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CTRI Number  CTRI/2025/05/087872 [Registered on: 29/05/2025] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Technology]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of an AI-based learning platform in children with Autism Spectrum Disorder, Developmental Delay, and Intellectual disability 
Scientific Title of Study   An Intervention-Based single blind study to evaluate the effectiveness of an Al based learning platform in enhancing skills in cognitive development, enhancing social relationships, improving speech, language, and communication and addressing sensory aspects in children with autism spectrum disorder, intellectual disability and developmental delay 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maj Dr B V Ram Kumar 
Designation  Director 
Affiliation  National Institute for the Empowerment of Persons with Intellectual Disabilities 
Address  National Institute for the Empowerment of Persons with Intellectual Disabilities; Manovikasnagar, Bowenpally, Secunderabad, Telangana Ph: 040-27751741 Ext : 222

Hyderabad
TELANGANA
500009
India 
Phone  04027751741  
Fax    
Email  dir@nimhindia.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajvir Rao 
Designation  Content Reviewer 
Affiliation  Cognitivebotics Technologies Private Limited 
Address  6th FLOOR, TSIIC, MYHOME TWITZA, Rai Durg

Hyderabad
TELANGANA
500081
India 
Phone  7893855499  
Fax    
Email  support@cognitivebotics.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajvir Rao 
Designation  Content Reviewer 
Affiliation  Cognitivebotics Technologies Private Limited 
Address  6th FLOOR, TSIIC, MYHOME TWITZA, Rai Durg

Hyderabad
TELANGANA
500081
India 
Phone  7893855499  
Fax    
Email  support@cognitivebotics.com  
 
Source of Monetary or Material Support  
Cognitivebotics Technologies Private Limited 6th Floor, My Home Twitza TSIIC Raidurg, Hyderabad 500081, Telangana, India 
 
Primary Sponsor  
Name  Cognitivebotics Technologies Private Limited 
Address  6th FLOOR, TSIIC, MYHOME TWITZA, Rai Durg, Telangana 500081 
Type of Sponsor  Other [Ed-Tech] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajvir Rao  National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID)  National Institute for the Empowerment of Persons with Intellectual Disabilities, Manovikasnagar, Bowenpally, Secunderabad, Telangana 500009
Hyderabad
TELANGANA 		 7893855499

support@cognitivebotics.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Global Independence Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F845||Aspergers syndrome, (2) ICD-10 Condition: F840||Autistic disorder, (3) ICD-10 Condition: R620||Delayed milestone in childhood, (4) ICD-10 Condition: F70||Mild intellectual disabilities, (5) ICD-10 Condition: F71||Moderate intellectual disabilities, (6) ICD-10 Condition: R625||Other and unspecified lack of expected normal physiological development in childhood, (7) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, (8) ICD-10 Condition: F89||Unspecified disorder of psychological development,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control (6 months)  Subjects with a mild to moderate level of developmental delay, intellectual disability and/or autism, who are currently receiving conventional therapy alone for 6 months. 
Intervention  Experimental (6 months)  For 6 months the particpant will use the AI-based CognitiveBotics platform for a Minimum of four sessions per week, each lasting 30-minutes, alongside their regular learning activities or conventional therapies. The therapist, through the platform, is enabled to offer personalized, adaptive content based on the child’s learning progress. 
 
Inclusion Criteria
Modification(s)  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Children with a Mental Age of 2 to 6 years or a chronological age of 2 to 8 years.
2. Children with mild to moderate levels of developmental delay or intellectual disability and Autism Spectrum Disorder and are currently undergoing conventional therapy.
3. Children who are able to engage in short duration digital activities with parental guidance.
4. Parents who have access to touch based laptops, tablets, or smartphones with a good internet connection.
5. Parents or caregivers must provide informed consent and be willing to support the child s participation. 
 
ExclusionCriteria 
Details  1. Children with severe cognitive impairment and/or co-occurring neurological disorders.
2. Presence of comorbid conditions that might impact cognitive or physical functioning.
3. Children with sensory impairments that prevent them from using the AI-based learning platform (e.g., blindness, severe hearing loss).
4. Children with the diagnosis of ADHD.
5. Parents or caregivers who wouldn’t consent to be part of the study.
6. Parents or caregivers unwilling to comply with therapy schedules or follow-up assessments.
7. Parents who do not meet the requirements for the device specifications to be part of the study.
8. Children who are currently enrolled in an ongoing clinical trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that children in the Experimental group will show
measurable improvements in cognitive, social, and communication skills compared to the control group.
The AI-based learning platform is anticipated to promote skill
acquisition in children who can engage with structured digital
learning experiences. 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/06/2025 
Date of Study Completion (India) 09/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  Nil
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [support@cognitivebotics.com].

  6. For how long will this data be available start date provided 23-04-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Brief Introduction: The aim of this research is to evaluate the effectiveness of an AI-based learning platform in enhancing skills in cognitive development, enhancing social relationships, improving speech, language, and communication and addressing motor aspects in children with Autism Spectrum Disorder (ASD), Developmental Delay (DD) and Intellectual disability (ID).
Existing Gaps: Conventional therapies, though effective, face challenges related to therapy availability, therapist-child ratios, consistency in therapy, and parental involvement. The current gap lies in scalable, accessible, and personalized interventions that can supplement conventional therapy. While digital solutions are emerging, data on their scientific validation remains sparse, particularly in the Indian context.
Justification for Study: The proposed study aims to evaluate the feasibility and effectiveness of an Artificial Intelligence (AI)-based learning platform—CognitiveBotics—as a supplementary intervention tool for children with mild to moderate ASD, DD, and ID. By leveraging technology, this study proposes a structured and measurable digital intervention that can enhance therapy access and outcomes.
 
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