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CTRI Number  CTRI/2025/07/090071 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The Impact of Augmented Reality versus Physical Activity on Cognitive Abilities of Preschoolers. 
Scientific Title of Study   The Impact of Augmented Reality versus Physical Activity on Attention, Reaction Time and Visuospatial Skill on Preschoolers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ibtasham Nasir 
Designation  PG Student 
Affiliation  Jamia Hamdard 
Address  Department of Physiotherapy SNSAH, Jamia Hamdard Hamdard Nagar

South
DELHI
110062
India 
Phone  7278327144  
Fax    
Email  ibtasham.nasir@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Huma 
Designation  Assistant Professor 
Affiliation  Jamia Hamdard 
Address  Department of Physiotherapy SNSAH, Jamia Hamdard Hamdard Nagar

South
DELHI
110062
India 
Phone  8700027712  
Fax    
Email  humakhan@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Huma 
Designation  Assistant Professor 
Affiliation  Jamia Hamdard 
Address  Department of Physiotherapy SNSAH, Jamia Hamdard Hamdard Nagar

South
DELHI
110062
India 
Phone  8700027712  
Fax    
Email  humakhan@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Jamia Hamdard 
 
Primary Sponsor  
Name  Jamia Hamdard 
Address  Department of Physiotherapy SNSAH Jamia Hamdard Hamdard Nagar New Delhi-110062 
Type of Sponsor  Research institution 
 
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 
Ibtasham Nasir  Aravali Convent School  E-7/1, Ratiya Marg, Block E, Sangam Vihar
South
DELHI 		 7278327144

ibtasham.nasir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee (JHIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  None as such 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Augmented Reality  Session Structure: Catchy Words AR: Use of the AR app to engage children in moving around and catching letters to form words (15 minutes). QuiverVision: Colouring pages transforming into 3D animations to improve cognitive involvement. (15 minutes) The activities will target attention, reaction time, and visuospatial skills. Duration: 6 weeks Frequency: 3 sessions per week 
Intervention  Augmented Reality + Physical Activity  Session Structure: Warm-Up: Simon Says Stretch (5 minutes). Main Activity: Performing a combination of 10 minutes of physical activities (e.g., hopscotch, ball games) and 10 minutes of AR-based activities (Catchy Words AR or QuiverVision). Cool-Down: Breathing exercises (5 minutes). Duration: 6 weeks Frequency: 3 sessions per week 
Comparator Agent  Control  Children will engage in free play (unstructured activities) for the same duration as the other groups (30 minutes) Duration: 6 weeks Frequency: 3 sessions per week 
Intervention  Physical Activity  Session Structure: Warm-Up: Animal Walks or Simon Says Stretch (5 minutes). Main Activity: Performing of gross motor tasks such as the obstacle course, ball games, or hopscotch (20 minutes). Cool-Down: Breathing exercises (5 minutes). Duration: 6 weeks Frequency: 3 sessions per week 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Age: Preschoolers aged 4 to 6 years.
2. Health Status: Neurotypical development with no diagnosed cognitive or motor impairments.
3. Parental Consent: Written consent from parents or guardians to participate in the study.
4. Language Skills: Ability to understand basic instructions in the language used for the intervention and assessments.
5. Participation: Willingness to engage in both the AR and PA interventions as well as assessment tasks. 
 
ExclusionCriteria 
Details  1. Neurological or Developmental Disorders
2. Physical Limitations
3. Medication
4. Hearing or Vision Impairments
5. Behavioural Concerns
6. Participation in Similar Programs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of AR-based interventions and PA on attention, reaction time, and visuospatial skills in neurotypical preschoolers.  Baseline, 4 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the feasibility & effectiveness of AR-based interventions in neurorehabilitation for children with neurological or developmental impairments.  Baseline, 4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   15/07/2025 
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="0"
Months="1"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-01-2026 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  

Study Title:
The Impact of Augmented Reality versus Physical Activity on Attention, Reaction Time, and Visuospatial Skills in Preschoolers

Principal Investigator:
Ibtasham Nasir, MPT (Neurology), Department of Physiotherapy, Jamia Hamdard

Study Design:
Randomized Controlled Trial (RCT)

Objective:
To compare the effects of Augmented Reality (AR)-based interventions and Physical Activity (PA) on attention, reaction time, and visuospatial skills in neurotypical preschoolers.

Methodology:

  • Participants: 128 neurotypical preschoolers (aged 4-6 years) from preschools in New Delhi, randomly assigned to four groups (n=32 per group).
  • Groups:
    • Group A: AR-based intervention (Catchy Words AR & QuiverVision)
    • Group B: PA intervention (from the Physical Activity Toolkit for Preschool-Aged Children)
    • Group C: Combined AR + PA intervention
    • Group D: Control group (no intervention)
  • Intervention Duration: 6 weeks (3 sessions/week, 30 min/session)
  • Outcome Measures: Stroop Color Test, Simple Reaction Time Test, and Mental Rotation Task (assessed via PsyToolkit)
  • Statistical Analysis: Repeated measures ANOVA to compare group differences over time.

Ethical Considerations:
Approved by the Institutional Ethics Committee. Parental consent will be obtained before participation.

Significance:
Findings will contribute to understanding how AR and PA interventions enhance cognitive and motor development in preschoolers, informing early childhood education and neurorehabilitation strategies.

 
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