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CTRI Number  CTRI/2017/02/007901 [Registered on: 17/02/2017] Trial Registered Retrospectively
Last Modified On: 08/02/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFECTS OF SPECIFIC EXERCISE PROGRAM ON SCOLIOSIS 
Scientific Title of Study   The effect of task oriented exercises based on ergonomics on adolescent idiopathic scoliosis – Randomized control trial 
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arvind Kumar 
Designation  Lecturer Physiotherapy 
Affiliation  King george medical university, Lucknow, Uttar Pradesh, India 
Address  Arvind Kumar, Lecturer Physiotherapy, Department of physical medicine and rehabilitation, King george medical university, Lucknow, India-226003.
Arvind kumar, 636/48 Asutosh vihar, Takrohi, Indira nagar, Lucknow, Uttar Pradesh, India -226016.
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839410532  
Fax    
Email  arvindmspt@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Santosh Kumar 
Designation  Professor 
Affiliation  King george medical university, Lucknow, Uttar Pradesh, India 
Address  Professor, Department of Orthopedic surgery, King george medical university Lucknow, Uttar Pradesh, India-226003.
Santosh Kumar, Professor, Department of Orthopedic surgery, King george medical university Lucknow, Uttar Pradesh, India-226003. Email. skkgmu69@gmail.com
Lucknow
UTTAR PRADESH
226003
India 
Phone  9415016349  
Fax    
Email  skkgmu69@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arvind Kumar 
Designation  Lecturer Physiotherapy 
Affiliation  King george medical university, Lucknow, Uttar Pradesh, India 
Address  Arvind kumar, Lecturer physiotherapy, Department of PMR, King george medical university Lucknow, Uttar Pradesh, India-226003.
Arvind kumar, Lecturer physiotherapy, Department of PMR, King george medical university Lucknow, Uttar Pradesh, India-226003.
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839410532  
Fax    
Email  arvindmspt@yahoo.in  
 
Source of Monetary or Material Support  
Department of Physical medicine and rehabilitation, Physiotherapy equipments and X-ray, Spirometry. 
 
Primary Sponsor  
Name  KING GEORGE MEDICAL UNIVERSITY LUCKNOWUP 
Address  Department of Physical medicine and rehabilitation, Physiotherapy Unit, King George medical university, Lucknow, UP, India 
Type of Sponsor  Government medical college 
 
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 Arvind Kumar  King George medical university, Lucknow, UP, India  Gandhi memorial and associated hospital, Department of Physical medicine and rehabilitation, Physiotherapy division ,Room no. 2, King George medical university, Lucknow, UP, India
Lucknow
UTTAR PRADESH 		 9839410532

arvindmspt@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional ethics committee, King george medical university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adolescent idiopathic scoliosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Task oriented exercises based on ergonomics  To study the effects of task oriented exercises based on ergonomics on cobbs angle, functional outcome and quality of life in adolescent idiopathic scoliosis 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Subjects in the age group of 10 -15 years
Cases diagnosed as fixed AIS with Cobb’s angle <20 degree for thoracic curves and < 15degrees for thoracolumbar curves
subject with written informed consent 
 
ExclusionCriteria 
Details  Subjects of AIS with correctable deformity
Any pathology and or deformity of lower limbs disturbing spinal posture
Systemic illness or cardio-respiratory dysfunction
Subjects who have undergone spinal surgery or rehabilitation elsewhere
Cognitive impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cobb’s angle,Pulmonary function test, Functional assessment using SF 36, Quality of life estimation by SRS-22.
 		 02 years
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  01 year 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   25/09/2015 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Arvind Kumar, Santosh Kumar, Vikas Verma. Role of postural correction brace along with corrective exercises in improvement of functions and quality of life in adolescent idiopathic scoliosis- randomised controlled trial. J. Evid. Based Med. Healthc. 2016; 3(88), 4813-4818. DOI: 10.18410/jebmh/2016/1014. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is Randomized triple blinded parallel group active controlled trail to find out effects of task oriented exercises based on ergonomics on adolescent idiopathic scoliosis.

Aim of the study is to assess the effect of adding task oriented exercises based on ergonomics on 2 year outcome of mild adolescent idiopathic scoliosis. (defined as curves < 15 for thoracolumbar region and < 20 for lumbar region.)

Hypothesis of the study is including task oriented exercised based on ergonomics will improve outcome in AIS patients with thoracic curves < 20 degrees or thoracolumbar curves < 15 degrees.

 

Objectives and primary outcomes of study are-

1.      To assess the effects on cobb’s angle

2.      To assess the effect on quality of life of patients using scoliosis research society questionnaire-22 (SRS-22)

3.      To assess the effect on activities of daily living using SF 36 (short form 36)

4.      To assess the effect on respiratory function using pulmonary function test and to find out the difference in respiratory functions

Protocol- First 06 months patients enrollment were done following that baseline data were collected then control group is following conventional i.e corrective exercises of spinal scoliosis and experimental group is following task oriented exercises based on ergonomics. Both the groups will be assessed for primary outcomes after one year  and it will be followed by data analysis and result’s conclusion.  
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