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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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