| CTRI Number |
CTRI/2022/10/046851 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
25/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Experiences Regarding Return to Work Among Individuals With Stroke |
|
Scientific Title of Study
|
Experiences Regarding Return to Work Among Stroke Survivors: A Qualitative Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona Elsa Saji |
| Designation |
Student of Masters of Occupational Therapy in Neuro rehabilitation |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, 3rd floor Manipal College of
Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7338326278 |
| Fax |
|
| Email |
sona.saji@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guruprasad V |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, 3rd floor Manipal College of
Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9886215230 |
| Fax |
|
| Email |
guruprasad.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sona Elsa Saji |
| Designation |
Student of Masters of Occupational Therapy in Neuro rehabilitation |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, 3rd floor Manipal College of
Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7338326278 |
| Fax |
|
| Email |
sona.saji@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, MCHP, MAHE |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions Manipal |
| Address |
Department of Occupational Therapy, 3rd floor, Manipal College of
Health Professions, Manipal Academy of Higher Education, Manipal |
| 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 |
| Sona Elsa Saji |
Kasturba Medical College and Kasturba Hospital, Manipal |
N1,First floor, Department of Occupational Therapy, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7338326278
sona.saji@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,- [ ] Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Males and females between 18- 60 years old
Individuals who had paid employment till the onset of stroke
Individuals who had returned to work after a stroke
Minimum three months post-stroke
Adequate communication skills to speak in either Kannada or Malayalam or English
Fugl-Meyer score>84
MoCA score > 26
|
|
| ExclusionCriteria |
| Details |
Participants who have any other diagnosed psychiatric illness like schizophrenia, depression etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the experiences of stroke survivors regarding return to work. |
The data analysis will be done at one time point after the interviews as it is a one time observational qualitative study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
28/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is one of the major causes of mortality and disability and therefore a global public health issue, with far-reaching implications for a person’s ability to function in society. The incidence and prevalence of stroke are high in India and return to work (RTW) after stroke is considered an important goal for stroke survivors. The literature reveals that communication and collaboration among stroke survivors, occupational therapists, stakeholders and other rehabilitation professionals is crucial in helping stroke survivors maintain their jobs after stroke. A qualitative study that focuses on the experiences of stroke survivors need to be conducted to examine more deeply the complex and multifactorial process of RTW after stroke.
There is a need to understand stroke survivors’ experiences with the RTW process.
Available studies are mostly from Western countries, which might have limited generalization in the Indian context because of the differences in social, political & cultural framework and the healthcare infrastructure.
Hence, there is a need to explore the experiences of individuals in RTW following stroke in the Indian context. |