| CTRI Number |
CTRI/2021/10/037173 [Registered on: 07/10/2021] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the effect of Mulligan therapy (mobilization technique) with use of spirometer and chest expansion in healthy individuals |
|
Scientific Title of Study
|
“Immediate Effect of Mulligan Therapy on Pulmonary Function and Chest Expansion in Healthy Individuals†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHEETA SARADA |
| Designation |
MPT |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9663090900 |
| Fax |
|
| Email |
harshitasarda28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHASWAT VERMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9886591748 |
| Fax |
|
| Email |
shaswatverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARSHEETA SARADA |
| Designation |
MPT |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
M S RAMAIAH MEDICAL COLLEGE, DEPARTMENT OF PHYSIOTHERAPY, MATHIKERE, BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9663090900 |
| Fax |
|
| Email |
harshitasarda28@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Hospitals, Bangalore |
|
|
Primary Sponsor
|
| Name |
CENTER OF REHABILITATION M S RAMAIAH HOSPITALS |
| Address |
M S RAMAIAH MEDICAL COLLEGE DEPARTMENT OF PHYSIOTHERAPY |
| Type of Sponsor |
Research institution |
|
|
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 |
| HARSHEETA SARADA |
M S RAMAIAH HOSPITALS ,BANGALORE |
BASEMENT FLOOR, CENTER OF REHABILITATION, M S RAMAIAH MEMORIAL HOSPITAL BANGALORE
Bangalore
KARNATAKA |
9663090900
harshitasarda28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S RAMAIAH MEDICAL COLLEGE AND HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MULLUGAN THERAPY WILL BE GIVEN FOR 20 MINUTES. |
20 minutes of therapy including Thoracic SNAGs, intercostal MWM, and MWM for Costochondral and costovertebral joints and pre and post spirometer values and chest expansion will be checked |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
AGE GROUP OF 20-40 YEARS WITH BOTH THE GENDERS |
|
| ExclusionCriteria |
| Details |
• Those diagnosed with neurological findings
• Thoracic surgeries.
• Taking regular medicines to relieve pain.
• Obstructive or Restrictive findings in pretest spirometer.
• Post COVID individuals.
• Chronic Orthopedic related conditions of cervical and lumbar region.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test that is FEV1, FVC, FEV1/FVC, PEF, PIF and Chest expansion at axillary, mammary and xiphisternum |
Pulmonary function test that is FEV1, FVC, FEV1/FVC, PEF, PIF and Chest expansion at axillary, mammary and xiphisternum at baseline and after 20 minutes of therapy including Thoracic SNAGs, intercostal MWM, and MWM for Costochondral and costovertebral joints. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
15/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I Harsheeta Brijmohan Sarada, a post graduate student of physiotherapy in M S Ramaiah Medical College and doing a research titled “IMMEDIATE EFFECT OF MULLIGAN THERAPY ON PULMONARY FUNCTION AND CHEST EXPANSION IN HEALTHY INDIVIDUALS†Under the guidance of Mr. Shaswat Verma and Mrs. Akriti Gupta. This proposal has been reviewed and approved by Institutional Ethics Committee Ramaiah Medical College, which is a committee whose task it is to make sure that research participants are protected from harm. |