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CTRI Number  CTRI/2025/05/086161 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of scoliosis specific exercises on breathing, posture, and quality of life in adolescents scoliosis 
Scientific Title of Study   Efficacy of SPINAL ARTE CARE SYSTEM Based Scoliosis Specific Exercises on Posture, Respiratory Function and Quality of Life in Adolescents with Idiopathic Scoliosis: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravinder Kumar 
Designation  Head of Department, Department of Physiotherapy 
Affiliation  Savant Hospital 
Address  Prime Spine & Scoliosis, Department of Physiotherapy, 2nd floor, Room no. 1, inside Savant Hospital, Camp chowk, Hisar, Haryana

Hisar
HARYANA
125001
India 
Phone  08901571277  
Fax    
Email  dr.ravi7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sajjan Pal 
Designation  Associate Professor 
Affiliation  SGT, University 
Address  Faculty of Physiotherapy, Room no. 2, D- block, Basement, SGT University, Gurugram

Gurgaon
HARYANA
122505
India 
Phone  09468324923  
Fax    
Email  Sajjanpal_fpt@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Sajjan Pal 
Designation  Associate Professor 
Affiliation  SGT, University 
Address  Faculty of Physiotherapy, Room no. 2, D- block, Basement, SGT University, Gurugram

Gurgaon
HARYANA
122505
India 
Phone  09468324923  
Fax    
Email  Sajjanpal_fpt@sgtuniversity.org  
 
Source of Monetary or Material Support  
Prime Spine & Scoliosis, Department of Physiotherapy, Room no. 1, 2nd floor, inside Savant Hospital, Camp chowk, Hisar, Haryana, India. PIN- 125001 
 
Primary Sponsor  
Name  Ravinder Kumar 
Address  Prime Spine & Scoliosis, Department of Physiotherapy, Room no. 1, 2nd floor, inside Savant Hospital, Camp chowk, Hisar, Haryana, India. PIN-125001 
Type of Sponsor  Other [Self Sponsored] 
 
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 Ravinder KumarPT  Savant Hospital  Prime Spine & Scoliosis, Department of Physiotherapy, Room no 1,2nd floor, inside Savant Hospital, Camp chowk, Hisar, Haryana, India. PIN-125001
Hisar
HARYANA 
08901571277

dr.ravi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Faculty of Physiotherapy, SGT University, Gurugram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coventional exercises  The subjects will receive conventional scoliosis specific exercises. At the baseline visit, they will be advised to follow a home exercise regime. They will be instructed to do the exercises for 30-40minutes, three times a week, 10 repetition/ set, 3sets for 12 weeks3  
Intervention  Scoliosis Specific Exercises   Intervention will include Spinal Arte Care System-based scoliosis-specific exercises along with inspiratory muscle training for 40-50 minutes, three times a week, 10 repetition/ set, 3sets for 12 weeks under the supervision of specialists at the clinic. The exercises will follow the RSRS (Release, Stretch, Release, and Strengthen) protocol.  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Participants with adolescent idiopathic scoliosis
C and S shaped curve scoliosis
Cobbs angle of 10 to 50 degree
Risser grade 0 to 3 and with or without brace 
 
ExclusionCriteria 
Details  Patients with a Cobb angle greater than 50°
Non-idiopathic scoliosis
Neurological or neuromuscular problems, mental problems, trauma-related diseases, congenital anomalies, or previous spinal surgery.
Any chronic upper respiratory diseases affecting the test results
If any red flag signs & symptoms
Unable to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Posture analysis
Respiratory Function: FVC,
FEV1,FEV1/FVC
Peak expiratory flow rate
Quality of life
 

Outcome measures will be assessed at baseline, at the end of the 8th week, and the end of the 12th week of the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   15/05/2025 
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="1"
Months="6"
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  

Adolescent idiopathic scoliosis (AIS) is the most common type of scoliosis with an incidence of 2% in the general population. There are several exercise approaches such as Scoliosis Specific Exercise (SSE) recommended by the Scientific Society on Scoliosis Orthopaedic Rehabilitation and Treatment (SOSORT), Scientific Exercises Approach to Scoliosis (SEAS) Italy, Barcelona Scoliosis Physical Therapy Approach (BASPT), Dobomed (Poland) and Lyon approach (France), confirming the effectiveness of exercises in AIS by improving the rib cage alignment, respiratory function and pelvic balance and bring them to normal anatomical postures but still these need to be confirmed by advance research approaches. In India, None of the studies used respiratory muscle training with exercises to see the changes in posture and respiratory parameters. Hence, the rationale of the present research is to assess the effects of scoliosis-specific exercises under the Spinal Arte Care system on posture, respiratory function, and quality of life in patients suffering from adolescent idiopathic scoliosis.  As now a days, due to poor posture and sedentary lifestyle, scoliosis become a common problem in children. So, newer approaches and techniques have been found out to treat this condition. Thus, from trial the patients will be benefitted by the scoliosis specific exercises and these exercises can be incorporated into their daily lifestyles as lifestyle modification.

  

 
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