| CTRI Number |
CTRI/2026/01/101846 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Joint Hypermobility Among School Aged Children |
|
Scientific Title of Study
|
Prevalence, demographic distribution and factors associated with joint hypermobility among school children: cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raziya Begum AS |
| Designation |
UG Student |
| Affiliation |
SRM college of Physiotherapy |
| Address |
Room no.PT29,4th floor,SRM college of Physiotherapy,SRM medical college hospital and research centre, SRMIST,Kattankulathur
,Chennai TAMIL NADU,603203
INDIA
Chennai
TAMIL NADU
603203
India |
| Phone |
9342662695 |
| Fax |
|
| Email |
raziyarazak2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate Professor |
| Affiliation |
SRM college of Physiotherapy |
| Address |
Room no.PT29,SRM College of Physiotherapy,SRM medical college building,SRM medical college hospital and research centre, SRMIST,Kattankulathur
,Chennai TAMIL NADU,603203
INDIA
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate Professor |
| Affiliation |
SRM college of Physiotherapy |
| Address |
Room no.PT29,SRM College of Physiotherapy,SRM medical college building,SRM medical college hospital and research centre, SRMIST,Kattankulathur
,Chennai TAMIL NADU,603203
INDIA
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raziya Begum AS |
| Address |
Room no.PT29,4th floor,SRM College of Physiotherapy, SRM medical college hospital and research centre, SRMIST,Kattankulathur,603203 |
| Type of Sponsor |
Other [(SELF SPONSOR)] |
|
|
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 |
| Raziya Begum AS |
SRM medical college hospital and research centre, SRMIST,Kattankulathur |
Room no.PT29,4th floor,SRM college of Physiotherapy,SRM medical college hospital and research centre, SRMIST,Kattankulathur
,Chennai TAMIL NADU,603203
INDIA
Room no.PT29,4th floor,SRM college of Physiotherapy,SRM medical college hospital and research centre, SRMIST,Kattankulathur
,Chennai TAMIL NADU,603203
INDIA
Chennai
TAMIL NADU |
09342662695
raziyarazak2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
JOINT HYPERMOBILITY AMONG SCHOOL CHILDRENS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
School children aged from 11 to 17 years.
Both boys and girls.
Children who provided parental written permission.
Students who provided written assent.
|
|
| ExclusionCriteria |
| Details |
School children with congenital deformities.
School children with congenital musculoskeletal disorders.
Recent (3 months ) musculoskeletal injuries .
Skin abrasion near the knee joint.
Exclude any painful condition that affects joint movements.
Children with poor cognition or unable to follow the instructions given by the data collector.
Children with visual, hearing, and speech impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of joint hypermobility among school children aged 11-17 years, assessed using the beighton score. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="376"
Sample Size from India="376"
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)
|
10/02/2026 |
| 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="3"
Days="4" |
|
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
|
The study was approved by institutional ethical committee Ethical clearance number SRMIEC-ST1225-5029 of SRM Medical College Hospital and Research Centre. The participants will be selected according to the inclusion criteria and will be informed about the study.The informed consent and informed assent form will be obtained from the participants. face to face interview will be conducted to the participants. A structured questionnaire will be used. The questionnaire contains demographic data, Beighton score, body measurements, musculoskeletal signs and symptoms, posture and limb conditions,activity and injury,physical activity level and the Nordic musculoskeletal questionnaire. a power calculated sample of n =338,with 10% contigency, resulting in final sample of n=376 was estimated. study setting is the government higher secondary schools boys and girls in Kallakurichi district, Chinna Salem,tamilnadu,606201. The collected data will undergo appropriate statistical analysis to draw meaningful conclusions. |