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CTRI Number  CTRI/2024/03/064495 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy of posture correction with MFR on pulmonary efficiency in patients with kyphosis  
Scientific Title of Study   Efficacy of Posture Correction with MFR on Pulmonary Efficiency in Patients with Kyphosis Deformity  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nidhi Kadian 
Designation  student 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  7206314619  
Fax    
Email  nidhikadian563@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Source of Monetary or Material Support  
Nidhi Kadian BPT student Guru Jambheshwar University of Science and Technology Hisar 
 
Primary Sponsor  
Name  Department of Physiotherapy 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 
Type of Sponsor  Research institution 
 
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 Nidhi Kadian  OPD Department of Physiotherapy  Room No.5 OPD Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA 		 7206314619

nidhikadian563@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of GJUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M400||Postural kyphosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients in this group will perform thoracic exercises for four sessions per week for 3 weeks 
Intervention  Thoracic exercise program with myofascial release  Patients in this group will perform thoracic exercises and will given myofascial release for four sessions per week for 3 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  The kyphosis postural anomaly of more than 42 degree measured by inclinometer.
The participants who are giving informed consent for voluntary participation. 
 
ExclusionCriteria 
Details  A history of fracture, surgery,joint disease in the vertebral column, shoulder girdle or pelvis.
The participants who are unwilling to continue the exercises or absent in two consecutive exercise sessions and absent in measurements sessions. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Forced vital capacity Forced expiratory volume in 1 second 6 minute walk test  The outcome will be assessed for two times which is at the baseline and after 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Kyphosis Angle  The outcome will be assessed for two times which is at the baseline and after the 3 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   28/03/2024 
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="0"
Months="0"
Days="28" 
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   It is a randomised controlled trial with a duration of 3 weeks and involving 30 patients that will be divided into two groups based on lottery method . Its intervention involves thoracic exercise program and myofascial release in one group and only thoracic exercise program in control group . The patient will be informed about the study and written informed consent will be taken . First, each patient’s demographic information including age, height, weight will be gathered as a baseline data. Pre-intervention measurements of outcome variables including Kyphosis angle, Forced expiratory volume in 1 second (FEV1) , Forced vital capacity (FVC) and 6 minutewalk test  will be taken. Interventions will be given for 3 weeks then Post- intervention data of all outcome variables will taken. 
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