| CTRI Number |
CTRI/2023/06/054586 [Registered on: 30/06/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| 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
|
Effect of Breathing Training on Sitting Balance and Lung Function in people with Spinal Cord Injury |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Seated Balance and Respiratory Function in people 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 |
Kanishka |
| Designation |
MPT Student |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector - C, Vasant Kunj
New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
8076810792 |
| Fax |
|
| Email |
kanishkagambhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanishka |
| Designation |
MPT Student |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector - C, Vasant Kunj
New Delhi - 110070
DELHI
110070
India |
| Phone |
8076810792 |
| Fax |
|
| Email |
kanishkagambhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shambhovi Mitra |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector - C, Vasant Kunj
New Delhi - 110070
South West
DELHI
110070
India |
| Phone |
9711968166 |
| 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 - Institute of Rehabilitation Sciences |
| Address |
Sector-C, Vasant Kunj, New Delhi - 110070 |
| 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 |
| Kanishka Gambhir |
Indian Spinal Injuries Centre |
Sector C, Vasant Kunj, New Delhi-110070
South West
DELHI |
8076810792
kanishkagambhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Incentive spirometry |
Training using Incentive spirometer for 4 days a week for 6 weeks. |
| Intervention |
Inspiratory muscle training |
Inspiratory muscle training will be given via a flow-resistive inspiratory muscle trainer (PrO2Fit) for 4 days a week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute traumatic spinal cord injury (less than 1 year since injury)
Spinal cord injury of level C4 to T6
ASIA grade A, B or C
Patients who are not receiving mechanical ventilation |
|
| ExclusionCriteria |
| Details |
Tracheostomy
Subjects with diagnosed pulmonary conditions like asthma, COPD, etc.
Subjects with diagnosed head injury or neurological diseases other than spinal cord injury
Visual or auditory impairment which may interfere with participation |
|
|
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 |
| Seated Balance using Function in Sitting Test-Spinal Cord Injury (FIST-SCI) |
T0- at the time of allocation
T1- after 4 weeks of training
T2- after 6 weeks of training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory function using Maximal Inspiratory Pressure (MIP), Sustained Maximal Inspiratory Pressure (SMIP) & Total Power (TP) |
T0- at the time of allocation
T1- after 4 weeks of training
T2- after 6 weeks of training |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
31/07/2023 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomised, double-blind, parallel group, single-centre trial to determine the effect of inspiratory muscle training on the seated balance and respiratory function in individuals with Spinal cord injury. Individuals will be randomly assigned to intervention or comparator groups. Training to intervention group will be given via flow-resistive IMT (PrO2Fit) while comparator group will recieve training via incentive spirometer for 4 days a week for a period of 6 weeks. Assessment of seated balance will be done using FIST-SCI scale and respiratory function will be assessed by MIP, SMIP and total power. Assessment will be done at the time of allocation and at the end of fourth and sixth week of training. |