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CTRI Number  CTRI/2024/11/077399 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   QUALITATIVE 
Study Design  Other 
Public Title of Study   Exploring social participation among stroke survivors with residual upper limb deficits: a qualitative study. 
Scientific Title of Study   Exploring social participation among stroke survivors with persistent residual upper extremity dysfunction:a qualitative phenomenological 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  Chaitanya V Bhandarkar 
Designation  Post graduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD NO 5 neurophysiotherapy department SDM college of medical sciences and hospital Manjushreenagar Sattur Dharwad. Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  7259480181  
Fax    
Email  chaitanyabhandarkar26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chaitanya V Bhandarkar 
Designation  Post graduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD NO 5 Neurophysiotherapy department SDM college of medical sciences and hospital Manjushreenagar Sattur Dharwad. Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  7259480181  
Fax    
Email  chaitanyabhandarkar26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof. Sudhir Bhatbolan 
Designation  Professor 
Affiliation  SDM College of physiotherapy 
Address  OPD NO 5 Neurophysiotherapy department SDM college of medical sciences and hospital. Manjushreenagar Sattur Dharwad Karnataka 580009 India.

Dharwad
KARNATAKA
580009
India 
Phone  9886475757  
Fax    
Email  sudhirbhatbolan@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
SDM College of Physiotherapy Manjushreenagar, sattur Dharwad 580009 Karnataka India 
 
Primary Sponsor  
Name  Chaitanya V Bhandarkar 
Address  SDM college of physiotherapy Manjushreenagar Sattur Dharwad 580009 Karnataka India 
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 
Prof Sudhir Bhatbolan  SDM College Of Physiotherapy  OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad. 580009 Dharwad KARNATAKA
Dharwad
KARNATAKA 		 9886475757

sudhirbhatbolan@sdmuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G931||Anoxic brain damage, not elsewhereclassified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  • Individuals with 1st episode of stroke and of any gender who are willing to participate in the study.
• Patient having history of stroke greater than 1 year.
• Patients with visible upper extremity dysfunction.
• Patients who are able to comprehend and communicate verbally in either Kannada or English. 
 
ExclusionCriteria 
Details  • Individuals having history of any psychiatric illness.
• Patients who have completely recovered their upper extremity functions.
• Serious musculoskeletal conditions/disorders like fracture, dislocation affecting Upper limb activity.
• Stroke patients with severe cognitive, visual, perceptual and communication deficits.
• Individuals with coexisting neurological disorders like Parkinson’s disease, dementia, Alzheimer’s etc.
• Individuals who are bed bound. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SEMI-STRUCTURED INTERVIEW  One time assessment post 1 year of stroke diagnosis 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   15/12/2024 
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="1"
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   Stroke is a kind of medical emergency that can damage the brain, can lead to disability, and even death. Stroke is considered as 3rd leading cause of disability and 2nd major cause of death according to the global fact sheet 2022. In India, stroke is 4th leading cause of death and 5th leading cause of disability according to the National Stroke Registry programme conducted by ICMR and NCDIR. Post-stroke dysfunction in the upper limb, leading to loss of bimanual hand function, can alter a person’s life which hampers their ability to manage simple tasks of personal care leading to difficulty in performing ADL with precision such as dressing, cooking, washing dishes, bathing and toileting activities, etc. Upper limb Functional limitation results as a consequence of post-stroke impairments and a variety of factors influence the overall functional recovery including personal, clinical, Socio-demographic, and Genetic factors. It is noted that, in institutional rehabilitation centers, more focus will be implied on improving physical parameters along with the Basic Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL), and less focus is directed towards social activity and participation. Rehabilitation researchers should investigate whether and how ADL’S and IADL’S could be addressed and operationalized in standard upper limb assessment and therapy efforts. Few measures, however, account for upper limb-related difficulties with social participation, such as sustaining relationships, using transportation, engaging in employment, and leisure. Patients’ perspectives on what matters in their daily lives, which may differ greatly from clinicians’, are often ignored by these measures. The lack of tools and techniques in these areas may be part of the discrepancies between the objective and subjective perceptions of the effects of the physical catastrophe leading to upper extremity dysfunction. Scoping through available literature, there is limited data available pertaining to stroke survivors in the local demography which becomes amply vital considering the inconsistency in awareness, opportunities for a continuum of care, physical barriers, different belief systems, customs, and practices. Factoring the above aspects, understanding the patient’s perception about the impact of his condition on his life situations with respect to the varied dynamics within the community is essential to ensure better outcome post stroke. Qualitative methods are known to provide more insight and a deeper understanding of patients’ subjective perspective on community participation. A qualitative study in the form of a semi-structured interview can provide the meaning behind the scores of quantitative measures or help to better understand the scores. Most of the qualitative studies in social participation and community reintegration have been carried out in Western population and there is potential for further research in this area especially in the Indian context of stroke survivors as applicable to the regional demographic framework. Thus, a qualitative methodology that this utilizes aims to get a glimpse/understanding of the experiences of patients who are diagnosed with Stroke for the first time and are recovering in their respective communities post their acute care. Various domains like Knowledge and awareness of their condition, Activity, Recovery, Managing public settings, Role of health professional, Self-construction, and family/social roles are deemed important in the context of participation and this qualitative analysis to explore these aspects should provide an in-depth understanding of the patient’s perspective at the grass root level. The emphasis on the patient’s perspective is more valuable than trying to quantify these outcomes. 
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