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CTRI Number  CTRI/2018/05/013689 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On: 02/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Specific exercises for side curve or hunch back seen in childhood  
Scientific Title of Study   Effects of Scientific Exercise Approach to Scoliosis (SEAS) on Idiopathic scoliosis in pre pubertal girls - A Prospective clinical study 
Trial Acronym  SEAS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mudasir Rashid Baba 
Designation  PhD research scholar 
Affiliation  Yenepoya University 
Address  Yenepoya Physiotherapy College Yenepoya University

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7899466841  
Fax  0824-2203689  
Email  mudasirrashid@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr RM Shenoy 
Designation  Professor and HOD Orthopaedics 
Affiliation  Yenepoya University 
Address  Yenepoya Medical College and Hospital Yenepoya University

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845084046  
Fax    
Email  rmshenoy55@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mudasir Rashid Baba 
Designation  PhD research scholar 
Affiliation  Yenepoya University 
Address  Yenepoya Physiotherapy college Yenepoya(Deemed to be University) Deralkatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7899466841  
Fax    
Email  mudasirrashid@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya (Deemed to be university) university Road Deralakatte Mangalore 575018  
 
Primary Sponsor  
Name  Yenepoya University 
Address  University Road Deralakatte Mangalore 
Type of Sponsor  Research institution and hospital 
 
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 
Mudasir Rashid Baba  Yenepoya University  Room no: 1 Department of Orthopaedics YMCH yenepoya Deemed to be university
Dakshina Kannada
KARNATAKA 		 7899466841

mudasirrashid@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Scoliosis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Scientific exercise approach on idiopathic scoliosis( self correction protocol)  •SEAS approach is based on a single word “CONTROL” in which the participants will be encouraged with 4 basic questions and will be asked to apply in their everyday performance of the scientific approach. 1) Relax: To start always with (sitting, standing) position where the spine has an adequate base of support. The first question will be posed is: Am I relaxed or active? 2) Symmetry: Is my trunk more symmetrical than before? 3) Challenge: The exercise will be challenging to your ability to maintain the self correction, am I able to maintain the self corrected posture? Based on the reply, we can understand the level of difficulty of the approach is appropriate. 4) Return: Can I still notice a difference between myself corrected position at the end of the approach and my natural position? Participant should be able to see that her trunk position goes from self corrected posture to usual one for the verification of correctly performed exercises. •The participant will perform the exercise for approximately 10 seconds for each cycle from starting position to returning to the starting position duration: 1 year The clinical evaluation will be performed every 3 months,Curve progression will be monitored and all the measurement will be repeated at regular intervals to assess the progress.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  13.00 Year(s)
Gender  Female 
Details  1. Subjects who are willing to participate in the study
2. Female children studying from the Ist to the 7th standard.
3. Present in school on the day of the screening.
4. Females who haven’t attained the menarche.
5. Idiopathic scoliosis with cob angle less than 15 degree.
 
 
ExclusionCriteria 
Details  1. Subjects with other type of scoliosis e.g. congenital, Neurological etc
2. Subjects who have undergone spinal surgery.
3. Subjects who have altered gait pattern.
4. Subjects who are under conservative management for scoliosis.
5. Schools with girl student population of less than 50.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Screening of idiopathic scoliosis among pre pubertal girls population
 		 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Chance in Posterior trunk symmetry index
2.Change in Angle of trunk rotation
3.Improvement in the health related quality of life
 		 1 year 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)   20/06/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   publication details will be provided which pertain and arise directly out of this trial. Publication of this trial is not yet obtained. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Idiopathic scoliosis is a habitual curvature of spine with unknown aetiology with an approximately of 5% of incidence rate. Prevalence ratio in females is well known. Literature reports have tried to explain the Prevalence in selected populations, possible ways of legacy, related to nutritional deficiency, environmental stress and risk for the progression of curve after puberty which may be a character for the evolution to the irregularity of the spine. SEAS “Scientific Exercise Approach to Scoliosis”, is a potent modern neurophysiologic approach designed to stimulate the reflex and to improve the functioning of spinal musculature. It is employed in idiopathic scoliosis with low-medium degree curves below 20 degree during growth attempting to minimize the progres­sion of Cobb angle. Risk of deterioration is highest during the puberty growth spurt and increases the risk of curvature till skeletal maturity. Various high risk factors predispose the pre pubertal girls for idiopathic scoliosis. Early clinical detection in the age group of 6 to 13 years by non invasive tests can detect early changes. Developing practice guidelines in the form of a simple group activity with due attention to high risk factors may improve the quality of life in children with idiopathic scoliosis which can be followed in school settings as a regular physical activity .No Tran’s cultural version of Scoliosis Research Society (SRS) scale has been used in India for pre and post Scientific Exercise Approach to Scoliosis (SEAS) to evaluate the health related quality of life (HQOL) in pre pubertal girls who are at the risk of idiopathic scoliosis. The aim of this study is to screen early onset of idiopathic scoliosis and evaluate the effect of self-correction approach before the onset of puberty without external aid in group settings with the assistance of trained family members and teachers.

 
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