| CTRI Number |
CTRI/2024/09/074056 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Patterns of occupations among individuals with stroke |
|
Scientific Title of Study
|
Experiences related to patterns of occupations among individuals with stroke in Udupi district: A Qualitative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Swena Sandeep Jadhav |
| Designation |
Postgraduate Student |
| Affiliation |
|
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Eductaion, Manipal, Udupi Karnataka, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
9689739479 |
| Fax |
|
| Email |
swenajadhav@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Shashank Mehrotra |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Eductaion, Manipal, Udupi Karnataka, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
09743490209 |
| Fax |
|
| Email |
shashank.mehrotra@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Mr Shashank Mehrotra |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Eductaion, Manipal, Udupi Karnataka, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
09743490209 |
| Fax |
|
| Email |
shashank.mehrotra@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions |
|
|
Primary Sponsor
|
| Name |
Miss. Swena Sandeep Jadhav |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Eductaion, Manipal, Udupi Karnataka, India- 576104 |
| 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 |
| Dr Shashank Mehrotra |
Kasturba Hospital |
Department of Occupational Therapy/Baliga Block/N1-Ground floor
Department of Community Medicine/Rural Maternity and Child Welfare Homes/Rehabilitation room-PHCs Aleevoor, Udyavara, Kadekar Udupi KARNATAKA |
9743490209
shashank.mehrotra@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
(1) Individuals (both male and female) with a clinical diagnosis of stroke as confirmed by previous medical records, minimum of 1 year post stroke.(2) English and/or Hindi speaking individuals who have provided informed consent and can read and write in the language will be included in the study. |
|
| ExclusionCriteria |
| Details |
(1) Individuals with stroke residing in institutionalized settings. (2)Individuals diagnosed with Transient Ischemic Attack, Neuromusculoskeletal conditions, Congenital disabilities, Psychiatric illnesses, Intellectual disabilities and/or aphasia (3)Participants with cognitive and communication difficulties hampering their ability to participate in the research. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand experiences specific to the roles, routines, habits and rituals in individuals with stroke.
To understand strategies, they may have used to cope up with/ to adapt to change in the roles, routines, habits and rituals.
|
Baseline |
|
|
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)
|
15/10/2024 |
| 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="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a qualitative study with a phenomenological approach. 12 individuals with stroke will be recruited through purposive sampling. Participants will be identified from the district of Udupi, who sought intervention from the Department of Occupational Therapy, Kasturba Hospital, and those receiving services from the Rural Maternity and Child Welfare homes, (under the field practice area of department of community medicine) from the areas of Alevoor, Kadekar and Udyavar. (1) Individuals (both male and female) with a clinical diagnosis of stroke as confirmed by previous medical records, minimum of 1 year post stroke.(2) English and/or Hindi speaking individuals who have provided informed consent and can read and write in the language will be included in the study. Participants will be excluded based on the following criteria:(1) Individuals with stroke residing in institutionalized settings. (2)Individuals diagnosed with Transient Ischemic Attack, Neuromusculoskeletal conditions, Congenital disabilities, Psychiatric illnesses, Intellectual disabilities and/or aphasia (3)Participants with cognitive and communication difficulties hampering their ability to participate in the research. Interviews will use data collected through a time-diary and a semi-structured guide to facilitate the discussion of their experiences related to their patterns of occupations especially their roles, routines, rituals and habits. |