| CTRI Number |
CTRI/2024/04/065313 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Controlled Trail To Study The Effect of Proprioceptive Neuromuscular Facilitation as an Adjunct to Chest Physiotherapy on Respiratory Parameters and Weaning Time in Postoperative Oral Cancer Patients on Mechanical Ventilation |
|
Scientific Title of Study
|
Effect of Proprioceptive Neuromuscular Facilitation as an Adjunct to Chest Physiotherapy on Respiratory Parameters and Weaning Time in Postoperative Oral Cancer Patients on Mechanical Ventilation: A Randomized Controlled Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samruddhi Vilas Aherrao |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department Of Cardiorespiratory Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research (Deemed to be University), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620928795 |
| Fax |
|
| Email |
samruddhiaherrai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lajwanti Lalwani |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department Of Cardiorespiratory Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research (Deemed to be University), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605234269 |
| Fax |
|
| Email |
drlalwanilajwanti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lajwanti Lalwani |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department Of Cardiorespiratory Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research (Deemed to be University), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605234269 |
| Fax |
|
| Email |
drlalwanilajwanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College
Oral cancer ICU in Siddhant Gupta Cancer hospital, Sawangi (Meghe), Wardha, Maharashtra India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department Of Cardiorespiratory Physiotherapy, Ravi Nair Physiotherapy College Datta Meghe Institute Of Higher Education And Research(DU) Sawangi (Meghe) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSamruddhi Vilas Aherrao |
Oral cancer ICU in Siddhant Gupta Cancer hospital, Sawangi (Meghe), Wardha, India. |
Department of Cardiorespirtory Physiotherapy
Datta Meghe Institute of Higher Education and Research(DU) Sawangi(Meghe)
Wardha
MAHARASHTRA |
7620928795
samruddhiaherrai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chest Physiotherapy |
Maximum around 10-15 min At the beginning of the postoperative, the patient should be haemodynamically stable and percussion and vibrations are given with repetation 2-3 sets. of 3 sets. The intervention will be held for 2 weeks |
| Intervention |
Proprioceptive neuromuscular facilitation with chest physiotherapy |
Both the groups will receive the routine postoperative physiotherapy protocol involving, chest physiotherapy i.e percussion and vibration and Proprioceptive neuromuscular facilitation, and active exercise for upper and lower limbs, bed mobility and early ambulation training. Along with this the treatment will be held for 2 weeks for twice day for 25-30 mins per session
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants on mechanically ventilator undergoing tracheostomy
2.Hemodynamically stable patients
|
|
| ExclusionCriteria |
| Details |
1. Rib fracture
2. Chest trauma
3. Thoracic vertebrae fracture
4. Cardiac surgery
5. Neurological impairment
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Weaning Time
2.Oxygenation index |
outcome will be assessed at baselines and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dynamic Compliance
2. Quality of life |
outcome will be assessed at baselines and after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/04/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To find out The Effect of Proprioceptive neuromuscular facilitation as an adjunct to chest physiotherapy against chest physiotherapy alone on improving respiratory parametres and weaning time in postoperative oral cancers patients.
1. To evaluate The Effect of Proprioceptive neuromuscular facilitation as an adjunct to chest physiotherapy against chest physiotherapy alone on Weaning time,Oxygenation ratio, Adverse events &QOL in Postoperative oral cancer patients.
|