| CTRI Number |
CTRI/2024/05/066918 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Immediate effects of high velocity thrust in individuals with breathing dysfunction. |
|
Scientific Title of Study
|
Immediate effects of high velocity low amplitude thrust of thoracic spine and ribs on respiratory parameters in individuals with breathing dysfunction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janhvi Shinde |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Sciences department, 3rd floor Sant Tukaram Nagar Pimpri, Pune, Maharashtra, 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7400176003 |
| Fax |
|
| Email |
jshinde0113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurang Baxi |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Sciences department, 3rd floor Sant Tukaram Nagar Pimpri, Pune, Maharashtra, 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9371007824 |
| Fax |
|
| Email |
gaurangbaxi82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurang Baxi |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences department,
3rd floor Sant Tukaram Nagar,
Pimpri, Pune 411018
Maharashtra,
Pune
MAHARASHTRA
411018
India |
| Phone |
9371007824 |
| Fax |
|
| Email |
gaurangbaxi82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Sciences |
|
|
Primary Sponsor
|
| Name |
Janhvi Shinde |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences department,
3rd floor,
Sant Tukaram Nagar,
Pimpri, Pune 411018,
Maharashtra. |
| 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 |
| Janhvi Shinde |
Dr. D. Y. Patil College of Physiotherapy, Pune |
Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Sciences department, 3rd floor, Sant Tukaram Nagar Pimpri, Pune, Maharashtra, 411018
Pune
MAHARASHTRA |
7400176003
jshinde0113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional_Ethics_Committee_of_Dr_DY_Patil_College_of_Physiotherapy_Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for any kind of subclinical breathing dysfunction. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High velocity low amplitude thrust manipulation to thoracic spine and ribs. |
1. The individual will be asked to adopt prone position on the couch with face turned to either one side.
2. During exhalation, a single High velocity low amplitude thrust manipulation will be given to thoracic spine and ribs.
3. The thrust will be given only once to the thoracic spine and ribs.
4. Outcome measures will be assessed prior to and immediately after the manipulation. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with breathing dysfunction, having score greater than 11 on Self Evaluation On Breathing Questionnaire [SEBQ]
|
|
| ExclusionCriteria |
| Details |
Any respiratory or cardiac disease
Previous h/o rib fracture, dislocation, sprains of costochondral, costosternal and interchondral joints.
General contraindications for mobilization (primary and secondary neoplastic lesions of spine and/or ribs.
Psychological conditions
Individuals taking any pain medications.
History of ankylosis spondylitis
Obvious advanced spinal deformity, e.g. kyphoscoliosis,
Healing fracture or dislocation, infections, e.g. TB, Non-neoplastic bone diseases
Any Spinal or Lower limb surgery
Any cervical pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pulmonary function test
2.Breath Holding Test
|
1.Prior to HVT manipulation
2.Immediately after HVT manipulation
(immediate Pre and Post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chest wall expansion |
1.Prior to HVT manipulation
2.Immediately after HVT manipulation
(immediate Pre & Post intervention) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/05/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - By contacting PI
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study is Single Arm Quasi Experimental study, studying the effects of high velocity low amplitude thrust on thoracic spine and ribs on respiratory parameters in individuals with breathing dysfunction. The study includes 40 individuals of age group 19 to 25 years and having a score greater than 11 on SEBQ [Self Evaluating Breathing Questionnaire]. The high velocity thrust will be given to the individuals and their immediate effects will be assessed pre and post treatment using pulmonary function test, breath hold test, chest wall expansion. |