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CTRI Number  CTRI/2024/07/070209 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 22/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Combined Rehabilitation Therapy for Children with ASD 
Scientific Title of Study   Efficacy of Combined Therapy for 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  Md Sherajul Haque 
Designation  MPT in Pediatrics (Fellow) 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801953970306  
Fax    
Email  sherajphysio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh.  
 
Primary Sponsor  
Name  Md Sherajul Haque 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh.  
Type of Sponsor  Other [Self-funded] 
 
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 Md Kabir Hossain  Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh.  Room no: 306, 2nd floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh.

 		 01778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Department of Physiotherapy and Rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F989||Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combined Therapy  Physiotherapy 30 minutes 1. Land-based & swimming-based exercises 2. Gait training 3. Coordination practice 4. Hippo-therapy or therapeutic horse riding 5. Gross motor function practice 6. Proprioception training 7. Aerobic exercise training 8. Muscle strengthening Occupational therapy 30 minutes 1. Setting up the space 2. Providing 3. Offering options 4. Modifying activities 5. Assuring the success of activities 6. Providing direction 7. Establishing a fun atmosphere 8. Choosing an activity together 9. Encouraging therapeutic partnerships 10. Achieving and preserving appropriate arousal levels Speech and Language therapy 30 minutes 1. Applied Behavior Analysis (ABA) 2. Applied Behavior Consequence (ABC) 3. Relationship Development Intervention (RDI) 4. Cognitive Behavior Intervention (CBI) 5. Social communication intervention (e.g. Social Story) 6. Picture Exchange, Communication System (PECS) 7. Augmentative and alternative communication (AAC) 8. Visual schedule Physiotherapy, Occupational Therapy, Speech and Language Therapy. Each session will be 30 minutes, 3 days a week up to 4 weeks.  
Comparator Agent  Control Therapy   Occupational therapy 45 minutes 1. Setting up the space 2. Providing 3. Offering options 4. Modifying activities 5. Assuring the success of activities 6. Providing direction 7. Establishing a fun atmosphere 8. Choosing an activity together 9. Encouraging therapeutic partnerships 10. Achieving and preserving appropriate arousal levels Speech and Language therapy 45 minutes 1. Applied Behavior Analysis (ABA) 2. Applied Behavior Consequence (ABC) 3. Relationship Development Intervention (RDI) 4. Cognitive Behavior Intervention (CBI) 5. Social communication intervention (e.g. Social Story) 6. Picture Exchange, Communication System (PECS) 7. Augmentative and alternative communication (AAC) 8. Visual schedule Occupational therapy and Speech and language therapy. Each session will be 45 minutes, 3 days a week up to 4 weeks.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  1. Diagnosed as Autism Spectrum Disorder children based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
2. Willing to participate
 
 
ExclusionCriteria 
Details  1. Respondents provided consent but dropped out within the first week of enrollment
2. Severe behavioral problems according to the Gilliam Autism Rating Scale (GARS-3)
3. Other children with neurodevelopmental disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Behavioral Status   1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Physical and Emotional health problems  1 Month 
 
Target Sample Size   Total Sample Size="70"
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)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2024 
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)
Modification(s)  		 Open to Recruitment 
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 - NO
Brief Summary  

We plan to conduct a five-week randomized controlled trial to evaluate the efficacy of combined regular therapy (physical therapy [PT], occupational therapy [OT], and speech-language therapy [SLT]) compared to specific therapy (OT and SLT) in children with autism spectrum disorder (ASD). Participants, aged 3-22 years, will be randomly assigned to one of two intervention groups: combined regular therapy (PT+OT+SLT) or specific therapy (OT+SLT). The interventions will be administered thrice a week over the five weeks. The study will involve within-group analysis to assess improvements from baseline in each group, focusing on motor skills, coordination, physical fitness, and overall functional abilities. Additionally, between-group comparisons will be conducted to determine the relative efficacy of combined regular therapy versus specific therapy. The primary outcome measure will be the improvement in motor skills, with secondary outcomes including enhancements in coordination, physical fitness, and functional abilities. Data will be collected at baseline and post-intervention, and statistical analyses will be performed to evaluate the results. This trial aims to provide evidence of the benefits of combined therapy approaches for children with ASD.

 
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