| CTRI Number |
CTRI/2025/11/097327 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Balance and Confidence in People with Spinal Cord Injury Through Wheelchair Skills Training |
|
Scientific Title of Study
|
To evaluate the effect of wheelchair skills training programme in enhancing
sitting balance, functionality and confidence 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 |
Subham |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences |
| Address |
Physiotherapy department, College of Physiotherapy, E-block,
PGIMS Rohtak HARYANA 124001 India
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9991462059 |
| Fax |
|
| Email |
bhattisubham88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences |
| Address |
Physiotherapy Department, Faculty room , E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992822644 |
| Fax |
|
| Email |
Bhawna_pt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences |
| Address |
Physiotherapy Department, Faculty room , E-Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992822644 |
| Fax |
|
| Email |
Bhawna_pt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 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 Subham PT |
Paraplegia department of Pt. B.D. Sharma, PGIMS, Rohtak |
Room no. - 3, Department of Paraplegia , E - block College of Physiotherapy , Pt. B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA |
9991462059
bhattisubham88@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: S320||Fracture of lumbar vertebra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A ( WST) |
Group A (WST group) Wheelchair skills are a set of manoeuvres includes in wheelchair
skills training program including turning, managing obstacles, ramps & different terrains.
After the training the participants will be evaluated using Wheelchair Skills Test
12
Questionnaire. |
| Comparator Agent |
Group B (control group) |
Control group will undergo strengthening &
balance exercise and will be taught normal wheelchair manoeuvring. It includes
fundamental actions of pushing forward, hiking and stopping in a flat accessible
environment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-50 years.1
2. Minimum post-injury duration
6 months.10
3. Able to sit independently.1
4. Diagnosed as having a thoracic
SCI and categorised as B/C acc.
to American spinal injury
association impairment scale |
|
| ExclusionCriteria |
| Details |
Presence of pressure sores.13
2. Neurological or unstable condition
other than SCI.14
3. Heart condition that could
exacerbate by physical activity.15 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Activity based balance level evaluation scale
2.World Health Organization Quality of life BREF
3.Spinal cord independence measure IV
4.Wheelchair outcomes measure
5.Wheelchair use confidence scale |
11.Baseline or initial assessment
2.After 8 sessions or after intervention
3. After 2 months followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Activity based balance level evaluation scale
2.World Health Organization Quality of life BREF
3.Spinal cord independence measure IV
4.Wheelchair outcomes measure
5.Wheelchair use confidence scale |
1.Baseline or initial assessment
2.After 8 sessions or after intervention
3. After 2 months followup |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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="0"
Months="11"
Days="30" |
|
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
|
In this study ,To evaluate the effect of wheelchair skills training programme in enhancing sitting balance,functionality and confidence in persons with spinal cord injury. In this study we will recruit 40 patients of SCI and divide them in two groups , groupA(WST Group )(n=20) they will undergo wheelchair skills training program and in groupB (control group)patients will get strengthening & balance exercise and will be taught normal wheelchair manoeuvring for 8 sessions 2 sessions per week . |