| 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 |
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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 |
|
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Source of Monetary or Material Support
|
|
|
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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
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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. |
|
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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
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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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 |
|
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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 STUDYThe 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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