| CTRI Number |
CTRI/2025/08/093073 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed-Method Approach |
| Study Design |
Other |
|
Public Title of Study
|
Development and Validation of Executive Function Scale for Basketball Players |
|
Scientific Title of Study
|
Comprehensive Executive Function Index Scale: Development, Validation and Reliability Testing for Basketball Players |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Raghuwanshi |
| Designation |
PhD Scholar (Physiotherapy) |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
Room No: SHS 231, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kalyanpur, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8299784274 |
| Fax |
|
| Email |
anjaliraghuwanshi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adarsh Kumar Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
Room Number 144, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur
Organization: Chhatrapati Shahu Ji Maharaj University
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8299784274 |
| Fax |
|
| Email |
adarshsrivastava13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Raghuwanshi |
| Designation |
PhD Scholar (Physiotherapy) |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
Room No:SHS 231, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8299784274 |
| Fax |
|
| Email |
anjaliraghuwanshi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kalyanpur, Kanpur, 208024, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
No |
| Address |
No |
| Type of Sponsor |
Other [Self] |
|
|
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 Anjali Raghuwanshi |
Chhatrapati Shahu Ji Maharaj University |
Room Number: SHS 231, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH |
8299784274
anjaliraghuwanshi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, Chhatrapati Shahu Ji Maharaj University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Basketball Players and Coaches |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Basketball Players and Coaches (BPC) with a minimum of 3 years of experience
2. BPC who can understand simple commands
3. BPC who can read and understand English
4. BPC Willing to participate
|
|
| ExclusionCriteria |
| Details |
1. BPC with any medical condition or comorbidities that may limit their participation in the game
2. Inexperienced or amateur BPC |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive Execution Function Scale (CEFIS) |
Twice a week |
|
|
Secondary Outcome
|
|
|
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)
|
25/08/2025 |
| 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)
|
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
|
Background: Inhibition, working memory (WM), and cognitive flexibility (CF) are the key domains of the executive function (EF) that enable basketball players (BP) to anticipate opponents’ actions and strategies and adjust quickly as the game changes. Some scales evaluate the independent component in individuals. To date, no scale is available to measure the combined inhibition, WM, and CF in basketball players. Objectives: The study aims to develop a combined measure of inhibition, WM, and CF, as a comprehensive executive function index scale (CEFIS) and to validate the scale for its content, reliability, and minimum detectable change (MDC). Methods: The study involves three stages. The first stage is scale (CEFIS) item development and validation. This includes domain and the item generated through a systematic literature search to extract items related to inhibition, WM, and CF in BP and through structured interviews. The expert group will then review the created domains and all items before being revised and tested in a pilot approach. Based on the responsiveness of pilot testing, it will be finally revised. The second stage is to validate the scale for its content. This stage is to assess the test re-test reliability and inter-rater reliability. The third stage is the final stage in which the study determines the standard error of measurement (SEM) and the minimal detectable change (MDC) at the generated scale’s 95% confidence interval (CI). Discussion: CEFIS will be the first among the scales to measure the combined Inhibition, working memory (WM), and cognitive flexibility (CF) these are the key domains of the executive function (EF) in basketball players (BP). This single-scale CEFI will give the overall status of BP. The floor and ceiling effects can be calculated from the total score. The scale will help in the documentation of the change in score domains and total score. This development of this scale’s items and domains involves a systematic literature review and structured interviews, which will help reduce the likelihood of overlooking important items. This approach aims to establish the scale as a highly effective tool for documenting patient outcomes in India. |