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CTRI Number  CTRI/2022/02/040635 [Registered on: 25/02/2022] Trial Registered Prospectively
Last Modified On: 24/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   A Research study on the effect of an exercise program in people with lateral curvature of spine 
Scientific Title of Study   Outcome study on the impact of an integrated exercise program in patients with Adolescent Idiopathic Scoliosis(AIS). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujata Maharathi 
Designation  Ph.D. Student 
Affiliation  Nizams Institute of Medical Sciences Hyderabad 
Address  OPD Block,Room no-30 Department of Orthopaedics Nizams Institute of Medical Sciences,Panjagutta,Hyderabad-500082
Department of Orthopaedics Nizams Institute of Medical Sciences,Panjagutta,Hyderabad-500082
Hyderabad
TELANGANA
500082
India 
Phone  09348953701  
Fax    
Email  sujataphysio74@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raju Iyengar 
Designation  Professor and HOD 
Affiliation  Nizams Institute of Medical Sciences Hyderabad 
Address  Department of Orthopaedics Nizams Institute of Medical sciences Panjagutta,Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9985811481  
Fax    
Email  rajuayengar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Sujata Maharathi 
Designation  Ph.D. Student 
Affiliation  Nizams Institute of Medical Sciences Hyderabad 
Address  OPD Block,Room no-30 Department of Orthopaedics Nizams Institute of Medical Sciences, Panjagutta,Hyderabad-500082
Department of Orthopaedics Nizams Institute of Medical Sciences,Panjagutta,Hyderabad-500082
Hyderabad
TELANGANA
500082
India 
Phone  09348953701  
Fax    
Email  sujataphysio74@gmail.com  
 
Source of Monetary or Material Support  
Nizams Institute of Medical Sciences Hyderabad 
 
Primary Sponsor  
Name  Sujata Maharathi 
Address  Department Of Orthopaedics Nizams Institute of Medical Sciences Panjagutta Hyderabad 
Type of Sponsor  Other [(self)] 
 
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 
Sujata Maharathi  Nizams Institute of Medical Sciences  Department Of Orthopaedics OPD Block Room No-30
Hyderabad
TELANGANA 		 09348953701

sujataphysio74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M411||Juvenile and adolescent idiopathicscoliosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Exercise Program for Adolescent Idiopathic Scoliosis subjects.  Integrated Exercise program consists of selected(1)Breathing Techniques(2)Aerobics Exercises (3)Myofascial release (4)Muscle Energy Techniques(5)Pilates Technique (6)Biomechanically designed specific corrective Exercises, Freequency of Therapy-Institutional based therapy of 2 hourly session twice a week,and home exercise program on other 4 days a week as demonstrated in the log book for First 6 months.The next 6 months therapy freequency will be reduced to once per month, The total duration of therapeutic intervention will be 1 year.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Male or female subjects diagnosed with Adolescent Idiopathic Scoliosis of age 10 years to 40 years who have not undergone any prior conservative or surgical treatment for scoliosis.  
 
ExclusionCriteria 
Details  Infantile and Juvenile scoliosis,Muscular Dystrophy,Congenital scoliosis,Other Neuromuscular Scolioses like Cerebral palsy and Myelomeningocele,Mental Retardation ,Osteogenesis Imperfecta. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Cobb angle,angle of trunk rotation,Spine ROM of flexion and extension,VAS measure for pain.  At pre intervention,and 6 month ,1 year post intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Angle of Lumbar Lordosis,Angle of thoracic kyphosis ,Respiratory function measures like FEV1 and PEF.  At pre intervention,6 months and 1 year post intervention. 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   02/03/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sujataphysio74@gmail.com].

  6. For how long will this data be available start date provided 04-07-2023 and end date provided 04-05-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary    Adolescent Idiopathic Scoliosis is a three -dimensional deformity of spine with a visible lateral curvature of spine and a rib hump which are clinical manifestations of the lateral tilt of vertebrae in the coronal plane and rotation in the transverse plane. The accompanying sagittal plane abnormality due to the anterior or posterior translation can produce obliteration of thoracic kyphosis and lumbar lordosis which are often the associated x-ray findings along with a lateral curvature. The deformity also distorts the rib cage and pelvis, position of shoulder girdle altering the length tension relation of limb and spinal muscles affecting their mobility and function.   The deformity of AIS is managed non-surgically if the Cobb angle is less than 40 o. Physiotherapeutic scoliosis specific exercises have proved their effectiveness in improving the functional parameters, fitness, posture, ergonomics, bone density and health related quality of life, reducing pain, respiratory dysfunction, and curve severity in terms of Cobb angle in growing adolescents and young adults including adult patients with adolescent idiopathic scoliosis The non-surgical standard of care in India is Bracing, observation and general mobility and strengthening exercises only which is not helpful to straighten a curve. As the deformity produces asymmetrical spine, specific asymmetrical exercises can correct a specific curve which is designed biomechanically. Evidence shows small and moderate curves can be managed by curve specific exercises and help to stabilize a curve from progression during adulthood. Many subjects with bigger curves also avoid surgery for many reasons like fear of surgery, affordability and family situation and suffer with the trauma of physical impairment, pain and disability. The present study aims to observe the impact of an integrated exercise program of Myofascial release technique, Muscle energy technique, Pilates Technique and some specifically designed techniques based on the biomechanics of mal aligned spine. Based on the prevalence of scoliosis (1.34%), the sample size consists of 22 subjects of both gender from 10 years to 40 years. The selected exercises from each technique along with some new exercises form the integrated exercise program. The intervention consists of Institutional based Physiotherapy twice a week for first 6 months, once in a month for the next 6 months and daily session of 1 hour home exercise program as demonstrated in the log book. The subjects will be assessed for the primary and secondary outcome parameters on the 1st day before intervention, 6 month and 1 year post intervention.  The Pre-intervention and post -intervention data collected will be analyzed  by Students T -test. The purpose of the study is to strengthen the evidence base in favor of specific exercises in the treatment of idiopathic Scoliosis subjects. Considering the standard of nonsurgical scoliotic management in India, there is a need for this type of study.

  
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