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CTRI Number  CTRI/2026/02/103718 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Functional electrical stimulation of abdominal musculature in patients following chest trauma: A pilot randomized controlled trial 
Scientific Title of Study   Functional electrical stimulation of abdominal musculature in patients on mechanical ventilation following chest trauma: A pilot feasibility open randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAPIL DEV SONI 
Designation  Professor Critical and Intensive Care  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Jai prakash Narayan apex trauma center, Rajnagar, Ring Road, Safdarjung Enclave, Delhi

South
DELHI
110029
India 
Phone  9718661658  
Fax    
Email  kdsoni111@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  KAPIL DEV SONI 
Designation  Professor Critical and Intensive Care  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Jai prakash Narayan apex trauma center, Rajnagar, Ring Road, Safdarjung Enclave, Delhi

South
DELHI
110029
India 
Phone  9718661658  
Fax    
Email  kdsoni111@aiims.edu  
 
Details of Contact Person
Public Query  
Name  KAPIL DEV SONI 
Designation  Professor Critical and Intensive Care  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Jai prakash Narayan apex trauma center, Rajnagar, Ring Road, Safdarjung Enclave, Delhi

South
DELHI
110029
India 
Phone  9718661658  
Fax    
Email  kdsoni111@aiims.edu  
 
Source of Monetary or Material Support  
JPN Apex Trauma Centre, Rajnagar,Ring road , Safdarjung Enclave,All India Institute of Medical Sciences, New Delhi, 110029 
 
Primary Sponsor  
Name  Kapil Dev Soni 
Address  JPN Apex Trauma Centre, Rajnagar,Ring road , Safdarjung Enclave,All India Institute of Medical Sciences, New Delhi, 110029 
Type of Sponsor  Government medical college 
 
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 
Kapil Dev Soni  JPN Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi  Rajnagar, Ring road, Safdarjung Enclave, Delhi
South
DELHI 		 9718661658

kdsoni111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,All India Institue of Medical Sciences, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S22||Fracture of rib(s), sternum and thoracic spine, (2) ICD-10 Condition: S298||Other specified injuries of thorax,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  functional electrical stimulation of abdominal muscles.  functional electrical Stimulation will be applied via surface electrodes for 30 min, twice per day, 5 days per week (including first 5 days consecutively), until discharge from the ICU.or till the patient is extubated or expired or undergoes abdominal surgical intervention. Electrodes will be placed posterolateral over the abdominal wall designed to activate the rectus abdominus , transversus abdominis and internal and external oblique muscles(abdominal group of muscles) The active group will receive abdominal FES at an intensity that causes a strong visible muscle contraction. The stimulation current in the control group will set at possible sensation but no muscle contraction. 
Comparator Agent  Standard Care without application of effective Functional electrical stimulation.  Stimulation current in the control group will set at possible sensation but no muscle contraction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  age more than 18 years or equal to 18 years.
patients having chest injury.
patients must be dependent on mechanical ventilation due to critical illness. 
 
ExclusionCriteria 
Details  Patients will be excluded if they are expected to be ventilated for less than 24 h or already ventilated for more than 72 h
pregnant
neurological paralysis (e.g. spinal cord injury)
physical obstacles that prevent abdominal FES (e.g. abdominal trauma)
A diagnosed terminal illness
Known morbidly obese.
abdominal surgery within 4 weeks prior to potential inclusion.
Uncooperative patient.
Patients with pacemakers, NMR-Imaging, defibrillators.
Patients with autonomic dysreflexia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Percentage of patients in whom procedure could be done.
2. Ventilator Free Days,
3. ICU Free Days
4. Hospital Free Days
5. Difference in muscle thickness.
6. Percentage of patients showing visible contraction.
7. Difference in muscle thickness.
8. Arrythmias
9. Seizures
10. Hypotension
11. Skin burns
12. Uncooperative patient
Analysis :
 		  
 
Secondary Outcome  
Outcome  TimePoints 
1. Ventilator Free Days,
2. ICU Free Days
3. Hospital Free Days
4. Difference in muscle thickness.
5. Percentage of patients showing visible contraction.

6.Incidence of Arrythmias, Seizures,Hypotension and Skin burns during the procedure
 		  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/03/2026 
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="2"
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  

Functional electrical stimulation (FES) of abdominal musculature in mechanically ventilated patients following chest trauma will be  evaluated in a pilot, feasibility, open randomized controlled trial to determine whether this intervention could improve respiratory outcomes and assist ventilator weaning. Patients with chest trauma requiring mechanical ventilation will be  randomized to receive either standard care alone or standard care plus FES applied to abdominal muscles. The feasibility outcomes included recruitment rate, protocol adherence, safety, and patient tolerance.



 
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