| 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
|
|
|
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
|
|
|
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). |