| CTRI Number |
CTRI/2025/06/088792 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Creating and testing a comprehensive physical,psychosocial and skill based fitness scale for school going children |
|
Scientific Title of Study
|
Development, Validation and Reliability Testing of Comprehensive Scale addressing Physical, Psychosocial and Skill Related Fitness in School going Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanu Goyal |
| Designation |
PhD Scholar |
| Affiliation |
Phd Scholar |
| Address |
Maharishi Markandeshwar deemed to be University ,Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Ambala
HARYANA
133207
India |
| Phone |
7015143108 |
| Fax |
|
| Email |
kanu.goyal@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Chatterjee |
| Designation |
Associate Profesor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be university,Mullana, Ambala, Haryana |
| Address |
room no: 4 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be university,Mullana, Ambala, Haryana
Mullana, Ambala, Haryama
Ambala
HARYANA
133207
India |
| Phone |
7015143108 |
| Fax |
|
| Email |
subhasishphysio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Kanu Goyal |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be university,Mullana, Ambala, Haryana |
| Address |
Room no.1, Maharishi Markandeshwar institute of physiotherapy and rehabilitatio,MM(DU),MULLANA,AMBALA,HARYANA
Ambala
HARYANA
133207
India |
| Phone |
7015143108 |
| Fax |
|
| Email |
kanu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar institute of physiotherapy and rehabilitatio,Maharishi Markandeshwar Deemed to be University Ambala Mullana,133207,India |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed to be University |
| Address |
Maharishi Markandeshwar institute of physiotherapy and rehabilitatio,Maharishi Markandeshwar Deemed to be University, Mullana-Ambala, Haryana,India,133207 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrKanu Goyal |
Maharishi Markandeshwar International school |
Room no: 101 ground floor Maharishi Markandeshwar International school Maharishi Markandeshwar deemed to be university
Ambala
HARYANA |
07082123862
goyalkanu02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ,MMIMSR, Ethical committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy School going children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children with aged between 10 and 16 years
Both boys and girls
Children able to understand simple commands
Children who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Systemic illness.
Musculoskeletal disorders
Neurological disorders
Psychological disorders
Fracture in upper or lower extremity in past 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive Scale addressing Physical, Psychosocial and Skill Related Fitness (CS-PPSF) |
BASELINE,2 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
30/06/2025 |
| 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="1"
Days="1" |
|
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
|
This trial needs to assess Psychosocial health of School going children in India |