| CTRI Number |
CTRI/2021/09/036910 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of mulligan mobilization and soft tissue release on diaphragm excursion in mild to moderate asthma |
|
Scientific Title of Study
|
Effect of thoracic mulligan mobilization with Soft tissue release on respiratory parameters including diaphragmatic excursion on motion ultrasound and quality of life in mild to moderate asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuja Bankar |
| Designation |
PG student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
203,Prachi oaks,Shivbasava nagar
JNMC Campus, Nehrunagar, Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
09604834955 |
| Fax |
|
| Email |
anuja2996bankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Orthopaedic Manual Therapy, KAHER Institute of Physiotherapy,JNMC Campus, Nehrunagar, Belagavi,Karnataka
KAHER Institute of Physiotherapy,JNMC Campus, Nehrunagar, Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anuja Bankar |
| Designation |
PG student |
| Affiliation |
|
| Address |
Department of Orthopaedic Manual Therapy,KAHER Institute of Physiotherapy,JNMC Campus, Nehrunagar, Belagavi,Karnataka
KAHER Institute of Physiotherapy,JNMC Campus, Nehrunagar, Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9604834955 |
| Fax |
|
| Email |
anuja2996bankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr. Prabhakar Kore hospital and research centre,Nehru nagar,Belgaum |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
J. N. Medical college campus, Nehru nagar,Belgaum,590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anuja Bankar |
KAHER Institute of Physiotherapy |
J. N. Medical college campus,Nehru nagar,Belgaum,Karnataka,590010
Belgaum
KARNATAKA |
09604834955
anuja2996bankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee(KAHER Institute of Physiotherapy) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan mobilization and Soft tissue release |
Participants will receive Mulligan mobilization and Soft tissue release for 9 sessions 3days/week for 3 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
Mild Asthma: Peak expiratory flow >90% of normal
Moderate asthma: Peak expiratory flow 80- 90% of normal
Medically stable
Willingness to participate |
|
| ExclusionCriteria |
| Details |
Other respiratory and cardiovascular disorders
Presence of other thoracic cage or upper limb neurological,musculoskeletal or autoimmune condition
Metabolic bone disorders
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Motion ultrasound
Peak flow meter
SF 36 Questionnaire
Chest expansion tape measurement |
Pre and post assessment willing be taken on day 1 and after 3 weeks and total 9 sessions of thoracic Mulligan mobilization and soft tissue release |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
07/10/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the effect of Thoracic Mulligan mobilization and Soft tissue release on Respiratory parameters and Quality of life in participants with mild to moderate asthma. To evaluate the effect of Thoracic Mulligan mobilization and Soft tissue release on Respiratory parameters and Quality of life in terms of Peak expiratory flow using Peak expiratory flow meter, Diaphragmatic excursion using motion ultrasound, Chest expansion using Inch tape and Quality of life using SF 36 questionnaire in participants with mild to moderate asthma. Pre and post intervention assessment will be taken with the help of outcome measures. |