| CTRI Number |
CTRI/2024/02/062507 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Breather Device versus Inspiratory Muscle Training for Improved Trunk Stability in Spinal Cord Injury Survivors: A Randomized Controlled Study |
|
Scientific Title of Study
|
Effectiveness of Resistive Respiratory Training using Breather Device Versus Inspiratory Muscle Training in Enhancing the Trunk Stability among Spinal cord Injury Survivors: A Randomized Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rinku Roshan |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Mullers Court Apartments, Bejai New Road, Anegundi Junction, Mangalore.
Father Muller Road, Kankanadi, Mangalore 575002
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09945935788 |
| Fax |
|
| Email |
rinkurosh777@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rinku Roshan |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Mullers Court Apartment, Bejai New Road, Anegundi Junction, Mangalore
Father Muller Road, Kankanadi, Mangalore 575002
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09945935788 |
| Fax |
|
| Email |
rinkurosh777@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Rinku Roshan |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Mullers Court Apartment, Bejai New Road, Anegundi Junction, Mangalore
Father Muller Road, Kankanadi, Mangalore 575002
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09945935788 |
| Fax |
|
| Email |
rinkurosh777@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Janardhana Aithala P |
| Address |
Professor, and HOD Of Orthopaedics, Yenepoya Deemed To Be University, Derlakatte |
| 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 |
| Dr Mrinal B Shetty |
Father Muller Medical College |
Father Muller Road, Kankanadi, Mangalore
Dakshina Kannada
KARNATAKA |
9591288798
drmrinalshetty@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC) |
Approved |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G958||Other specified diseases of spinalcord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breather |
The resistive respiratory muscle training using the BREATHER will involve 20 minutes, twice daily, six times a week for three weeks, along with trunk stabilization exercises for
20 minutes, twice daily, six times a week for three weeks. |
| Comparator Agent |
Inspiratory Muscle Training(IMT) |
The resistive respiratory muscle training using the INSPIRATORY MUSCLE TRAINING will involve 20 minutes, twice daily, six times a week, and trunk stabilization exercises for 20 minutes, twice daily, six times a week for three weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants must be between the ages of 18 and 50 and have traumatic paraplegia
resulting from a spinal cord injury at the neurological level of T1-T7.
2 ASIA scale A and B
3 Spinal cord injury survivors with a sitting balance score of ≤ 1 on the trunk control test.
(TCT)
4 Participants must be at least 15 days post-surgery and medically stable. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if;
1 Traumatic Brain Injury.
2 The individuals are not able to follow the instructions.
3 Traumatic pneumothorax that has not fully healed.
4 Burst eardrum or other conditions of the eardrum.
5 Unstable asthma with an abnormally low perception of dyspnoea.
6 Major fractures in the lower limb like the Pelvis and long bones.
7 Neuromuscular disorders.
8 Preexisting neurological disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Thickness of Diaphragm and Rectus abdominis muscle.
2. Sitting Balance: Sitting balance Measure and Lord Sway meter. |
At the baseline of the study and upon completion of the 3-week evaluation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life: Spinal cord independence Measure. |
Upon completion of 3 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/02/2024 |
| 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="3"
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
Modification(s)
|
The study aims to investigate the impact of expiratory muscle training and trunk stabilization on sitting balance and quality of life in individuals with spinal cord injuries, specifically those with neurological levels of T1 to T7. The research will recruit 68 participants set at 10% attrition with each group having 34 participants. The research will commence after obtaining ethical clearance and registration with the Clinical Trials Registry of India (CTRI). The preliminary phase involves a pilot study with spinal cord injury survivors aged 18 to 50, having injuries from T1 to T7, with a minimum post-surgery recovery period of 15 days.
To assess initial sitting balance, the Trunk Control Test (TCT) will be conducted, and participants scoring ≤ 1 on the TCT will be included. Respiratory muscle strength, sitting balance, and quality of life will be evaluated using ultrasound sonography, sitting balance measurement (SBM), and the Spinal Cord Independence Measure (SCIM), respectively, as baseline assessments.
Two intervention groups, Group A and Group B, will undergo respiratory muscle training using the Respiratory Muscle Trainer (RMT) Breather and Threshold inspiratory muscle training, respectively. The protocol includes 20 minutes of RMT usage and trunk stabilization exercises, twice daily, six times a week for three weeks.
After the intervention, respiratory muscle strength, sitting balance, and quality of life will be reassessed. Upper-body sway will be measured using a modified Lord sway meter, and the study will focus on three components: maximal lateral displacement, maximal anterior-posterior displacement, and the total length of the sway path.
Preliminary results from the acute, chronic, and high T1-T7 level of injury groups indicate variations in sway path lengths and displacements. Quality of life improvements will be specifically evaluated in terms of enhanced trunk stability and sitting balance.
In summary, this study aims to provide valuable insights into the effects of expiratory muscle training and trunk stabilization on sitting balance and quality of life in individuals with spinal cord injuries, focusing on those with neurological levels of T1 to T7. |