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CTRI Number  CTRI/2024/04/065405 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of various exercises program on lower cross syndrome in females after delivery  
Scientific Title of Study   Efficacy of Manual therapy techniques on Lower Cross Syndrome in Postpartum Females: 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  Zeba Yasmin 
Designation  MPT Student 
Affiliation  Guru Jambheshwar University of Science and Technology, Hisar 
Address  Guru Jambheshwar University of Science and Technology, Hisar Room no.07 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana

Hisar
HARYANA
125001
India 
Phone  09518148901  
Fax    
Email  zebayasmin4488@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROFESSOR JASPREET KAUR 
Designation  PROFESSOR 
Affiliation  Guru Jambheshwar University of Science and Technology, Hisar 
Address  Guru Jambheshwar University of Science and Technology, Hisar Room no.07 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana

Hisar
HARYANA
125001
India 
Phone  0  
Fax    
Email  jaspreet.248103@gmail.com  
 
Details of Contact Person
Public Query  
Name  Zeba Yasmin 
Designation  MPT STUDENT  
Affiliation  Guru Jambheshwar University of Science and Technology, Hisar 
Address  Guru Jambheshwar University of Science and Technology, Hisar Room no.07 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana

Hisar
HARYANA
125001
India 
Phone  09518148901  
Fax    
Email  zebayasmin4488@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar,Haryana 125001 
 
Primary Sponsor  
Name  Zeba Yasmin 
Address  Department of Physiotherapy,GJUST,Hisar 
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 
Zeba Yasmin  Guru Jambheshwar University of Science and Technology   Room no. 07,Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA 		 9518148901

zebayasmin4488@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Department of Physiotherapy,GJUST, Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Postpartum females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GroupA-Restorative exercises   Group A will perform restorative exercises 5days/week.Then progression will be added by increasing duration and frequency.  
Intervention  GroupB -Pilates Approach  Group B will perform pilates exercises 5days/week and then progression will be added by increasing duration and frequency. 
Comparator Agent  GroupC- Control Group  GroupC will walk only for 30 minutes 5 days/week.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Age group between 25-35 years
Females with 6 month post delivery
Diagnosed with low back pain 
 
ExclusionCriteria 
Details  Females with back pain due to menstruation or other gynaecological problems.
Having a history of spinal trauma, joint dysfunction or congenital defects.
Acute spasm of Para spinal muscles of back or sprain
of any Para vertebral structures like ligament or fascia.
Those having pain due to any systemic inflammatory disease.
Lumbar radiculopathy
Hip/pelvic surgeries
Antispasmodic medicine
Muscle relaxant 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Low Back Pain
2.Lumbar Lordosis 		 The outcome measures will be assessed at baseline and post intervention (after 6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Anterior Pelvic Tilt
2.Manual Muscle Testing 		 The outcome measures will be assessed at baseline and post intervention (after 6 weeks) 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   Phase 1 
Date of First Enrollment (India)   17/04/2024 
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="3"
Days="15" 
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   Postpartum females usually complain of low backache which leads to difficulty in daily activity tasks. Low Back pain is not only the reason that it adheres to their daily routine, there may also be complications in posture and muscle imbalance occurs that affect their activities of daily living. Poor posture and muscle imbalance causes lower cross syndrome. There is scarcity of literature that shows efficacy of Physiotherapy interventions in postpartum females with lower cross syndrome.Therefore, the present study will be carried out with the aim to find out the efficacy of various manual therapy in postpartum females with lower cross syndrome. 
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