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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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