| CTRI Number |
CTRI/2024/04/066300 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the accuracy of a novel technology-enabled tool to identify the risk of dyslexia in children aged 6 to 10 years. |
|
Scientific Title of Study
|
Gaze Pattern Based Screening For Early Identification Of Risk Of Dyslexia In School Children. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Teena Ajit Paul |
| Designation |
Founder and CEO |
| Affiliation |
Giftolexia Solutions Private Limited |
| Address |
#677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru.
Bangalore KARNATAKA 560102 India |
| Phone |
7406722955 |
| Fax |
|
| Email |
teena@giftolexia.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nayanabai Shabadi |
| Designation |
Assistant Professor |
| Affiliation |
JSS Medical College, Mysuru |
| Address |
Department of Community Medicine, JSS Medical College, SS Nagar, Bannimantap, Mysuru-
Mysore KARNATAKA 570015 India |
| Phone |
8105828888 |
| Fax |
|
| Email |
nayanabaishabadi@jssuni.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Teena Ajit Paul |
| Designation |
CEO |
| Affiliation |
Giftolexia Solutions Private Limited |
| Address |
#677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru
Bangalore KARNATAKA 560102 India |
| Phone |
7406722955 |
| Fax |
|
| Email |
teena@giftolexia.com |
|
|
Source of Monetary or Material Support
|
| Giftolexia Solutions Private Limited, #677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru, Karnataka
560102
India |
|
|
Primary Sponsor
|
| Name |
Teena Ajit Paul |
| Address |
#677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru 560102. |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Nayanabai Shabadi |
JSS Medical College, Mysuru |
Department of Community Medicine, JSS Medical College, SS Nagar, Bannimantap, Mysuru-570015 Mysore KARNATAKA |
8105828888
nayanabaishabadi@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee JSS Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for Dyslexia in healthy children aged 6 to 10 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI-DST |
The screening involves use of a wearable eye tracking device with infrared cameras that
track the gaze pattern while children read grade appropriate text on a screen. We use an Eye Tracking device that is safe for use in children. A laptop runs the application that stores the Gaze Data of students. |
| Comparator Agent |
NIMHANS Battery. |
he NIMHANS Neuropsychological Battery for Children (Kar et al., 2004) consists of 13 previously developed tests that assess: Motor speed; Attention; Executive functions; Visuospatial functions; and Comprehension, learning, and memory. All of the tests included in the battery were either originally developed for or standardized on children in the West; there are norms for each test at each age level. In their India-based study with normal school-going children in the age range of 5–15 years, Kar et al. (2011) report that the test–retest reliability of all the tests falls in the range of 0.53–0.83, and that all of the tests have well-established construct validity. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. As participants are underaged, guardian consent and verbal consent from participant will be primary criteria for inclusion.
2.Participants should demonstrate a basic level of reading comprehension in the language the screening is conducted. |
|
| ExclusionCriteria |
| Details |
The following individual will be excluded:
1. non-consenting children.
2. Children with visual impairment.
3. Children with significantly below average intelligence.
4. Children with reading comprehension below the test threshold. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be measured as percent accuracy of the tool determined by comparison with an assessment tool, the NIMHANS Neuropsychological Battery for Children. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the safety of the device used by recording any negative outcomes. |
1 hour from test. |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
06/05/2024 |
| 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)
Modification(s)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Relevant data will be shared in a publication
- For how long will this data be available start date provided 15-02-2024 and end date provided 15-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dyslexia is a neurological disability that affects reading, spelling and language related learning. About 10 to 15% of the population is believed to be Dyslexic. People with Dyslexia are often perceived to be dull or lazy. On the contrary many famous inventors and scientists are believed to have been Dyslexic. People with Dyslexia are considered to be natural problem solvers and inventors. Early detection and intervention are crucial in tapping their full potential. The present testing processes are not standardized and is time consuming. We have developed a technology enabled screening tool based on gaze pattern analysis. We use a non- intrusive wearable eye tracking device to capture gaze data, a laptop stores the data. A smart IOT enabled screen or TV screen is used to calibrate the eyes and to project age and grade appropriate text which is read aloud by the child. Markers are extracted from the gaze data, and this is analyzed using machine learning algorithms. Multiple visualizations are also used for human interpretation, verification and correlation to arrive at the risk level of each child. This is an easier and faster screening method and is the best tool for class-wide screening as mandated by the RPWD Act This is age and language specific. The Rights to Persons with Disabilities Act 2016 talks about screening all children before the age of 9.This creates the need for a tech-enabled, standardized early screening tool. We use a globally recognized method of screening and offer the best solution for class-wide screening. Dyslexia is fundamentally a language-based learning disability, our results suggest that eye movements in reading can be highly predictive of individual reading ability and that eye tracking can be an efficient means to identify children at risk of long-term reading difficulties at an early age. This will help in early intervention and saves early crucial learning years and will lead to better learning and success in life. |