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CTRI Number  CTRI/2024/08/072763 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 18/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Scale Translation Study]  
Study Design  Other 
Public Title of Study   Translation , Reliability and Validity of Beck Depression Inventory-II in Gujarati version in people with acute stroke 
Scientific Title of Study   Cross- Cultural Adaptation, Reliability and validity of Gujarati Version of the Beck Depression Inventory- II in people with acute stroke  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishvi Patel  
Designation  MPT Scholar 
Affiliation  parul institute of physiotherapy 
Address  room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat

Vadodara
GUJARAT
391760
India 
Phone  6351385868  
Fax    
Email  aishvi56@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrChaitali Shah 
Designation  Associate professor  
Affiliation  parul institute of physiotherapy 
Address  room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat

Vadodara
GUJARAT
391760
India 
Phone  9998107262  
Fax    
Email  chaitalishah@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  DrChaitali Shah 
Designation  Associate professor  
Affiliation  parul institute of physiotherapy 
Address  room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat


GUJARAT
391760
India 
Phone  9998107262  
Fax    
Email  chaitalishah@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
room no. 309 3rd floor Parul Institute of Physiotherapy, parul university post. Limda waghodia vadodara gujarat Vadodara GUJARAT 391760 India 
 
Primary Sponsor  
Name  Aishvi Patel 
Address  room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat, India pincode 391760 
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 
DrAishvi Patel  Parul Sevashram Hospital  room no. 232 neuro opd, 2nd floor, parul sevashram hospital , parul university, post limda, waghodia, gujarat, India
Vadodara
GUJARAT 
6351385868

aishvi56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul university institutional ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Beck Depression Inventory-II  The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13.Over the course of a month, it poses questions regarding low mood, feelings The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13.Over the course of a month, it poses questions regarding low mood, feelings of helplessness, psychomotor retardation, guilt and restlessness, and depression. (7) There have been two significant updates to the BDI: the BDI-I in 1978 and the BDI-II in 1996. The improved BDI-II measures physical and psychological symptoms of major depression episodes lasting two weeks. 
Comparator Agent  Reliability and Validity of the Gujarati Version of the Beck Depression Inventory-II  Beck Depression Inventory-II will be translated into Gujarati Version and then Reliability and Validity of the scale will be calculated  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants who are ready to give consent. Participants diagnosed with ischemic or hemorrhagic stroke by physician or neurophysician.
Both male and females.
Able to understand Gujarati language.
Able to follow commands. 
 
ExclusionCriteria 
Details  Any cognitive or perceptual disorders.
Any visuospatial impairment
Patient severe consciousness problem
Has referred psychiatrist and undergoing treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Beck Depression Inventory-II  1 day/week 
 
Secondary Outcome  
Outcome  TimePoints 
Geriatric Depression scale-15  1 day/ week 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   05/09/2024 
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="6"
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  
Depression is one of the most common neuropsychiatric disorders in stroke patients. Post stroke depression (PSD) is a well-known phenomenon and It occurs in at least a quarter of stroke survivors in the first year after the stroke. About one in three stroke survivors suffered from depression after the stroke. Post stroke depression nearly affects 85% of the strokes and is linked to more severe functional dysfunction, poor rehabilitation outcomes, and social isolation after stroke
Depressed mood apathy, weight loss or increase, sleep disturbances, exhaustion, worthlessness, and anhedonia are the primary clinical signs of post stroke depression. This greatly affected functional rehabilitation, causing a poor quality of life. The Beck Depression Inventory (BDI), developed by Dr. Aaron T. Beck in 1961, consists of 21 multiple-choice questions for self-report. It is a 21-item measure designed to evaluate depression in both adults and adolescents over the age of 13. Over the course of a month, it poses questions regarding low mood, feelings of helplessness, psychomotor retardation, guilt and restlessness, and depression.There have been two significant updates to the BDI: the BDI-I in 1978 and the BDI-II in 1996. The improved BDI-II measures physical and psychological symptoms of major depression episodes lasting two weeks. Some components have been replaced in this version. Agitation, worthlessness, difficulty concentrating, and energy loss were substituted for four BDI-I items that proved less sensitive for identifying typical symptoms of severe depression: weight loss, distorted body image, somatic preoccupation, and inability to work.The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. In those diagnosed with depression, scores of 0–13 indicate minimal depression, 14–19 (mild depression), 20–28 (moderate depression) and 29–63 (severe depression)
The scores above 20 indicate depression.
 
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