|
| Email |
sumita.rege@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vivian Mdavire |
| Address |
Department of Occupational Therapy,Manipal Collge of Health
Professions,Manipal Academy of Higher Education, Manipal-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 Vivian Mdavire |
Manipal Collge of Health Professions |
Department of Occupational Therapy,Manipal Collge of Health
Professions,Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA |
7349694636
vimdav87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee- 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric Occupational therapist |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Occupational therapists who work with children and or adolescents in India |
|
| ExclusionCriteria |
| Details |
Occupation therapist who are not working with children and adolescents in India |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| understanding of the role that occupational therapy has in the enhancing physical activity participation among children Questionnare |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
05/03/2025 |
| 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="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim: To study Indian occupational therapists’ perception about their role in physical activity participation of children and adolescents
Justification for study: Physical activity for children and adolescents is known to be important in fostering health and well-being. However, research on the role of occupational therapists in promoting these activities in India is limited. This study aims to address this gap in knowledge by exploring the perceptions and practices of Indian occupational therapists in order to gather information about creating effective, culturally relevant interventions to encourage physical activity among children and adolescents.
Description of the procedure: The study will be conducted in two phases, Phase 1: Development and validation Once IRC approval is obtained, an online survey will be created. In addition, social media post samples will be prepared for approval from the IEC. Then the IEC approval will be obtained, followed by CTRI registration. After these approvals, the developed survey will be finalized following evaluation by three pediatric occupational therapists for its readability and content validation. Phase 2: Survey Once the survey is finalized, the student researcher will begin posting the approved posts, including a link to the online survey, on social media such as Facebook, Instagram, LinkedIn, WhatsApp, Manipal alumni groups, etc. targeting occupational therapy groups and forums where occupational therapists are active.
Data Analysis: All statistical analysis will be carried out at 5% level of significance using Jamovi 2.3.28 .
|