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CTRI Number  CTRI/2025/11/097549 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To check the Effect of Play Based Exercises and Free Play on few executive functions on children between 3-5 years using Attention Deficit Hyperactivity Disorder Rating Scale IV (Preschool Version)- A Comparative Study 
Scientific Title of Study   Effect of Play Based Exercises and Free Play on Cognitive Flexibility and Inhibitory Control using Attention Deficit Hyperactivity Disorder Rating Scale IV (Preschool Version)- A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Ghate  
Designation  Associate Professor 
Affiliation  Smt. Kashibai Navale College of Physiotherapy 
Address  Department of Neurophysiotherapy Smt.Kashibai Navale College of Physiotherapy Survey No. 49/1 Off Westerly Bypass, Narhe Pune

Pune
MAHARASHTRA
411041
India 
Phone  9527745023  
Fax    
Email  shrutighate.skncopt@sinhgad.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Shilpa Khandare 
Designation  Professor 
Affiliation  Dr.DY Patil College of Physiotherapy 
Address  Dr. D.Y.Patil College of Physiotherapy 190,Dr DY Patil College Road, Sant Tukaram Nagar,Pimpri Colony,Pimpri-Chinchwad

Pune
MAHARASHTRA
411041
India 
Phone  08149853651  
Fax    
Email  shilpa.khandare@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Shruti Ghate  
Designation  Associate Professor 
Affiliation  Smt. Kashibai Navale College of Physiotherapy 
Address  Department of Neurophysiotherapy Smt.Kashibai Navale College of Physiotherapy Survey No. 49/1 Off Westerly Bypass, Narhe Pune

Pune
MAHARASHTRA
411041
India 
Phone  9527745023  
Fax    
Email  shrutighate.skncopt@sinhgad.edu  
 
Source of Monetary or Material Support  
Department of Neurophysiotherapy Smt.Kashibai Navale College of Physiotherapy Survey No.49/1, Narhe , Off Mumbai Pune Bypass, Pune 411041 
 
Primary Sponsor  
Name  Smt. Kashibai Navale college of Physiotherapy 
Address  Department of Neurophysiotherapy Survey No.49/1 Narhe Pune 411041 
Type of Sponsor  Research institution and hospital 
 
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 
Shruti Ghate   Sinhgad Spring Dale Public School  Sinhgad Spring Dale Public School Primary Kindergarden Section Survey No 44/1, Off Sinhgad Road, Wadgaon Budruk
Pune
MAHARASHTRA 
9527745023

shrutigghate@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Comittee of D.Y.Patil College of Physiotherapy  Approved 
Local NOC Singad Springdale School  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Attention Deficit Hyperactivity Disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Free Play  Unstructured outdoor and indoor free play activities for children 
Intervention  Play Based Exercises  Week 1:Orientation & Engagement Week 2: Working Memory Week 3: Inhibitory Control Week 4:Cognitive Flexibility Week 5: Combination: Working Memory & Inhibitory Control Week 6: Working Memory-Build & Recall Week 7: Inhibitory Control Week 8: Cognitive Flexibility Week 9: Flexibility & Memory Week 10: (Introduction to Group)-Circle Recall Week 11:Reflection- Group Challenges Week 12: Favorite Activity Replay  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Preschoolers of age group of 3 to 5 years
Both boys and girls
Parents or caregivers who have a basic understanding of English language
 
 
ExclusionCriteria 
Details  Previously diagnosed neurological cardiovascular or musculoskeletal disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
ADHD rating scale IV preschool version
Day and Night Task
Dimensional Change Card Sort (DCCS) 
week 1  
 
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)   01/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

·       Executive functions in early childhood are critical predictors of academic success, social development, and long-term mental health Notably, early childhood, specifically the ages of 3 to 7 is a period of notable and rapid development in Executive Functions Zelazo et al 2003.

·       Play is a natural engaging and developmentally appropriate medium for pre-schoolers. It fosters intrinsic motivation social interaction and cognitive engagement which are essential for EF improvement.

·       While playbased interventions have shown promise limited studies explore their structured application specifically for pre-schoolers with ADHD symptoms.

PROCEDURE:

       Approval will be obtained from the Ethics committee and Review Board. Each parent or caregiver will be given detailed information and written informed consent will be taken prior to the study.

       Subjects will be screened as per the inclusion and exclusion criteria.

       Screening process will be done and consent will be taken from the Head of school and parents will be informed about the same during the school parents teachers meeting.

       The data collection will be done in two rounds.

 

 

 

ROUND 1

1A group of 15 to 20 parents or caregivers will be addressed the ADHD Rating Scale will be explained and given to the parents to fill details of specific components after which the scale will be returned to the Therapist.

2 The Parents will be informed that the scale will be scored and Parents will be informed regarding the outcome of the score.

 

ROUND 2

Parents/caregivers of the children exhibiting ADHD symptoms will be contacted for the second data collection round. Day and Night Task and Dimensional Change Card Sort DCCS will be administered and scoring will be done.

Children will be randomly allocated in Play Based Exercise group and Free Play group for a period of 12 weeks after which post scores of the scales will be recorded.

 

Intervention

       Total time:

       Duration 3 times a week for 12 weeks.

       Group A Play Based Therapy Group

       Play based exercises for 30 minutes followed by 15 minutes of free Play.

       Week 1

       Orientation & Engagement 1. Follow the Leader: Mimic leader’s actions to practice attention and inhibitory control.

                 2. Name Game: Memory exercise

       Week 2 Working Memory Memory Match: Classic card game with animal pairs.
- Story Chain: Therapist creates a story with child and therapist adding one sentence alternatively.

       Week 3 Inhibitory Control-Simon Says: Action following game.
 Freeze Dance: Dance to music and freeze when it stops.

       Week 4 Cognitive Flexibility Sorting Colors and Shapes Sort items based on changing criteria.
- Opposites Game Respond with opposite actions e.g clap when instructed to be still.

       Week5  Combination Working Memory & Inhibitory Control Story Memory Game Listen to a story answer questions afterward.
Obstacle Course with Rules Follow changing rules e.g stop at red

       Week 6 Working Memory-Build & Recall Build structures with blocks and then replicate them.
 Pattern Game Repeat sequences e.g clap tap clap.

       Week 7 Inhibitory Control-Opposite Simon Says Adds complexity to Simon Says by using opposite commands.
Balloon Tap Keep a balloon afloat without over-hitting or dropping it.

       Week 8 Cognitive Flexibility Puzzle Hunt Solve puzzles requiring different approaches.

       Week 9 Flexibility & Memory Rule Switch Dance Dance changes based on verbal instructions.
 Treasure Hunt with Clues: Follow multi-step instructions to find a hidden object.

       Week 10 Introduction to GroupCircle Recall Recall a sequence of actions from peers.
 Stop and Go Run when Go is called freeze on Stop add memory based cues for variety

       Week 11Reflection Group Challenges Group problem solving games like building towers.
 Role Playing Scenarios Simulate tasks that require planning and decision making.

       Week 12 Favorite Activity Replay Revisit favorite games from the protocol.
Reflection Circle Share what they enjoyed most and learned.

       Intervention Group B  Free Play will be given to the children during the same time.

 

 

Consort Chart:

 

 

 

 

 
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