| CTRI Number |
CTRI/2025/12/099854 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In our study we will be including patients with blunt thoracic injury of any kind. We will be giving acapella twice a day for removal of excess secretion to see the effect on pain on cough, SpO2 and vitals. |
|
Scientific Title of Study
|
Feasibility of using acapella in stable post traumatic thoracic injury patients for management of excess secretion. A single arm pilot study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshali Nanhe |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Plot no. 106, Pragati Nagar, Ranala,Kamptee
Department of Cardiovascular and Respiratory Physiotherapy,OPD 4,MGM Institute of Physiotherapy
Nagpur
MAHARASHTRA
441001
India |
| Phone |
9356766487 |
| Fax |
|
| Email |
harshalinanhe14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Kapre PT |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
MGM Institute of Physiotherapy,MGM Campus, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9425346903 |
| Fax |
|
| Email |
vaibhavkapre@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Kapre PT |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
MGM Institute of Physiotherapy,MGM Campus, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9425346903 |
| Fax |
|
| Email |
vaibhavkapre@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy and medical hospital |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6, Cidco, Aurangabad, 431003 |
| 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 |
| Dr Harshali Nanhe |
MGM Institute of Physiotherapy |
MGM Institute of Physiotherapy,MGM tertiary care centre,N6, cidco Aurangabad
Aurangabad
MAHARASHTRA |
09356766487
harshalinanhe14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
device acapella |
Acapella will be used for clearing mucus secretion out through expectoration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having blunt thoracic injury
2.Both males and females of 18 years of age |
|
| ExclusionCriteria |
| Details |
1.Patients with unstable vitals
2.Patients on ventilatory support
3.Patient who are unconscious or comatose
4.Patients with higher spinal cord injuries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain on NPRS |
on Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Brethlessness, cough, sputum scale
|
Pre and post intervention till discharge |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
19/01/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
Patients with traumatic thoracic injury will be included in the study trial. The written and oral consent will be taken from the patients and proper procedure will be explained. Demographic data will be noted. Baseline data which includes vitals, pain and frequency of cough will be assessed. The patients will be receiving intervention till the day of discharge from the tertiary care centre. Pursed lip breathing shall be given to the patients followed by 2 to 3 repetitions of acapella. This procedure will be repeated thrice a day. Outcome measure will be taken pre and post intervention duration. Statistical analysis of the collected data will be done. Conclusion will be establised based on the obtained results of the study. |