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CTRI Number  CTRI/2025/12/099072 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 30/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The study exploring the effects of occupational therapy interventions combining fundamental motor skill training on performance in activities of daily living in children with autism spectrum disorder (ASD) 
Scientific Title of Study   To explore the effects of occupational therapy interventions combining fundamental motor skill training on functional performance in children with autism spectrum disorder (ASD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jolly Gupta Jain 
Designation  PhD Scholar 
Affiliation  Santosh deemed to be university 
Address  Basement, Department of occupational therapy, Santosh Deemed to be University No.1, Santosh Nagar, Pratap Vihar, Ghaziabad
2nd Floor, OPD, Department of occupational therapy, Santosh Hospitals Ambedkar Rd, Maliwara, Nehru Nagar, Ghaziabad, Uttar Pradesh 201001
Ghaziabad
UTTAR PRADESH
201009
India 
Phone  8447563723  
Fax    
Email  jolly.otist@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R K Sharma 
Designation  Principal, Santosh Occupational Therapy 
Affiliation  Santosh Deemed to be University 
Address  Santosh Deemed to be University No.1, Santosh Nagar, Pratap Vihar, Ghaziabad,

Ambedaker Nagar
UTTAR PRADESH
201009
India 
Phone  9811147423  
Fax    
Email  kumarrk52003@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr R K Sharma 
Designation  Principal, Santosh Occupational Therapy 
Affiliation  Santosh Deemed to be University 
Address  Basement, Department of occupational therapy, Santosh Deemed to be University No.1, Santosh Nagar, Pratap Vihar, Ghaziabad
2nd Floor, Department of occupational therapy, Santosh Hospitals Ambedkar Rd, Maliwara, Nehru Nagar, Ghaziabad, Uttar Pradesh 201001
Ambedaker Nagar
UTTAR PRADESH
201009
India 
Phone  9811147423  
Fax    
Email  kumarrk52003@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Santosh Deemed to be university 
Address  Basement,Department of occupational therapy, Santosh Deemed to be University No.1, Santosh Nagar, Pratap Vihar, Ghaziabad 
Type of Sponsor  Private medical college 
 
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 
Prof Dr R K Sharma   Santosh Hospital  2nd Floor, OPD, Department of occupational therapy, Ambedkar Rd, Maliwara, Nehru Nagar, Ghaziabad, Uttar Pradesh 201001
Ghaziabad
UTTAR PRADESH 		 9811147423

kumarrk52003@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics committee of santosh Deemed to be university  Approved 
Ethics committee of santosh Deemed to be university  Approved 
Ethics committee of santosh Deemed to be university  Approved 
ethiocs committee of santosh deemed to be university  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 
Comparator Agent  Occupational Therapy Intervention   Occupational Therapy intervention which includes conventional occupational therapy approach such as sensory integration therapy, motor training and ADL Intervention for habituation. The duration for the therapy will be for 12 weeks for 4 days a week. therapy session duration will be for 40 to 45 minutes each.  
Intervention  Occupational Therapy Intervention combining Fundamental motor skill training   Occupational Therapy Intervention combining Fundamental motor skill training will be provided as a new intervention. Fundamental motor skill training includes walking, running, jumping, reaching, catching, and throwing. The duration for the therapy will be for 12 weeks for 4 days a week. therapy session duration will be for 60 minutes each. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  The Indian Scale for Assessment of Autism (ISAA) was used as a screening tool to confirm ASD, with eligible participants scoring between 70 and 153: normal or corrected vision and hearing, intact airways, and no history of uncontrolled seizures. Written informed consent was obtained from parents or legal guardians before participation.  
 
ExclusionCriteria 
Details  Children with additional physical or intellectual disabilities, congenital anomalies, metabolic disorders, or other comorbid conditions were excluded from the study.Children demonstrating poor compliance with therapy sessions were subject to withdrawal based on predefined criteria. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
An innovative treatment protocol for ASD to improve functional performance.  8 to 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   30/12/2025 
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="1"
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  Data will be shared directly with the journal editorial office or peer reviewers upon request during the manuscript submission and review process. Data will not be made publicly available or stored on a third-party platform.

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
It is an innovative treatment therapy protocol designed to explore effectiveness on autism spectrum children by providing them conventional Occupational therapy intervention program along with fundamental motor skill training and checking its effect on their functional performance.
  
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