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CTRI Number  CTRI/2025/01/079329 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Creating an Affordable Device to Improve and Measure Breathing Strength in spinal cord injury  
Scientific Title of Study   Development of a respiratory function assessment and rehabilitation device for participants 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  Shambhovi Mitra 
Designation  Associate Professor  
Affiliation  Indian Spinal injuries centre 
Address  Clinical Research Department, 1st Floor , Indian Spinal Injuires Centre, Sector -C, vasant Kunj

New Delhi
DELHI
110070
India 
Phone  09711968166  
Fax    
Email  shams.physio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shambhovi Mitra 
Designation  Associate Professor  
Affiliation  Indian Spinal injuries centre 
Address  Clinical Research Department, 1st Floor, Indian Spinal Injuires Centre, Sector -C, vasant Kunj

New Delhi
DELHI
110070
India 
Phone  09711968166  
Fax    
Email  shams.physio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shambhovi Mitra 
Designation  Associate Professor  
Affiliation  Indian Spinal injuries centre 
Address  Clinical Research Department, 1st Floor, Indian Spinal Injuires Centre, Sector -C, vasant Kunj

New Delhi
DELHI
110070
India 
Phone  09711968166  
Fax    
Email  shams.physio@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre, Sector C, Vasant Kunj, New Delhi -110070  
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre 
Address  Sector C, Vasant Kunj , New Delhi -110070 
Type of Sponsor  Private hospital/clinic 
 
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 Shambhovi Mitra   Indian Spinal Injuries Centre  Clinical Research Department, 1st Floor, Indian Spinal Injuires Centre, Sector -C, vasant Kunj
New Delhi
DELHI 
9711968166

shams.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INSPIRATORY MUSCLE TRAINING   5 times per week for 6 weeks 
Intervention  Low cost respiratory muscle training   5 times per week for 6 weeks following a TIRE protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age between 18 – 60 years
Traumatic complete lesion ( AIS A or B)
Individuals between C4-T6 level of injury
Non-Mechanically ventilated patients
 
 
ExclusionCriteria 
Details  Any participant with diagnosed neurological disease other than spinal cord injury and pulmonary disease
Patient on tracheostomy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maximal Inspiratory pressure
 
0 week and 6 week  
 
Secondary Outcome  
Outcome  TimePoints 
MAximal expiratory pressure   0 week and 6 week  
 
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)   10/02/2025 
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)
Modification(s)  
Not Applicable 
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  

People with spinal cord injury face respiratory compromise due to loss of innervation to the primary muscles of respiration. The weakness in respiratory muscles predisposes to a deterioration in pulmonary function in the spinal cord injury population due to weakened cough effort secondary to weakness of respiratory muscles and secretion stagnation. In the acute phase of injury, the flaccid muscles of the chest wall exhibit paradoxical in drawing with pressure changes in the thorax. This increases the risk of acute respiratory failure, atelectasis, pneumonia and other pulmonary infections. The degree of impairment depends on the neurological level of injury, the completeness of the injury and the time since the injury. Inspiratory muscle training has emerged as a promising tool in the respiratory rehabilitation of persons with SCI. A review article advocated the early incorporation of inspiratory muscle training (IMT) show significant improvements in the respiratory muscle strength and to an extent may be helpful for preventing respiratory complications. The literature mostly included hospital-based intervention for IMT. Literature has highlighted the fact that respiratory complications are a major contributor to re-admissions in chronic SCI. The assessment of respiratory muscle strength post injury is a major predictor of respiratory complications.

IMT being such a crucial part of the rehabilitation become a monotonous training without frequent reassessments. There is a need for a way of providing IMT training to individuals, including regular reassessment and alteration in level of training accordingly. A pilot study did examine the feasibility of a game-based approach for breathing exercises. The preliminary results have been promising with significant improvement in pulmonary functions. The lacunae of reassessment of the respiratory muscle strength in the app-based training persisted. Thus, the current study aims to provide a technology based IMT training and assessment for people with spinal cord injury. 

 
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