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CTRI Number  CTRI/2025/12/099856 [Registered on: 26/12/2025] Trial Registered Prospectively
Last Modified On: 25/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of hip and lower back strengthening exercises on pain and balance in people with low back pain and flat feet 
Scientific Title of Study   Effect of gluteal muscle endurance training and lumbar stabilization exercise on pain, lumbar extensor endurance, dynamic balance and EMG activity of gluteal muscle and multifidus on chronic low back pain in individuals with pronated feet: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  Reetuja 
Designation  Post graduate student  
Affiliation  SGT University  
Address  SGT University Room no 420 4th floor Department of Physiotherapy B Block Gurugram Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  07053058881  
Fax    
Email  ritujaghuge@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lalli Singh  
Designation  Assistant Professor 
Affiliation  SGT University 
Address  SGT University Room no 420 4th floor Department of Physiotherapy B Block Gurugram Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  9558386479  
Fax    
Email  singhlalli06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Reetuja 
Designation  Post graduate student  
Affiliation  SGT University 
Address  SGT University Room no 420 4th floor Department of Physiotherapy B Block Gurugram Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  7053058881  
Fax    
Email  ritujaghuge@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Reetuja 
Address  House no 630 Saini Mohalla Near shiv mandir Nangloi New Delhi India 110041 
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 
Reetuja  SGT Hospital and research institue  SGT University Department of physiotherapy Room no 420 b block Gurugram Haryana 122505
Gurgaon
HARYANA 
07053058881

ritujaghuge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee of faculty of physiotherapy, SGT University, Gurugram, Haryana   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Training   Conventional exercise is given to control group where the low back pain exercises are provided for 10 repetitions of 3 sets each  
Intervention  Gluteal muscle endurance training and lumbar stabilization exercise   This exercise intervention is given to the experimental group for the duration of four weeks alternatively (3 sessions in a week) Gluteal muscle endurance training includes hip abduction, clam shell, gluteal bridging hold,glute squeeze etc having 10 repetition of 3 sets each Secondly,Lumbar stabilization exercise includes pelvic tilt, isometric exercises, cat and camel etc having 10 repititon of 3 sets each. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Both males and females
Foot posture index (FPI 6) score range is 6to10
History of having low back pain for 3 or more than 3 months
 
 
ExclusionCriteria 
Details  •History of spinal injury
•Recent lower limb injury
•All neurological conditions affecting balance
•Psychoactive or antihypertensive drug use
•Pregnancy
•Cancer
•Recent foot surgeries
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain
2.Lumbar extensor endurance
3.Dynamic Balance
4.Electromyography activity on gluteal muscles
5.Electromyography activity on multifidus muscles
6.Quality of life 
baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   05/01/2026 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

NEED FOR THE STUDY 

There is a paucity of articles that address the biomechanical dysfunctions contributing to chronic low back pain (CLBP), particularly in individuals with pronated feet. In individuals with pronated feet, the internal rotation of the tibia and femur alters the pelvic tilt, which can lead to compensatory strain on the lumbar extensors and multifidus. While lumbar stabilization exercises are a gold standard, they may not be sufficient if the proximal stabilizers—the gluteal muscles—are fatigued or weak, as they fail to counteract the mechanical deviations caused by foot pronation. There is a lack of high-quality randomized controlled trials that specifically investigate whether combining gluteal endurance training with lumbar stabilization provides a superior effect on neuromuscular control and dynamic balance compared to traditional methods. This study aims to fill this gap by utilizing objective electromyographic (EMG) data to assess how the integrated approach affects muscle recruitment patterns in this specific population.

SIGNIFICANCE OF THE STUDY

The significance of this research lies in its holistic approach to musculoskeletal rehabilitation, moving beyond localized treatment to address the entire lower limb kinetic chain. By identifying the relationship between gluteal endurance and multifidus activity in patients with pronated feet, the findings could fundamentally change clinical assessment protocols for CLBP. If the intervention proves effective, it will provide physical therapists with a more comprehensive, evidence-based exercise framework that improves not just pain scores, but also functional dynamic balance and long-term spinal stability. Furthermore, the use of EMG provides a "window" into the neuromuscular changes occurring, offering objective proof of muscle recovery that can guide more precise rehabilitation timelines. Ultimately, this study aims to enhance the quality of life for individuals with CLBP by addressing the underlying biomechanical triggers often overlooked in standard care.

 
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