| CTRI Number |
CTRI/2018/08/015548 [Registered on: 30/08/2018] Trial Registered Prospectively |
| Last Modified On: |
26/05/2019 |
| 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
|
In this study we will compare two core stabilization exercises in healthy subjects with disturbed activation of transverse abdominis muscle. |
|
Scientific Title of Study
|
Efficacy of core muscle stabilization on recruitment order, lumbar mobility and stability in healthy subjects with altered recruitment of transverse abdominis muscle. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JeyanthiS PT |
| Designation |
Associate professor |
| Affiliation |
University of Delhi |
| Address |
2nd floor, physiotherapy department, Amar jyoti institute of physiotherapy karkardooma,Vikas Marg, New Delhi
Karkardooma,Vikas Marg, New Delhi
East
DELHI
110092
India |
| Phone |
9958158815 |
| Fax |
|
| Email |
jeykrishnan1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JeyanthiS PT |
| Designation |
Associate professor |
| Affiliation |
University of Delhi |
| Address |
2nd floor, physiotherapy department, Amar jyoti institute of physiotherapy karkardooma,Vikas Marg, New Delhi
Karkardooma,Vikas Marg, New Delhi
East
DELHI
110092
India |
| Phone |
9958158815 |
| Fax |
|
| Email |
jeykrishnan1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Kumar PT |
| Designation |
Post graduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
2nd floor, physiotherapy department, Amar jyoti institute of physiotherapy karkardooma,Vikas Marg, New Delhi
Karkardooma,Vikas Marg, New Delhi
East
DELHI
110092
India |
| Phone |
9717978381 |
| Fax |
|
| Email |
shweta22kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF Amar Jyoti Institute of Physiotherapy, karkardooma, New Delhi, 110092 |
|
|
Primary Sponsor
|
| Name |
Amar Jyoti Institute of Physiotherapy |
| Address |
Karkardooma, Vikas marg, New Delhi-110092 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shweta kumar |
Amar Jyoti Institute of Physiotherapy |
Physiotherapy department, 2nd floor, Karkardooma, Vikas Marg, New Delhi
East
DELHI |
9717978381
shweta22kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
58 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
To check efficacy of core muscle stabilization on recruitment order, lumbar mobility and stability in healthy subjects with altered recruitment of transverse abdominis muscle. |
In this study we will check the efficacy of core muscle stabilization exercises on recruitment order of transverse abdominis muscle eg., using Deep muscle contraction scale, lumbar mobility eg., using modified modified schobers test for range of motion of lumbar spine and flexicurve for degree of lumbar lordosis and lumbar stability eg., using pressure biofeedback unit. This study will be done on healthy subjects who will be assessed on the above mentioned parameters. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Students with disturbed recruitment of transverse abdominis with deep muscle contraction score of 7 or less, students willing to participate, students enrolled in delhi colleges and nulliparous females. |
|
| ExclusionCriteria |
| Details |
History of abortion, hernia, abdominal surgery, trauma and tumor, pregnant women,students having back pain. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure biofeedback unit to measure transverse abdominis muscle activity. |
On Day 1 and Day 10 for 2 times it will be tested. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recruitment of transverse abdominis using deep muscle contraction score of 7 or less, measure degree of lumbar lordosis using flexicurve and modified schobers test to measure lumbar spine range of motion. |
On Day 1 and Day 10 for 2 times it will be tested. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2018 |
| Date of Study Completion (India) |
02/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Randomized parallel group trial study which is evaluating the efficacy of core muscle stabilization on recruitment order, lumbar mobility and stability in healthy subjects with altered recruitment of transverse abdominis muscle that will be conducted in Amar Jyoti institute of Physiotherapy, karkardooma, New delhi. Core has been described as a muscular box where the abdominals form the front, paraspinals and gluteals as back, diaphragm as roof and pelvic floor and hip girdle musculature as the bottom. The college students are one of the most vulnerable populations who are subjected to spinal stresses as a result of faulty posture due to course of study, long periods of course work, type of footwear and heavy backpacks. These factors cause fatigue in the abdominal muscles overtime leading to altered recruitment pattern of transverse abdominis muscle in healthy college students. There is emerging evidence of several researches now focusing on correcting the faulty biomechanics of the spine. However, the focus is more centered on transverse abdominis alone whereas co-activation of diaphragm and pelvic floor muscles is also of importance for optimal stabilization of spine. The need of the hour is to develop synchronized approach targeting all three major components diaphragm, pelvic floor and transverse abdominis muscles for optimal stabilization of the spine to prevent injuries and correct muscle recruitment in college students. This study will involve 2 weeks protocol of core muscle exercises for example abdominal drawing in maneuver, 90-90 bridge with balloon and ball and lumbar mobility exercises where the participants will be assessed before and after the protocol on the Primary outcome measure, pressure biofeedback unit and secondary outcome measures, modified modified schober’s test (to assess range of motion of lumbar spine) deep muscle contraction scale and to assess degree of lumbar lordosis using flexicurve. |