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CTRI Number  CTRI/2025/07/091927 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Aquatic Therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How Swimming Can Help Children with Special Needs 
Scientific Title of Study   Effectiveness of Aquatic Intervention on Motor Coordination and Behavioral Outcomes in Children with Autism Spectrum Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Iffat Ara Nasrin Chaity 
Designation  Postgraduate student  
Affiliation  Jashore University of Science and Technology  
Address  Room - 303, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801301779767  
Fax    
Email  iffataranasrinchaity@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Feroz Kabir  
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room no: 405, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Feroz Kabir  
Designation  Assistant Professor 
Affiliation  Jashore University of Science And Technology 
Address  Room no: 405, Department of Physiotherapy and Rehabilitation , Jashore University of Science and Technology



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd   
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Level 2 and 3, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
 
Primary Sponsor  
Name  Department of Physiotherapy and Rehabilitation 
Address  Room - 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumaya Sultana   PROYASH Institute of Special Education, Jashore Branch  Jashore Cantonment, Jashore-7400, Bangladesh

 		 8801684416476

sumayasultana404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy & Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aquatic Therapy + Standard Care  Total duration: 12 weeks. This group will receive: Aquatic Therapy: 2 sessions per week, each 45 minutes. Includes warm-up, orientation training, free swim activities, and cool-down. Activities focus on motor coordination and behavioral improvements in children with Autism Spectrum Disorder (ASD). Standard Care: 2 sessions per week, each 45 minutes. Includes occupational therapy, speech therapy, and regular community-based therapy. 
Comparator Agent  Standard Care  Total duration: 12 weeks. This group will receive: Standard Care: 2 sessions per week, each 45 minutes. Includes occupational therapy, speech therapy, and regular community-based therapy, following standard rehabilitation practices to improve motor skills and communication.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children diagnosed with Autism Spectrum Disorder (ASD) (Level 1 or 2, DSM-5 criteria)

Able to follow basic instructions and participate in aquatic activities

Parental consent obtained for participation. 
 
ExclusionCriteria 
Details  Children with uncontrolled seizures or any medical conditions contraindicated for aquatic therapy

Children with a fear of water or inability to tolerate aquatic environments 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Motor Coordination by BOT-2  Baseline, 6 weeks, and 12 weeks post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Behavioral Outcomes by ABC  Baseline, 6 weeks, and 12 weeks post-intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
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

  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 [feroz@just.edu.bd].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized controlled trial will be conducted to evaluate the effectiveness of aquatic intervention on motor coordination and behavioral outcomes in children with autism spectrum disorder (ASD). Participants aged 5–12 years with ASD (Level 1 or 2, based on DSM-5 criteria) will be assigned to either an aquatic therapy group (involving structured swimming and water-based exercises) or a control group (receiving standard care). The primary outcome will be motor coordination, which will be assessed using the BOT-2, while the secondary outcome will focus on behavioral symptoms, assessed by the ABC. The study will hypothesize that aquatic intervention will significantly improve motor skills and reduce behavioral challenges compared to standard care.

 
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