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CTRI Number  CTRI/2024/06/068325 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Does caregiving to stroke patients cause stress among caretakers 
Scientific Title of Study   A study to analyze the stress among caregivers of acute stroke patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavithra K 
Designation  MPT Neurosciences 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar Chennai TAMIL NADU 600116

Chennai
TAMIL NADU
600116
India 
Phone  8939043012  
Fax    
Email  pavithra22sai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Radhika C M 
Designation  MPT Neurosciences 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar, Chennai ,Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Radhika C M 
Designation  MPT Neurosciences 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar, Chennai ,Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Pavithra K 
Address  2nd floor, Room no- 2.7, Sri Ramachandra Faculty Of Physiotherapy, Sri Ramachandra Institute Of Higher Education and Research, Ramachandra nagar, Porur, Chennai- 600 116 
Type of Sponsor  Other [Self funding] 
 
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 Pavithra K  Sri Ramachandra Hospital - In patient   G block, 1st floor, Sri Ramachandra Medical college, Sri Ramachandra Nagar, Porur,Chennai- 600116
Chennai
TAMIL NADU 
8939043012

pavithra22sai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of acute stroke patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with stroke, Comprehending and requiring ADL assistance from their caregivers, MODIFIED RANKIN SCALE score 3-5 .
2.For caregivers: Known Language of caregivers - English and Tamil
Care giver being a family member -father, mother, sister, spouse and above 18 years of age
Caregiver providing care for a stroke patient for at least 6 hours a day
Minimum level of literacy among caregivers.  
 
ExclusionCriteria 
Details  i)Unwillingness to participate
ii)Severe cognitive impairment
iii)Recurrent stroke 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Modified Rankin Scale (MRS)  On the day of the assessment of patients
 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Caregivers Strain Index   From the day of discharge to post 10 days of discharge 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   17/06/2024 
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="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  
In India the prevalence of stroke is estimated about 1.8% and 40% of the stroke population continue physical therapy services. The major factors which may influence them to continue rehabilitation includes their economic status, gender, age, residence, need for assistance in their day to day activities. (Bharati B et al.,2021) Moreover these post-stroke patients experience long-term difficulties in terms of physical or functional impairments that leads to disability hence community reintegration and emotional functioning becomes very difficult for these patients. (Norrving B et al.,2018). Due to continuous disability, stroke survivors usually require long-term assistance from their caregivers. The majority of the stroke survivors are taken care by their family members. Furthermore, it was also found that caregivers devote a median of 35 hours per week to care for the patient during initial 12 months following stroke which may be harmful to the caregiver’s health and well-being like their psychological health (eg. stress), thus care giving is linked to higher levels of stress, poor quality of life, physical weariness, anxiety, which may have an impact on care giving Due to its debilitating and chronic nature of the disease, caring for stroke patients often puts a considerable stress on their caregiver’s leading to caregiver strain and significant stress, unfortunately these components have been neglected in stroke patient care . Even though there are evidence to suggest that caregiver stress may have a major impact on the recovery and successful rehabilitation of stroke patients .(Bhavin Manowara et al.,2020). These care givers face several challenges while taking care of stroke patients. No study has been done to identify the individual factors that leads to stress for care givers especially among stroke patients where the need and care of the patients becomes entirely different. Thus we intended to do a study to identify and measure the specific causes for the stress on caregivers during stroke rehabilitation.
 
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