| 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
|
|
|
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
|
|
|
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. |