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CTRI Number  CTRI/2025/04/085438 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
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   Effect of Chest Physiotherapy on Heart and Blood Flow in ICU Patients with Acute Stroke 
Scientific Title of Study   Immediate Effect of chest proprioceptive neuromuscular facilitation (PNF) and chest wall joint mobilization on hemodynamic status of acute ischemic stroke patients in Intensive care unit (ICU): A comparative 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  Navista 
Designation  PG Student 
Affiliation  SGT University 
Address  Faculty of Physiotherapy SGT University, Chandu, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  7428858990  
Fax    
Email  navishtathree3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aditi 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  faculty of Physiotherapy SGT University, Chandu, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9650878448  
Fax    
Email  aditi_fphy@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Navista 
Designation  PG Student 
Affiliation  SGT University 
Address  Faculty of Physiotherapy SGT University, Chandu, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  7428858990  
Fax    
Email  navishtathree3@gmail.com  
 
Source of Monetary or Material Support  
SGT University, Gurugram, Haryana-122505, India 
 
Primary Sponsor  
Name  Navista 
Address  SGT University, Chandu, Budhera, Gurugram, Haryana-122505 
Type of Sponsor  Other [Self] 
 
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 Aditi  SGT Hoaspital  SICU and MICU In SGT Hospoital Chandu- Budhera Gurugram Haryana-122505
Gurgaon
HARYANA 
9650878448

aditi_fphy@sgtuniversity.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Faculty of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chest proprioceptive neuromuscular facilitation group  Intercostal stretch technique of chest PNF will be applied for 10 second on the paretic side of the body. In this technique the upper boarder of the rib is palpated, uncovering the patient’s chest and the pressure will be applied in downward direction using two fingers. The stretch will be maintained for 10 seconds. Ten repetitions will be given in three sets with a rest period of 1 minute 
Comparator Agent  Chest wall joint mobilization   1. Intercostal Transverse Frictional Massage: This involved applying massage to the intercostal muscles within the third and fourth intercostal spaces while the patient lay on their side. 2.Specific Upper Rib Mobilization: Targeting the upper ribs, the transverse processes of the T5 vertebra were stabilized while a sustained stretch technique, graded at level III, was applied in a ventral-lateral-caudal direction to the rib at the costovertebral region of the T5 vertebra. 3. Specific Lower Rib Mobilization: Focusing on the lower ribs, a similar grade III sustained stretch technique will be employed, this time in a ventral-lateral-cranial direction to the rib at the costovertebral region of the T10 vertebra 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patient age between 40 years and above.
2. Patient with acute ischemic stroke in ICU.
3. Intubated patients.
4. Patients on mechanical ventilation with altered hemodynamic status.
5. Patients with GCS score 11 or less

 
 
ExclusionCriteria 
Details  1.Patients with previous cardiac events or myocardial infarction.
2.Patients with asthma or COPD.
3.Patients with significant abdominal obesity (BMI greater then 28 kg/m2).
4.Previous surgery on chest or abdominal area
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Heart rate, blood pressure, oxygen saturation, respiratory rate, PH, PCO2, PO2, HCO3, BE  Day one assessment 1st week assessment 
 
Secondary Outcome  
Outcome  TimePoints 
chest expansion: 2nd intercostal, 4th intercostal, xiphoid process  Day one assessment 1st week assessment 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   05/05/2025 
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  

 Post stroke brain damage is the common cause of long-term dysfunction in stroke patients. In India the cumulative incidence of stroke ranged from 105 to 152/100,000 persons per year, and the crude prevalence of stroke ranged from 44.29 to 559/100,000 persons in different parts of the country during the past decade . To minimize dysfunction and optimize long-term function, various physiotherapeutic interventions are instituted in acute stage, which help in assisting the neurological, musculoskeletal and cardiorespiratory system.

In acute post injury stage, patients with severe neurological injury are usually intubated with tracheostomy tube, are on mechanical ventilation, given vasoactive support, sedated and is often paralyzed to prevent secondary brain damage due to improper amount of gas exchange. Respiratory complications are most common in neurological insult  like aspiration pneumonia, neurological pulmonary oedema, or as a result of mechanical ventilation and immobilization lead to complication like abnormal breathing pattern and restricted chest wall movement etc.

As respiratory system in stroke patients is affected by because of neurological insult. There is decrease in chest wall movement on paretic side of stroke patients .

There are various physiotherapeutic techniques to improve the respiratory function.  According to literature chest PNF and chest wall joint mobilization are techniques which change rate and depth of breathing and assist in improving muscle activity.

In PNF (Proprioceptive Neuromuscular Facilitation) muscle is stretched passively and constricted alternately. Respiratory neuromuscular facilitation is used to depict externally applied proprioceptive and tactile stimuli that produce reflex respiratory movement response. In healthy individuals, type I and type II fibers are equally numerous in diaphragm, but intercostal muscles have more prevalence of type II fibers. In chest PNF there are various faciliatory stimuli i.e., Intercostal stretch (IC), higher thoracic spine vertebral pressure, lower thoracic spine vertebral pressure, anterior stretch lift to posterior basal area, mild manual pressure, perioral pressure, and abdominal co-contraction are all facilitatory stimuli.

Out of all the facilitatory techniques Intercostal stretching in chest PNF aids in improvement of breathing patterns and respiratory muscle function. Intercostal stretch aid in improving chest wall elevation, chest expansion, and diaphragm excursion, which helps to increase intrathoracic lung volume and high flow rate percentage. Chest PNF can increase ventilation of patients in acute stage of stroke with decreased consciousness. It has been reported that there is an increase in minute ventilation and oxygen saturation after neurophysiological facilitation which is of clinical significance.

Joint mobilization is a manual therapy technique which is used to give passive movements to joint capsules and soft tissue to restore arthrokinematics of the joint. The sustained stretch mobilization is used to increase range of motion as it changes viscoelastic structures. Also, rib cage joint mobilization used clinically as it increases the inspiratory capacity by restoring chest wall movements. Thoracic spine joint mobilization can improve chest expansion , inspiratory muscle strength and pulmonary function.

Joint mobilization when applied to T6 and T12 vertebrae increases the lower trapezius strength due to articular reflexogenic effects. Thus, inspiratory muscle activity may be improved through articular reflexogenic effects of rib cage joint mobilization, increase rib cage flexibility, and increased respiratory muscle length.

 Null hypothesis (H0):  There is no significant difference in the immediate effect on hemodynamic status between chest proprioceptive neuromuscular facilitation (PNF) and chest wall joint mobilization among ischemic stroke patients in the Intensive Care Unit (ICU).

Alternate hypothesis(H1): There is a significant difference in the immediate effect on hemodynamic status between chest proprioceptive neuromuscular facilitation (PNF) and chest wall joint mobilization among ischemic stroke patients in the Intensive Care Unit (ICU).


 
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