| CTRI Number |
CTRI/2019/08/020841 [Registered on: 22/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Wheel-chair training on spinal cord injury patients. |
|
Scientific Title of Study
|
Effect of Wheel-chair training on Functional Capacity, Pulmonary Function and Quality of Life in individuals with Spinal cord injury. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayshree Parmar |
| Designation |
PhD Scholar, Lecturer |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Government Physiotherapy College, Government Spine Institute, Civil Hospital Campus, Asarwa.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879524994 |
| Fax |
|
| Email |
jayshreemsutaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali R Bhise |
| Designation |
I/c Principal, Senior Lecturer |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Government Physiotherapy College,Government Spine Institute,
Civil Hospital campus,Asarwa.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9427066624 |
| Fax |
|
| Email |
anjalibhise@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayshree Parmar |
| Designation |
PhD Scholar, Lecturer |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Government Physiotherapy College, Government Spine Institute, Civil Hospital Campus, Asarwa.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879524994 |
| Fax |
|
| Email |
jayshreemsutaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Spine Institute & Physiotherapy College,
Civil hospital campus, Asarwa, Ahmedabad-380016. |
|
|
Primary Sponsor
|
| Name |
Jayshree Parmar |
| Address |
Government Spine Institute & Physiotherapy college, Civil hospital campus, Asarwa, Ahmedabad-380016. |
| Type of Sponsor |
Other [Study for PhD thesis ] |
|
|
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 |
| Jayshree Parmar |
Government Spine Institute & Physiotherapy college |
Physiotherapy Department, Government Spine Institute & Physiotherapy college, Civil hospital campus, Asarwa, Ahmedabad-380016.
Ahmadabad
GUJARAT |
9879524994
jayshreemsutaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.J.Medical College & Civil Hospital Ahmedabad. |
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 Physiotherapy |
Control group will receive Conventional Physiotherapy 5 days a week for 6 weeks. |
| Intervention |
Wheel-chair training |
Intervention group will receive Wheel-chair training thrice a week on alternate days plus conventional physiotherapy 5 days a week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
Traumatic & non traumatic Spinal cord injury below T6 level
Complete & incomplete Spinal cord injury
ASIA scale A & B
Persons who are able to propel manual wheelchair |
|
| ExclusionCriteria |
| Details |
Any other neurological conditions
Any other orthopedic conditions
Fracture in upper limb & Cervical spine
Any Cardiac problems & respiratory conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 6 Minute Push Test |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 4 Functional Tasks |
6 Weeks |
| Pulmonary Function Test |
6 Weeks |
| Quality of life scale |
6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
26/08/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of present study is to examine the effect of manual wheel-chair training on functional capacity,pulmonary function and quality of life as intervention in spinal cord injury patients. |