| CTRI Number |
CTRI/2021/08/036077 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
05/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study relation of emotional intelligence and Health related quality of life in people with stroke of duration more than 6 months and who have left side weakness |
|
Scientific Title of Study
|
The relationship between emotional intelligence and Health related qaulity of life in chronic stroke subects (left hemiplegia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Chetan Badani |
| Designation |
Post Graduate student of Physiotherapy |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi,Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9920025609 |
| Fax |
|
| Email |
badaniprachi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Wasnik |
| Designation |
HOD, Lecturer,Physiotherapy |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi,Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Wasnik |
| Designation |
HOD, Lecturer,Physiotherapy |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi,Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, All India Institute Of Physical Medicine and Rehabilitation, Mumbai |
|
|
Primary Sponsor
|
| Name |
Prachi Chetan Badani |
| Address |
Department Of Physiotherapy, All India Insitute of Physical Medicine and Rehabilitation, Mahalaxmi , Mumbai |
| 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 |
| Prachi Chetan Badani |
All India Institute of Physical Medicine and Rehabilitation |
Room no. 207, Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation,Mahalaxmi
Mumbai
MAHARASHTRA |
9920025609
badaniprachi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with stroke
1)Between the age group of 20-60 years
2)Duration of stroke more than 6 months
3)Individuals with left hemiplegia only
4)Non-aphasic
5)Individuals who can read and understand Hindi adapted version of Trait Emotional Intelligence questionnaire- short form
6)Brunnstorm recovery grade -4,5,6
7)Montreal Cognitive Assessment score either 18 or greater than 18
8)Individuals with Spo2 level more than 92
|
|
| ExclusionCriteria |
| Details |
1)Moderate or severe cognitive impairment on Montreal cognitive assessment (score below 18)
2)Unilateral neglect
3)Individuals who are left dominant pre-stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Hindi adapted version of Trait Emotional Intelligence questionnaire - short form
2)Stroke Impact Scale |
one time assessment - baseline only ( cross sectional observational study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
03/09/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional observational study assessing the relation between Emotional intelligence and Health-related quality of life in chronic stroke subjects (left hemiplegia). A total of 25 participants will be recruited for the study using the convenience sampling method. The outcome measure used will be a Hindi adapted version of Trait emotional intelligence questionnaire - short form for measuring emotional intelligence. Health-related quality of life will be assessed using the Stroke Impact Scale. After the data is collected it will be statistically analyzed to understand the relation. |