| CTRI Number |
CTRI/2025/08/093132 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing How Easy and Reliable It Is to Use CogniFit a digital tool for Assessing Cognition in Older Adults |
|
Scientific Title of Study
|
Feasibility and Reliability of CogniFit, A Digital Cognitive
Assessment Battery in Older Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik U |
| Designation |
Post Graduate student |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala
Manjunatheshwara College Of Medical Science and Hospital,
Manjushree Nagar Sattur, Dharwad.
MANJUSHREE NAGAR SATTUR DHARWAD-58009
Dharwad
KARNATAKA
580009
India |
| Phone |
8746055523 |
| Fax |
|
| Email |
karthikurs98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik U |
| Designation |
Post Graduate student |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala
Manjunatheshwara College Of Medical Science and Hospital,
Manjushree Nagar Sattur, Dharwad.
MANJUSHREE NAGAR SATTUR DHARWAD-58009
Dharwad
KARNATAKA
580009
India |
| Phone |
8746055523 |
| Fax |
|
| Email |
karthikurs98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHARMILA D |
| Designation |
Professor and PG guide |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM College of Physiotherapy
SDM University Sattur Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9880950990 |
| Fax |
|
| Email |
sharmila.dudhani@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KARTHIK U |
| Address |
#1966
Shridharmashatha
Vanasiri nagar, sattur
Dharwad - 580009. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SHARMILA D |
SDM COLLEGE OF PHYSIOTHERAPY |
OPD NO.05
Neurophysiotherapy
Department Shri
Dharmasthala
Manjunatheshwara
College Of Medical
Science and Hospital,
Manjushree Nagar
Sattur, Dharwad.
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
9880950990
sharmila.dudhani@sdmuniversity.edu.in |
| Karthik U |
SDM COLLEGE OF PHYSIOTHERAPY |
OPD NO.05
Neurophysiotherapy
Department Shri
Dharmasthala
Manjunatheshwara
College Of Medical
Science and Hospital,
Manjushree Nagar
Sattur, Dharwad.
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
8746055523
karthikurs98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE IEC-SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy older adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a.Age- 60 years and above.
b.Participants of either gender will be included.
c.Participants familiar with English language. |
|
| ExclusionCriteria |
| Details |
a.Participants who are non-co-operative.
b.Participants with medical history of diabetes and
hypertension.
c.Elderly individuals with Neurological or
Psychiatric Disorders.
d.Inability or refusal to use computer-based tools
necessary for completing CogniFit GCAB.
e.Significant visual and auditory impairments that
would interfere with completing CogniFit GCAB.
f.People who find it difficult to use or manipulate a
mouse.
g.Fracture injury of dominant hand in past 3
months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The Montreal Cognitive
2. Assessment (MoCA)
AttrakDiff Questionnaire |
1. The Montreal Cognitive Assessment (MoCA) will be assessed at BASELINE
2. AttrakDiff Questionnaire will be assessed at 3RD WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/08/2025 |
| 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) |
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
|
As the elderly population in India continues to grow, there is an increasing need for accessible and
reliable cognitive assessments to detect early signs of cognitive decline. Traditional assessment
methods often have limitations in terms of accessibility, cost, and sensitivity to subtle cognitive
changes. This highlights the urgent need for innovative tools that can provide consistent, accurate, and
cost-effective evaluations of cognitive function, particularly for older adults who may face challenges
in attending in-person assessments. The CogniFit Cognitive Assessment Battery, a digital platform
offering reliable cognitive evaluations, holds promise in addressing these challenges. However, its
feasibility and reliability in the Indian context, especially among older adults, remains underexplored.The aging population in India, projected to reach 347 million individuals aged 60 and older by 2050,
necessitates the development of efficient and scalable tools for cognitive screening. The CogniFit
Cognitive Assessment Battery (CAB), an internationally validated digital tool, offers a potential
solution. However, there is limited research on its practical implementation in India, particularly in
terms of its feasibility and intra-rater and test-retest reliability with older adults. This study is critical in
determining whether the CogniFit CAB can be effectively integrated into the care practices for older
adults in India, particularly for those who face barriers to traditional healthcare settings. By examining
these factors, the study aims to assess the potential of CogniFit to facilitate early cognitive assessments
and support healthcare initiatives in India’s aging population. This study is among the first in India to assess the feasibility and intra-rater and test-retest reliability of
the CogniFit Cognitive Assessment Battery in older adults. Unlike most existing research, which focuses
on cross-sectional comparisons or tool adaptation, this study evaluates the practical implementation and
reliability of a digital cognitive tool in real-world settings. By introducing an internationally validated
digital tool in a culturally diverse aging population, the study could pave the way for large-scale cognitive
screening and personalized digital health interventions in India. |