| CTRI Number |
CTRI/2025/02/080345 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Check for Curved Backbones in School Children and Find Out How Many Have This Problem |
|
Scientific Title of Study
|
Detection of Adolescent Idiopathic Scoliosis (AIS) among School children of Udupi Taluk, Karnataka through the school screening program |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ansuya |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Community Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9535894558 |
| Fax |
|
| Email |
ansuya.bengre@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Ansuya |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Community Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9535894558 |
| Fax |
|
| Email |
ansuya.bengre@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhav Pai |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical Hospital |
| Address |
Department of Orthopedics
Kasturba Medical Hospital
Manipal Academy of Higher Education
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9901729998 |
| Fax |
|
| Email |
madhava.pai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research Funded
Address
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing |
| Address |
Manipal Academy of Higher Education
Manipal
576104 |
| Type of Sponsor |
Research institution |
|
|
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 Ansuya |
Manipal College of Nursing |
Community Health Nursing Department, Manipal Academy of Higher Education
Madhav Nagar,Eshwar Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA |
9535894558
ansuya.bengre@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents of age 10 to 16 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
School children who are willing and consented by parent/ guardian (aged 10 to 16 years) and who can read and write Kannada or English are included in the study |
|
| ExclusionCriteria |
| Details |
School children already diagnosed as scoliosis and on/taken treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Adolescent Idiopathic Scoliosis |
one time |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
23/02/2025 |
| 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="3" Months="0" Days="0" |
|
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
|
Introduction Adolescent idiopathic scoliosis is a spinal deformity that causes the spine to curve sideways in ‘S’ or ‘C’ shape. This study involves screening of school children aged 10 to 16 years. Your child is being invited to participate in this survey study to detect Adolescent Idiopathic Scoliosis through school screening program. This study involves Adam’s forward bending test (AFBT) and use of a scoliometer for screening scoliosis. Education and counseling will be given to the children identified with scoliosis to create awareness about scoliosis, its treatment, and its benefits. Also, the referral services will be provided for the treatment through public or private health insurance /applicable schemes for the treatment. Purpose of the study: The purpose of study is to identify Adolescent idiopathic scoliosis among school children aged 10 to 16 years and to refer the positive cases for further management and to initiate Counselling and education for parents and child. Furthermore, to incorporate research outcome into Rasthriya Bal Swasthya Karyakarama and social insurance. Procedure •Initially, Parents will be contacted for obtaining consent for involve their child in the study during the regular meetings conducted by school. •After obtaining consent from parents and students, School screening will be initiated on the most feasible timing agreed along with school authority by trained personnel in the presence of a female teacher. • On the day of school screening, Back ground information will be collected (minimum time required 2 minutes). Next, physical examination will be done. visually seen the back of the student and measurement are taken individually through structured tool. Privacy and safety will be ensured throughout the screening (minimum time required 10 minutes) and clinical sign proforma will be collected form student who has positive finding (minimum time required 5minutes). Rescreening for positive finding will be done to avoid the possibility of unnecessary referral. • If scoliosis is detected, parents will be informed and separate session will be held to educate and create awareness of their child’s condition and inform treatment options. Further, Further, referral services for the treatment through public or private health insurance /schemes for the treatment will be done. |