| CTRI Number |
CTRI/2023/11/059492 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Wheelchair Skill Training on Concern of Falling and Self-Confidence in Using a Wheelchair During Various Activities Among Individuals with Spinal Cord Injury Undergoing Rehabilitation |
|
Scientific Title of Study
|
Effect of Wheelchair Skill Training on Fall Concern and Perceived Self- Efficacy in Wheeled Mobility Among Individuals with Spinal Cord Injury Undergoing Rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Tokas |
| Designation |
PG student |
| Affiliation |
Indian Spinal Injuries Centre |
| Address |
Institute of Rehabilitation Sciences- Indian Spinal Injuries Centre,
Rehabilitation Department- ground floor
Sector C, Vasant Kunj, Opp. Vasant Valley School
South West
DELHI
110067
India |
| Phone |
9968844941 |
| Fax |
|
| Email |
tokasayushi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chitra Kataria |
| Designation |
Principal |
| Affiliation |
Indian Spinal Injury Centre- Institute of rehabilitation sciences |
| Address |
Indian Spinal Injuries Centre
Rehabilitation Department, ground floor
Sector C, Vasant Kunj, Opp. Vasant Valley School
South West
DELHI
110070
India |
| Phone |
9810310670 |
| Fax |
|
| Email |
chitrakataria@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chitra Kataria |
| Designation |
Principal |
| Affiliation |
Indian Spinal Injury Centre- Institute of rehabilitation sciences |
| Address |
Institute of Rehabilitation Sciences-Indian Spinal Injuries Centre
Rehabilitation department, ground floor
Sector C, Vasant Kunj, Opp. Vasant Valley School
South West
DELHI
110070
India |
| Phone |
9810310670 |
| Fax |
|
| Email |
chitrakataria@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of rehabilitation Sciences- Indian Spinal Injuries Centre |
|
|
Primary Sponsor
|
| Name |
Chitra Kataria |
| Address |
Indian Spinal Injuries Centre
Sector C, Vasant Kunj, Opp. Vasant Valley School |
| Type of Sponsor |
Other [Self] |
|
|
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 Chitra Kataria |
Indian Spinal Injuries Centre |
Rehabilitation Department
Ground floor
Sector C, Vasant Kunj, Opp. Vasant Valley School
South West
DELHI |
9810310670
chitrakataria@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Centre - Institutional Ethical Committee |
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 |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Wheelchair Skill Training |
A Total of 24hrs of training distributed over a period of 4 weeks- comprising of basic, community and advanced wheelchair skills. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Spinal Cord injury - paraplegics (AIS A to C, level of injury below T1) .
Medically Stable.
Not more than 1 year since injury, undergoing conventional rehabilitation.
Ability to maintain unsupported sitting position for 30 sec.
Using wheelchair as a primary mode of mobility.
Subjects who can read and understand English or Hindi.
|
|
| ExclusionCriteria |
| Details |
Subjects with diagnosed neurological/psychiatric problems that might impair learning.
Having upper limb pain/injury/ deformity limiting wheelchair mobility.
Subjects with unhealed pressure sores.
BMI > 30 , would hinder Wheelchair mobility.
Subjects with hearing/ visual impairment |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wheelchair Skills Test (WST) |
WST on day 0 and again after completion at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Spinal cord injury- fall concern scale ( SCI-FCS)
Self efficacy in wheeled mobility (SEWM) |
SCI FCS, SEWM on day 0 and again after completion at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2023 |
| Date of Study Completion (India) |
20/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The ability to perform safe and effective wheelchair skills, such as wheelies and propulsion up and down a ramp or curb, plays an important role in daily mobility of full-time manual wheelchair users with spinal cord injury (SCI). Majority of individuals do not self-propel their manual wheelchairs due to the lack of wheelchair skills training in India. Wheelchair skill training program(WSTP) is a formal standardized goal-setting & training method that can help individuals with spinal cord injury (SCI) understand the limits of their mobility skills in order to reduce the risks of tips & falls and regain control over their lives. The main goal of this study is to implement a safe, practical, and efficient wheelchair skills training protocol during the phase of rehabilitation after spinal cord injury and determine its efficacy on fall concern & confidence in a wheelchair. Patients will be selected based on inclusion and exclusion criteria. They will receive 16 sessions of wheelchair skill training over 4 weeks (4 sessions/week). The outcome measurements will be done by wheelchair skills test (WST), SCI fall concern scale (SCI FCS) and self-efficacy in wheeled mobility (SEWM. The changes in the pre and post outcome measure will help us to find out that if and how much is the wheelchair skill training programme effective in improving wheelchair skills, fall concern, confidence and functional ability in individuals with spinal cord injury undergoing supervised rehabilitation. |