| CTRI Number |
CTRI/2024/07/071080 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation study |
| Study Design |
Other |
|
Public Title of Study
|
To find the relationship between heart fitness, independence in daily activities and wheelchair abilities in persons with spinal cord injury |
|
Scientific Title of Study
|
Correlation between Cardiovascular Fitness, Functional Independence and Wheelchair Skills 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 |
MANISHA S |
| Designation |
Student of Master of Physiotherapy (MPT) |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
PT33, Department of Physiotherapy, SRM College of Physiotherapy, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8610159951 |
| Fax |
|
| Email |
physiomanisha05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. M.Saravana Hari Ganesh |
| Designation |
Professor |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Room no PT05, 5th floor, Department of Physiotherapy, SRM College of Physiotherapy, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9789858104 |
| Fax |
|
| Email |
saravanm@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MANISHA S |
| Designation |
Student of Master of Physiotherapy (MPT) |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
PT33, Department of Physiotherapy, SRM College of Physiotherapy, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8610159951 |
| Fax |
|
| Email |
physiomanisha05@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpet, Kancheepuram, Tamil Nadu, India. Pin code-603203. |
|
|
Primary Sponsor
|
| Name |
MANISHA S |
| Address |
PT33, Department of Physiotherapy, SRM College of Physiotherapy, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India. |
| 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 |
| Prof M Saravana Hari Ganesh MPT |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Block J-2, Room No.7 Department of Physical Medicine and Rehabilitation, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu-603203
Kancheepuram
TAMIL NADU |
9789858104
saravanm@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G822||Paraplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Persons with either paraplegia or tetraplegia.
Person who uses manual wheelchair for their primary means of mobility
Person who independently propel a manual wheelchair with their upper extremities
Person who uses manual wheelchair for more than 6 months
Person should have ability to answer questions related to wheelchair use. |
|
| ExclusionCriteria |
| Details |
Persons who have recently changed/modified wheelchair during the test period
Resting HR greater than 120bpm
Systolic BP greater than 180mmHg
Diastolic BP greater than 100mmHg
Persons having cardiovascular conditions like angina or myocardial infarction
Persons not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Six minute push test |
During data collection
6MPT, SCIM, WST-Q taken at the same time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spinal Cord Independence Measure |
At the same time while collecting data for 6MPT, WST-Q |
| Wheelchair Skill Test Questionnaire |
At the same time while collecting data for 6MPT, SCIM |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
· Subjects will be selected based on the
inclusion and exclusion criteria and the purpose of the study will be clearly
explained to the subject.
·
From the subject informed consent will
be collected.
·
Demographic data with medical history
will be collected.
· Subject will be assessed for
cardiovascular fitness using 6-minute push test, functional independence using
Spinal Cord Independence Measure(SCIM-III) and wheelchair skills using WST-Q
(Wheelchair skill test Questionnaire).
·
6-minute push test will be
conducted. The distance a participant could propel as far as possible, on a
flat, hard surface, within 6 minutes. The distance between the two cones
(turning points) will be 10m. Marking tape will be placed at 1-m intervals.
Before starting, rest time for the participant is 10minutes in their
wheelchair. Standardized instructions will be used before and during testing.
The participants can slow down, stop, and rest during testing, if necessary,
but should resume propelling as soon as possible.
·
Spinal cord Independence Measure-III
(SCIM-III) assessment will be done.
·
WST-Questionnaire will be used
to assess capacity,
confidence and performance in using wheelchair. |