| CTRI Number |
CTRI/2025/02/080602 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating Adult Executive Function Inventory (ADEXI) in Malayalam |
|
Scientific Title of Study
|
Validation of Malayalam version of Adult Executive Function Inventory (ADEXI) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Linda Jacob |
| Designation |
PG Scholar |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Medical Trust Institute of Medical Sciences
HOC Township, Makaliyam Kavaraparambu Rd
BMC Nagar Colony
Irumpanam,Kochi
Ernakulam
KERALA
682309
India |
| Phone |
8078751169 |
| Fax |
|
| Email |
lindatreesa21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jacob Mathew |
| Designation |
Assistant Proffesor |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Medical Trust Institute of Medical Sciences
HOC Township, Makaliyam Kavaraparambu Rd
BMC Nagar Colony
Irumpanam,Kochi
Ernakulam
KERALA
682309
India |
| Phone |
8281319964 |
| Fax |
|
| Email |
jacobmathewphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof . Anila Paul |
| Designation |
Proffessor |
| Affiliation |
Kerala University of Health Sciences |
| Address |
HOC Township,Makaliyam Kavaraparambu Rd
BMC Nagar Colony
Irumpanam, Kochi
Ernakulam
KERALA
682309
India |
| Phone |
08547992248 |
| Fax |
|
| Email |
mtimsbpt@medicaltrusthospital.in |
|
|
Source of Monetary or Material Support
|
| Medical Trust Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Medical Trust Institute of Medical Sciences |
| Address |
HOC Township, Makaliyam
Kavaraparambu Road,
BMC Nagar Colony, Irumpanam, Kochi,Ernakulam, Kerala
Pin :682309 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Prof Anila Paul |
Medical Trust Institute of Medical Sciences |
HOC Township,Makaliyam Kavaraparambu Rd,BMC Nagar Colony, Irumpanam,Near, Kochi, Ernakulam, 682309
Ernakulam
KERALA |
8547992248
mtimsbpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z00.00 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects aged between 18 & 60 years
2 Subjects who are literate in both English and Malayalam
3 Subjects who are able to provide informed consent to participate in the study
4 Subjects who do not have a history of neurodevelopmental disorders (that is, autism spectrum disorders, ADHD, intellectual disability and mental retardation or disruptive, impulse-control, and conduct disorders) or specific learning disorder
|
|
| ExclusionCriteria |
| Details |
1 People who are Illiterate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Interpersonal Reactivity Index (IRI)
(2) Cognitive Flexibility scale (CFS)
(3) The Buss Perry Aggression Questionnaire |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
20/02/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
According
to the current evidence, subjective measures are more preferable in order to
check executive function because of their ecological validity. The briefness of
ADEXI is an additional asset in the clinical field because it helps subjects
with executive dysfunction who may have difficulty completing longer
instruments. Due to language barriers,
there is a necessity to translate ADEXI into Malayalam to check executive
function among Keralites. So, the present study will be conducted to translate
the ADEXI self-report version into Malayalam and then to find the reliability
and validity of the same. |