| CTRI Number |
CTRI/2024/04/065570 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing 3 types of wheelchairs for female wheelchair users for their everyday activities |
|
Scientific Title of Study
|
Comparing the benefits of a customisable manual wheelchair, power-assist for
wheelchairs and a standard manual wheel chair on everyday activities of female wheelchair users – A Randomised Controlled Trial |
| 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 Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
TTK Center for Rehabilitation Research and Device Development, IIT Madras |
| Address |
Department of Mechanical Engineering Indian Institute of Technology, Madras
Chennai
TAMIL NADU
600036
India |
| Phone |
04422575695 |
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
TTK Center for Rehabilitation Research and Device Development, IIT Madras |
| Address |
Department of Mechanical Engineering Indian Institute of Technology, Madras
Chennai
TAMIL NADU
600036
India |
| Phone |
04422575695 |
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
TTK Center for Rehabilitation Research and Device Development, IIT Madras |
| Address |
Department of Mechanical Engineering Indian Institute of Technology, Madras
Chennai
TAMIL NADU
600036
India |
| Phone |
04422575695 |
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
|
Source of Monetary or Material Support
|
| TTK Center for
Rehabilitation Research and Device Development |
|
|
Primary Sponsor
|
| Name |
TTK Center for Rehabilitation Research and Device Development |
| Address |
311, Second Floor, Machine Design Section Indian Institute of Technology Madras Chennai 600036 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Mr Sunil Raj PT |
Chandigarh Spinal Rehab |
Plot #1, Madhya Marg, Sector 28A, Sector 28, Chandigarh, 160002
Chandigarh
CHANDIGARH |
9489293077
sunilrajphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - INDIAN INSTITUTE OF TECHNOLOGY MADRAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (2) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (3) ICD-10 Condition: I639||Cerebral infarction, unspecified, (4) ICD-10 Condition: Z895||Acquired absence of leg below knee, (5) ICD-10 Condition: Z896||Acquired absence of leg above knee, (6) ICD-10 Condition: G14||Postpolio syndrome, (7) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customised Manual Wheelchair |
The participants, who already have their own wheelchair will be asked to use a customised manual wheelchair provided to them for 1 month |
| Intervention |
Customised manual wheelchair with a power assist |
The participants, who already have their own wheelchair will be asked to use a customised manual wheelchair with a power assist provided to them for 1 month |
| Comparator Agent |
Standard Manual Wheelchair |
The participants will be asked to continue using their existing standard manual wheelchair |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female participants with
spinal cord injury (complete and
incomplete) between C5 - T12 level,
lower-limb amputation who use
wheelchairs,
Stroke - Paraparesis presentation
Post Polio Residual Syndrome
Cerebral Palsy
2. Participants living within 30kms of trained wheelchair prescription
professionals
3. Experienced wheelchair users with at least 6 months of usage
4. Weight - 35 to 110 kg
5. Height - 145 to 180 cm
6. Hip width - 33 cm to 16 cm
7. Sitting balance - Fair
8. Range of Motion - At least 90 degrees of hip and knee flexion. Up to
5 degrees of ankle plantarflexion.
9. Complete, active range of motion of shoulder, elbow and wrist joints
10. Hand function – Fair |
|
| ExclusionCriteria |
| Details |
1. Skin injuries - Grade 2, 3 or 4 over the sacrum, ischium, greater trochanter, lesser trochanter, coccyx, calcaneum, popliteal fossa, olecranon process and anywhere in the entire posterior surface of thigh, from ischial tuberosity to popliteal fossa
2. Involuntary movements in lower limbs and trunk strong enough to disturb
sitting balance.
3. Spasticity in any muscle group of upper and lower limb greater than grade
3 on Modified Ashworth Scale
4. Fixed Pelvic obliquity
5. Fixed Scoliosis
6. Fixed Kyphosis
7. Postural Hypotension
8. Unhealed musculoskeletal injuries or deformities such as unhealed
fractures, heterotopic ossification, myositis ossificans
9. Affected higher mental functions
10. Hemiplegia or Hemiparesis |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reintegration to Normal Living Index (RNLI) |
Will be administered at baseline (Week 0) and post-intervention (Week 5) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self-Reported Questionnaire |
Will be administered at baseline (Week 0) and post-intervention (Week 5) |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
22/04/2024 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sujsree@iitm.ac.in].
- For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study on female wheelchair users will provide 2 types of wheelchairs to 2 groups of participants - A customised manual wheelchair and a power assisted wheelchair respectively. The effect of these 2 wheelchairs on daily activities will be compared to participants using a standard manual wheelchair. The data will be analysed to assess the impact of the 3 different wheelchairs on productivity and leisure of female wheelchair users. |