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CTRI Number  CTRI/2025/09/095462 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
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   Improving Breathing Using Breathing Training And Abdominal Stimulation In Individuals With Spinal Cor Injury 
Scientific Title of Study   Combined Effect Of Abdominal Functional Electrical Stimulation And Inspiratory Muscle Training On Respiratory Function In Individuals With Spinal Cord Injury 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manpreet Kaur  
Designation  Mpt Cardiopulmonary Student  
Affiliation  Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences  
Address  Indian Spinal Injuries Center - Institute Of Rehabilitation Sciences. PMR Department Sector - C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9560787076  
Fax    
Email  mannpreetkaur03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manpreet Kaur  
Designation  Mpt Cardiopulmonary Student  
Affiliation  Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences  
Address  Indian Spinal Injuries Center - Institute Of Rehabilitation Sciences. PMR Department Sector - C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9560787076  
Fax    
Email  mannpreetkaur03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shambhovi Mitra 
Designation  Associate Professor 
Affiliation  Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences  
Address  Indian Spinal Injuries Center - Institute Of Rehabilitation Sciences. 2nd Floor Sector - C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9711968166  
Fax    
Email  shams.physio@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Center - Institute Of Rehabilitation Sciences Sector - C, Vasant Kunj New Delhi - 110070 
 
Primary Sponsor  
Name  Indian Spinal Injuries Center Institute Of Rehabilitation Sciences 
Address  Sector - C, Vasant Kunj, New Delhi  
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 Manpreet Kaur   Indian Spinal Injuries Center And Institute Of Rehabilitation Sciences   Sector - C, Vasant Kunj New Delhi - 110070
South West
DELHI 		 9560787076

mannpreetkaur03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G95||Other and unspecified diseases ofspinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Respiratory muscle training With Electrical Stimulation  Inspiratory Muscle Training And Abdominal Functional Electrical Stimulation For 3-4 Sessions Per Week In Span Of 3-4 Weeks. 
Comparator Agent  Sham Inspiratory Muscle Training And Sham Abdominal Functional Electrical Stimulation   Sham Inspiratory Muscle Training And Sham Abdominal Functional Electrical Stimulation For 3-4 Sessions Per Week In Span Of 3-4 Weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  AIS A ,B And C.

Level Of Injury - C4-T6. 
 
ExclusionCriteria 
Details  Any Clinically Diagnosed Neurological Disorder Other Than SCI

Any Other Pre-diagnosed Respiratory Conditions Like COPD, Asthma Etc.

Individuals On Mechanical Ventilation

Individuals With Any Skin Conditions Which Deter The Application Of Electrical Stimulation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peak Expiratory Flow   T0 - at the time of allocation.
T1- after completion of 6 sessions.
T2- after completion of all 12 sessions. 
 
Secondary Outcome  
Outcome  TimePoints 
Respiratory function using Maximal Inspiratory Pressure (MIP), Sustained Maximal Inspiratory Pressure (SMIP), Total power And Fatigue Index Test (FIT)  T0 - at the time of allocation.
T1- after completion of 6 sessions.
T2- after completion of all 12 sessions. 
Feasibility Outcomes - Safety, Satisfaction And Adherence.  at the end of each session  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   10/10/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response (Others) -  in case required by publication journal for supplementary attachment

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  proposals should be directed to [the editor of publishing journal]

  6. For how long will this data be available start date provided 30-08-0026 and end date provided 30-08-0031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is randomised, double blinded, parallel group, single centre trial, examines the combined effect of Abdominal Functional Electrical Stimulation (FES) and Inspiratory Muscle Training (IMT) on respiratory function in individuals with spinal cord injury (SCI). Individuals will be Randomly assigned to intervention and comparator groups. Training to interventional group will be given via flow resistive IMT (Pro2Fit) along with Abdominal Functional Electrical Stimulation While Comparator group will receive sham training of both interventions (IMT And Abdominal FES) for 3 to 4 days a week for a period of 3 to 4 weeks (total 12 sessions). Assessment of respiratory function will be done - Maximal inspiratory pressure (MIP), Sustained Maximal inspiratory pressure (SMIP), Total power, Fatigue index test (FIT). Assessment of Feasibility parameters - Safety, Satisfaction and Adherence. Assessment of these parameters at time of allocation, after completion of 6 sessions the after completion of total 12 sessions will be done. 
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