| CTRI Number |
CTRI/2025/06/089008 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study on user’s feedback to an innovative multifunctional mobility assistive wheelchair |
|
Scientific Title of Study
|
An observational study on user’s feedback to an innovative multifunctional mobility assistive wheelchair |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddharth Rai |
| Designation |
Associate professor |
| Affiliation |
SGPGIMS |
| Address |
Dept of Physical Medicine and Rehabilitation
Apex trauma center, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9650690822 |
| Fax |
|
| Email |
Siddharth.bmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Rai |
| Designation |
Associate professor |
| Affiliation |
SGPGIMS |
| Address |
Dept of Physical Medicine and Rehabilitation
Apex trauma center, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9650690822 |
| Fax |
|
| Email |
Siddharth.bmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth Rai |
| Designation |
Associate professor |
| Affiliation |
SGPGIMS |
| Address |
Dept of Physical Medicine and Rehabilitation
Apex trauma center, SGPGIMS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9650690822 |
| Fax |
|
| Email |
Siddharth.bmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareilly Road, Lucknow 226014 India |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of medical sciences |
| Address |
Raebareilly road Lucknow India 226014 |
| 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 Siddharth Rai |
Apex Trauma Center SGPGIMS |
Raebareilly road, Vrindavan Yojana Lucknow
Lucknow
UTTAR PRADESH |
9650690822
Siddharth.bmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Spinal cord injury patients
Inclusion Criteria: Participants must meet the following criteria to be included in the study
Age: 18 years and older
Diagnosed with spinal cord injury
Limited mobility as assessed by a Physiatrist.
Willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they meet any of the following criteria:
Severe cognitive impairment that may impact the ability to use the assistive device safely.
Uncontrolled medical conditions that may pose a risk during the study.
Known allergies to materials used in the assistive device.
Pregnancy, as the effects of the device on pregnant individuals have not been studied.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| satisfaction score for the usability of this innovative wheelchair |
0 and 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Improving participation in various activities of life is a central goal of rehabilitation among people with spinal cord injury (SCI). It is observed that wheel chair users reported positive changes in daily activities and improved participation. Clinically, it is important to carefully document the perceived impact of wheelchair on the user’s daily life. There is lack of information regarding the impact of wheelchair on participation and satisfaction level in wheel chair users with SCI. This study is being done to find out the association between assistive device user perceived satisfaction and participation and community integration in people with chronic SCI. The study results may be critical in identifying the extent of association of user satisfaction with participation and community integration in wheelchair bound people with SCI. After using the wheel chair for minimum 4 hours a day for at least 2 weeks, patient, their care givers and medical staff will be given a pre designed and pre tested questionnaire to assess their feedback for the usability of this innovative wheelchair. The questionnaire has 12 items and each item is scored on a 5 point scale [ranging from not satisfied at all (0) to very satisfied (5). Items in the satisfaction with the device domain include dimensions, weight, adjustments, safety, durability, simplicity of use, comfort and effectiveness. The total score was calculated by adding the ratings of the valid responses and divided this sum by number of valid items. The same procedure is followed for device subscale and services subscale scoring.
|