| 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
|
|
|
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
|
|
|
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.
|