| CTRI Number |
CTRI/2025/08/093194 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| 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 Lung Health and Life Quality in People with Spinal Cord Injury using Wheelchair Skills Training Program |
|
Scientific Title of Study
|
To evaluate the effect of wheelchair skills training program in enhancing pulmonary function and quality of life in persons 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 |
Aarti Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy department, E-block, College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9034416438 |
| Fax |
|
| Email |
aartisharmaa738@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy department, Faculty room, E-block, College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
09992822644 |
| Fax |
|
| Email |
bhawna_pt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy department, E-block, College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
09034416438 |
| Fax |
|
| Email |
aartisharmaa738@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana-124001 |
|
|
Primary Sponsor
|
| Name |
Pt B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| Address |
College of Physiotherapy, Pt B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Aarti Sharma |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Department of Paraplegia, PGIMS
Rohtak
HARYANA |
9034416438
aartisharmaa738@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional cardiopulmonary physiotherapy and normal wheelchair maneuvering |
Conventional cardiopulmonary physiotherapy will include Diaphragm (Abdominal) breathing exercise, Pursed lip breathing exercise, Segmental breathing exercise, Inspiratory muscle strengthening exercise. These will be given for 1 hour session for 2 days a week for 4 weeks.Total duration will be 8 hours in 4 weeks. |
| Intervention |
Wheelchair skills training program and conventional cardiopulmonary physiotherapy |
It will be given for 1 hour session for 2 days a week for 4 weeks.Total duration of intervention will be 8 hours in 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Minimum post-injury duration of 6 months.
2.Ability to sit independently.
3.Diagnosed as a thoracic spinal cord injury (T-SCI) and categorized B/C according to ASIA classification system. |
|
| ExclusionCriteria |
| Details |
1.Presence of pressure sores.
2.Neurological condition other than SCI such as stroke, traumatic brain injury and degenerative brain disease.
3.Medical history affecting pulmonary function such as COPD, bronchial asthma.
4.Body mass index 30 or greater.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test(PFT)
12 minute wheelchair aerobic test (12 MWAT)
Modified Borg Scale (MBS)
WHOQOL-BREFQuestionnaire
|
Baseline, after 4 weeks, after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spinal cord independence measure-IV(SCIM-IV) |
Baseline, after 4 weeks, after 2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/08/2025 |
| 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 Applicable |
| 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
|
Background: Spinal cord injury (SCI) often leads to respiratory muscle weakness, reduced lung volumes, and impaired functional abilities. Pulmonary complications are a leading cause of morbidity and mortality in this population. Wheelchair skills training programs (WSTP) and cardiopulmonary exercise interventions may help improve pulmonary function, dyspnoea levels, mobility, and quality of life. Objectives: To evaluate and compare the effects of WSTP combined with cardiopulmonary exercise intervention versus conventional physiotherapy with wheelchair manoeuvring on pulmonary function, dyspnoea, functional abilities, and quality of life in individuals with thoracic SCI. Methods: A total of 40 participants diagnosed with thoracic SCI (ASIA B/C) will be randomly allocated into two groups: Group A (n=20): (Experimental group) Conventional cardiopulmonary physiotherapy + WSTP. Group B (n=20): (Control group) Conventional chest physiotherapy + wheelchair manoeuvring. Outcome measures: Pulmonary Function Test (PFT), 12 Minute Wheelchair Aerobic Test (12MWAT), Modified Borg Scale (MBS), Spinal Cord Independence Measure-IV (SCIM-IV), and WHOQOL-BREF Questionnaire. Data will be analysed using SPSS. Result: Results will indicate the effects of the two interventions on pulmonary function, dyspnoea levels, functional abilities, and quality of life in individuals with thoracic SCI. Conclusion: The study will provide evidence on the role of WSTP combined with cardiopulmonary exercise in improving respiratory and functional outcomes in persons with thoracic SCI, potentially guiding rehabilitation practices. |