| CTRI Number |
CTRI/2023/01/049108 [Registered on: 19/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to assess the risk factors of injury during leisure and sports time among school going adolescents |
|
Scientific Title of Study
|
Physical Activity Related Injury and Its risk factors among adolescents in selected schools, Dakshina Kannada district, Karnataka- Cross-Sectional survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sasikumar S |
| Designation |
Professor & Head |
| Affiliation |
Father Muller College of Nursing |
| Address |
Department of Medical Surgical Nursing
5th Floor Father Muller College of Nursing, Father Muller road,
Kankandy, Mangalore, Dakshina Kannada district, Karnataka
Kankandy
Mangalore
Dakshina Kannada dist
Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sasikumar S |
| Designation |
Professor & Head |
| Affiliation |
Father Muller College of Nursing |
| Address |
Department of Medical Surgical Nursing 5th Floor Father Muller College of Nursing Father Muller Road Kankanady Mangalore Dakshina Kannada District Karnataka
Kankandy
Mangalore
Dakshina Kannada dist
Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sasikumar S |
| Designation |
Professor & Head |
| Affiliation |
Father Muller College of Nursing |
| Address |
Department of Medical Surgical Nursing 5th Floor Father Muller College of Nursing Father Muller Road Kankanady Mangalore Dakshina Kannada District Karnataka
Kankandy
Mangalore
Dakshina Kannada dist
Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College of Nursing
Father Muller Road Kankanady
Mangalore 575002
Dakshina Kannada District Karnataka |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
NEWDELHI |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Sasikumar S |
Father Muller college of Nursing |
Dr.Sasikumar S
Professor & HOD
Department of medical surgical Nursing
Father Muller College of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
9620410946
sasikrisna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
adolescents in selected schools |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents both boys and girls in age group 10-19 years
Adolescents who studying in the school under CBSE or ICSE or State board
|
|
| ExclusionCriteria |
| Details |
Adolescents who unable to participate any physical activity (Physically challenged)
Inability to provide parental consent 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 |
| Risk factors of Physical activity related injury |
April 2023 to Dec 2023 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the finding of the study can be well incorporated in creation of awareness, preparation of innovative product development, mitigating barriers, developing new guidelines to prevent and manage the sports injuries |
At base line only |
|
|
Target Sample Size
|
Total Sample Size="4000"
Sample Size from India="4000"
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)
|
01/06/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Physical Activity Related Injury and Its risk factors among adolescents in selected schools, Dakshina Kannada district, Karnataka- Cross-Sectional survey Study Objectives: Primary objectives 1. To determine the prevalence of level of physical activity related injury in sports and leisure time among adolescents in selected schools 2. To identify the risk factors of physical activity related injury 3. To find the association between physical activity related injury and selected demographic variables. Secondary objectives 4. To develop the prevention strategies of physical activity related injury among high risk group of adolescents
|