| 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
|
|
|
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
|
|
|
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. |