| CTRI Number |
CTRI/2025/07/092002 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence and Causes of Excessive Joint Movement in School Children |
|
Scientific Title of Study
|
Prevelence of Generalized Joint Hypermobility Syndrome and Predictors Associated Among School Children-A 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 |
Clement Marshal R |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no. PT 22, 4th floor SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar Potheri , Kanttankulathur, kancheepuram, TAMILNADU 603203, India
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9600272985 |
| Fax |
|
| Email |
clementmarshalr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Balamurugan Janakiraman |
| Designation |
Research Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no. PT 29, 4th floor SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar Potheri , Kanttankulathur, kancheepuram, TAMILNADU 603203, India
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Balamurugan Janakiraman |
| Designation |
Research Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no. PT 29, 4th floor SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar Potheri , Kanttankulathur, kancheepuram, TAMILNADU 603203, India
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar Potheri , Kanttankulathur, kancheepuram, TAMILNADU 603203, India |
|
|
Primary Sponsor
|
| Name |
Clement Marshal R |
| Address |
Room no. PT 22, 4th floor SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar Potheri , Kanttankulathur, Chengalpattu, TAMILNADU 603203, India |
| Type of Sponsor |
Other [Self funded ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balamurugan |
Don Bosco high school |
39, Officers Line, Sasthri Nagar, Krishna Nagar, Veerasamy Nagar, Vellore, Tamil Nadu 632001 Vellore TAMIL NADU |
9941215503
bala77physio@gmail.com |
| Dr Clement Marshal |
Municipal Primary School |
Room No:4 Ground Floor Kaspa Central MC Road Vellore Tamil Nadu India 632001 Vellore TAMIL NADU |
9600272985
clementmarshalr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
| SRM medical college hospital and research centre institutional ethics committee |
No Objection Certificate |
| SRM medical college hospital and research centre institutional ethics committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypermobility Syndrome M35.7 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
School students from grade 1 to grade 8( primary and middle school children)
|
|
| ExclusionCriteria |
| Details |
Any congenital neurological condition,
Children with congenital orthopedic condition,
Children with congenital cognition issues. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| beighton score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="377" Sample Size from India="377"
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)
|
20/08/2025 |
| 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="9" 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
|
The participants will be selected through inclusion and exclusion criteria. The research objectives will be explained to the participants. The participant will be included in the study with the written informed consent form. The aim of the study is to determine the prevalence of possible generalized joint hypermobility syndrome based on Beighton’s approach and factors associated with joint hypermobility among school children. During this study collects students name, age , gender, place as a demographic data . Personal characteristics will be measured and recorded, including height in centimeters, weight in kilos, sex, and age in years. The gold standard method (in bare feet; measured to the closest one centimeter and 100 grams, respectively) was used to measure weight and height. Using a metric method, weight (in kilograms) divided by height (in meters squared) was used to calculate the body mass index (BMI). Children were categorized as underweight (BMI < 18.5), ideal weight (BMI 18.5–24.9), overweight (BMI 25–29.9), or obese (BMI > 30). The degree of joint hypermobility will be scored by using the Beighton scoring system. The five clinical tests that make up the screening criteria were given a score of 0 or 1 according to the subject’s performance on them. After adding together all of the test results, the total range from 0 to 9. |