| CTRI Number |
CTRI/2025/09/095182 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| 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
|
study to check the difference between two position with a pressure device on hip bone for tight hip and lower back and weak abdomen in young adults |
|
Scientific Title of Study
|
Effect of Abdominal Darwing in maneuver with Pressure biofeedback in Varid position on core muscle endurance & pelvic tilt in young Adults with lower cross syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailee Vipul Patel |
| Designation |
Post Graduate student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
18 physiotherapy department , parul sevashram hospital
P.O Limda Tal waghodia vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9307322595 |
| Fax |
|
| Email |
pshailee2041@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dwija Yagnik |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
18 physiotherapy department , parul sevashram hospital
P.O Limda Tal waghodia vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9909021553 |
| Fax |
|
| Email |
dwija.yagnik74008@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shailee Vipul Patel |
| Designation |
Post Graduate |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
18 physiotherapy department , parul sevashram hospital
P.O Limda Tal waghodia vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9307322595 |
| Fax |
|
| Email |
pshailee2041@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Shailee Vipul Patel |
Parul University |
18 physiotherapy department , parul sevashram hospital
P.O Limda Tal waghodia vadodara
Vadodara
GUJARAT |
09307322595
pshailee2041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
lower cross syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abdominal Drawing in with pressure biofeedback in 90-90- position |
Abdominal Drawing in with pressure biofeedback in 90-90- position three days a week for four week |
| Intervention |
Abdominal Drawing in with pressure biofeedback in supine lying |
Abdominal Drawing in with pressure biofeedback in supine lying in Three days a week for four week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 young adults with low back Pain
2 Individuals experiencing symptoms for at least three months
3 Willingness to participate
4 Participants capable of performing the required ADIM exercises Diagnosed with lower cross syndrome
|
|
| ExclusionCriteria |
| Details |
1 Individuals with other musculoskeletal disorders or systemic diseases affecting the spine.
2 Participants who have undergone spinal or hip surgery in the past six months
3 Presence of neurological conditions that affect muscle function or coordination.
4 Individuals with severe obesity (BMI over 35)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inclinometer for pelvic tilt |
1 at baseline
2 at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 min sit up test for muscle endurance |
1 at baseline
2 at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
12/10/2025 |
| 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="6"
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
|
Lower Cross Syndrome leads to muscle imbalance, weak abdominals, and anterior pelvic tilt, often causing low back pain in young adults. To address this, my study will use the Abdominal Drawing-In Maneuver (ADIM) with pressure biofeedback, a technique known to strengthen core muscles and improve stability. I will divide participants with LCS into two groups—one performing ADIM in a simple supine position and the other in a supine 90-90 position. Both groups will train three times a week for four weeks with stretching and strengthening exercises. Using the 1-minute sit-up test and an inclinometer, I will measure improvements in core muscle endurance and pelvic tilt. Through this, my study aims to identify which position works best to enhance core stability and correct postural imbalance in young adults with Lower cross syndrome |