| CTRI Number |
CTRI/2025/11/096943 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Multimodal Intervention in Children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effectiveness of a Five-Component Multimodal Intervention on Executive Function in Children with Autism Spectrum Disorder: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Graduate student |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Graduate student |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Graduate student |
| Affiliation |
Jashore University of Science and Technology (JUST) |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology,Jashore -7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore -7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore -7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraiya Yesmin Sharna |
Dr. M R Khan Medical Centre |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
|
01786395080
sharnajust1019@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of the Department of Physiotherapy & Rehabilitation at Jashore University of Science & Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Experimental group |
The intervention will consist of a 12-week small-group structured exercise program, conducted five times per week for 60 minutes per session. Each participant will also follow a healthy lifestyle and adhere to nutritional guidelines. It incorporates five evidence-based components designed to address the multidimensional needs of children with ASD—physical fitness, cognitive engagement, emotional regulation, and social participation. Each session includes 10 minutes of yoga to enhance flexibility and self-regulation; 15 minutes of aerobic activity to improve cardiovascular fitness and mood stability; 10 minutes of strengthening exercises targeting major muscle groups; 15 minutes of neurocognitive tasks promoting attention and executive functioning; and 10 minutes of music-based mindfulness to support relaxation and social interaction. The program will progressively adapt to individual ability levels to ensure safety, engagement, and sustainable improvement in overall quality of life. |
| Comparator Agent |
Healthy control group |
Healthy participants in this group will not receive any intervention during the entire 24-week study period. They will be instructed to maintain a healthy lifestyle and follow nutritional guidelines based on provided booklet. |
| Comparator Agent |
Wait-list control group |
Participants in this group will not receive any intervention during the initial 12-week period. They will be instructed to maintain a healthy lifestyle, follow nutritional guidelines, and refrain from participating in any additional exercise programs or interventions that could influence study outcomes. To ensure adherence, participants and their caregivers will be contacted weekly for brief check-ins regarding physical activity and health status. After the 12-week intervention, the control participants will also have the option to receive the intervention of the experimental group.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Male |
| Details |
Participants will be included if aged between 4 and 18 years, including both boys and girls, who will have been diagnosed with Autism Spectrum Disorder (ASD) in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), based on clinical assessment and confirmed by evaluation using the Childhood Autism Rating Scale, Second Edition (CARS-2), conducted by a child psychiatrist. Consent to participate in a 12-week intervention period. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have cerebral palsy, Down syndrome, or attention deficit/hyperactivity disorder (ADHD). Additionally, any participant who reports, or whose parent reports, a recent (within the past six months) muscle injury or other conditions—such as muscle sprain, head injury, or skin laceration—that may interfere with study outcomes or exercise participation will also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Executive Function: Inhibitory Control (IC) - Go/No-go (GNG) task; Cognitive Flexibility (CF) - Trail Making Test A–B; Working Memory (WM) - Corsi block tapping task (CBTT), Forward digit span test (FDS), and Backward digit span test (BDS). |
At baseline, week-12, and week-24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Social Responsiveness Scales Second Edition (SRS-2),
Autism Treatment Evaluation Checklist (ATEC) |
At baseline, week-12, and week-24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="195"
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)
|
17/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
Modification(s)
|
This randomized controlled trial will investigate the effectiveness of a 12-week, five-component multimodal intervention on executive function in children with Autism Spectrum Disorder (ASD). A total of 112 participants aged 4–18 years will be randomly assigned to either an intervention or a wait-list control group. 65 children without ASD will also be recruited as a healthy control group. The program integrates yoga, aerobic exercise, strengthening, neurocognitive tasks, and music-based mindfulness. Primary outcomes include executive function measures, while secondary outcomes assess social responsiveness and autism-related behaviors at baseline, 12, and 24 weeks. |