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CTRI Number  CTRI/2024/02/062890 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Validity of Executive Function Performance test in Indian population with stroke 
Scientific Title of Study   Cross - Cultural Adaptation and Validation of Executive Function Performance Test in Indian Population With 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  Dolly Manchanda  
Designation  Student  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences, 2nd Floor, Near Faculty Room Vasant Kunj Rd, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  8810493550  
Fax    
Email  dollymanchanda5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priyanka Vijay 
Designation  Assistant Professor  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences, 2nd Floor, Faculty Room, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  9910631430  
Fax    
Email  priyanka_vijay02@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Priyanka Vijay 
Designation  Assistant Professor  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre Institute Of Rehabilitation Sciences, 2nd Floor, Faculty Room, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  9910631430  
Fax    
Email  priyanka_vijay02@yahoo.co.in  
 
Source of Monetary or Material Support  
INDIAN SPINAL INJURIES CENTER Sec-c, Vasant Kunj, New Delhi-110070,Groubd Floor Rehabilitation Department 
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre 
Address  Ground Floor, Rehabilitation Department, Indian Spinal Injuries Centre , Sector C , near Vasant Valley School , Vasant Kunj , New Delhi 
Type of Sponsor  Private hospital/clinic 
 
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 Priyanka Vijay  Indian Spinal Injuries Center  Rehablitation Department, Ground Floor, Vasant Kunj Rd, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi
New Delhi
DELHI 
9910631430

priyanka_vijay02@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries Centre Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  6 months post stroke
Ischemic or hemorrhagic stroke
Barthel Index score more than 90
Short blessed test score less than 12
 
 
ExclusionCriteria 
Details  Participants with prediagnosed neurological condition other than stroke
Participants with prediagnosed psychiatric condition
Participants with receptive aphasia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Barthel Index
Short Blessed Test  
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   29/02/2024 
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="5"
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  

Conventional neuropsychological tests collects information about particular aspects of cognition such as memory, attention or planning whereas Executive Function Performance Test takes a descriptive view of cognition where functional abilities are examined by making an individual perform a complete task. It serves three purposes: to determine which executive functions are impaired, to determine individual’s capacity for independent functioning, to determine the amount of assistance necessary for task completion.

Previous studies have reported that Executive Function Performance Test  is a reliable and valid assessment tool for occupational therapists to assess executive dysfunction in individuals with stroke. However, these studies were conducted primarily in western population whereas findings for this test in Indian population is still unclear. Cultural factors also influence performance on the EFPT , so a need was felt to cross- culturally validate this test. Therefore , the aim of the study is to Cross- culturally adapt and validate Executive Function Performance Test in Indian population with stroke.

In the study, we will be examining Content validity, Internal consistency reliability , Test- retest Reliability and Concurrent validity. The subjects will be recruited from Indian spinal injuries centre (ISIC) and community . Participants with 6 months post stroke (ischemic and hemorrhagic) ,age 18 and above ,both male and female , Barthel index >90, short blessed test <12  will be included in the study. Participants with prediagnosed neurological condition other than stroke, psychiatric conditions , receptive aphasia will be excluded.  

 
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