FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079455 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
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   Chest Proprioceptive Neuromuscular Facilitation Techniques on Vital Parameters in Mechanically Ventilated Patients  
Scientific Title of Study   Effect of Chest Proprioceptive Neuromuscular Facilitation Techniques on Vital Parameters in Mechanically Ventilated Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Munot 
Designation  Postgraduate Student 
Affiliation  Datta Meghe College of Physiotherapy,Nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  7083239173  
Fax    
Email  nishamunot04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Shukla 
Designation  Professor 
Affiliation  Datta Meghe College of Physiotherapy, Nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9960290614  
Fax    
Email  manish.shukla20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nisha Munot 
Designation  Postgraduate Student 
Affiliation  Datta Meghe College of Physiotherapy, Nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  7083239173  
Fax    
Email  nishamunot04@gmail.com  
 
Source of Monetary or Material Support  
Dr Babasaheb Ambedkar Superspeciality Institute Wanadongri, Hingna Road, Nagpur 441110 Maharashtra India 
 
Primary Sponsor  
Name  Datta Meghe College of PhysiotherapyWanadongri Hingna Road Nagpur Maharashtra India 
Address  Wanadongri, Hingna Road, Nagpur 441110 MAHARASHTRA India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nisha Prashant Munot  Dr Babasaheb Ambedkar Superspeciality Institute  Medicine Intensive Care Unit Ward no 20-21 Dr Babasaheb Ambedkar Superspeciality Institute Wanadongri,Hingna Road, Nagpur 441110
Nagpur
MAHARASHTRA 		 7083239173

nishamunot04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Ayurved, Physiotherapy, Nursing(APN) Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J98||Other respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chest Proprioceptive Neuromuscular Facilitation Techniques  Rhythmic initiation and Initial stretch technique over 4 levels upper and lower chest wall , sternum, below ribcage over diaphragm four stimulations of 90 seconds at each level with 1 minute rest after each technique. 
Comparator Agent  Routine Chest Physiotherapy  Routine Chest Physiotherapy including percussion, vibration and Postural drainage. 3 sets of chest percussion and vibration and 15 minutes of postural drainage.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Mechanically ventilated patients with assist mode of ventilator
2.Hemodynamically stable patients
3.Responsive patients 
 
ExclusionCriteria 
Details  1.Patients with Rib fractures
2.Recent Thoracic, Abdominal or Neurological Surgery
3.Fever over 38.3degree celcius
4.Patients with neurological involvement.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Vital Parameters
1.Heart Rate
2.Oxygen Saturation
3.Respiratory Rate


 		 Pre-treatment,5 minutes and 60 minutes post-treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
Vital Parameters
1.Systolic Blood Pressure
2.Diastolic Blood Pressure 		 Pre-treatment,5 minutes and 60 minutes post-treatment 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   04/02/2025 
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 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 - NO
Brief Summary   In developed countries, the mortality rate of patients on mechanical ventilation is increasing beyond 35% particularly in non-surgical patients requiring frequent ventilation. The incidence rate of patients requiring the mechanical ventilation those admitted in medicine ICU is about 37% in India. A mechanical ventilator is a device that helps patients with respiratory insufficiency breathe by pumping breathable air into and out of their lungs.

This randomized controlled trial aims to explore the effect of chest Proprioceptive Neuromuscular Facilitation (PNF) techniques on vital parameters in mechanically ventilated patients. PNF is a therapeutic approach involving specific movements and positioning to stimulate proprioceptive receptors, potentially improving respiratory function and the overall clinical condition of critically ill patients.

Procedure-

Participants will be selected and screened based on inclusion and exclusion criteria. Details about the study and intervention will be explained to the participant relatives and an informed written consent form will be obtained. Patient’s will be Randomly divided through Block Randomization method into Group A (Interventional) and Group B (Control). Outcomes will be assessed before treatment, 5 minutes and 60 minutes post-treatment and. Data will be collected from both groups and analyzed for significant differences in vital parameters. Statistical tests will be used to assess results of chest proprioceptive neuromuscular facilitation techniques.  
Close