| CTRI Number |
CTRI/2025/07/091727 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| 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
|
A study to compare virtual reality-based training and conventional physiotherapy to improve motor skills in children with autism |
|
Scientific Title of Study
|
Effectiveness of Virtual and Augmented reality-based training versus conventional physiotherapy on sensorimotor skills 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 |
Srilakshmi J |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R.Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R.Educational and Research Institute, ACS Medical College and Hospital.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9384818429 |
| Fax |
|
| Email |
srilakshmi.physio@drmgrdu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVeenakirthika S |
| Designation |
Joint Registrar and Vice Principal |
| Affiliation |
Faculty of Physiotherapy, Dr. M.G.R Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R.Educational and Research Institute, ACS Medical College and Hospital.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9384818429 |
| Fax |
|
| Email |
veena.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Srilakshmi J |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Physiotherapy, Dr. MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R Educational and Research Institute, ACS Medical College and Hospital.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
09384818429 |
| Fax |
|
| Email |
srilakshmi.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Dr. MGR Educational and Research Institute, ACS Medical College and Hospital. Vellapanchavadi, Chennai, Tamil Nadu, India
pincode : 600077 I |
|
|
Primary Sponsor
|
| Name |
Srilakshmi J |
| Address |
Faculty of Physiotherapy, Dr. M.G.R.Educational and Research Institute, ACS Medical College and Hospital.Vellapanchavadi,Chennai, Tamilnadu, India.
pincode : 600077 |
| Type of Sponsor |
Other [other (self)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSrilakshmi J |
Faculty of physiotherapy, ACS medical college and hospital |
Outpatient Department, Faculty of Physiotherapy, ACS Medical College and Hospital, Vellapanchavadi, chennai -77
Thiruvallur
TAMIL NADU |
9384818429
srilakshmi.physio@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr.M.G.R. Educational and Research Institute. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Virtual and augmented reality-based sensorimotor training |
Virtual and augmented reality-based sensorimotor training was given for 60 min/day for 5 days a week for 12 weeks by using VR headset applications under therapist supervision. |
| Comparator Agent |
Group 2: Conventional physiotherapy for sensorimotor skills |
Conventional physiotherapy for sensorimotor skills will be given for 60 min/day for 5 days a week for 12 weeks. In-person physiotherapist using traditional motor skill training techniques will be given. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to 12 years
2. Diagnosed with Autism Spectrum Disorder according to medical report and classified by ISAA 107 (Moderate)
3. Both genders.
4. Cognitive Functioning Level: Participants must possess a minimum level of cognitive functioning to engage with the VR training exercises. FSIQ score of 70 or above.
5. Participants should have the ability to tolerate and use virtual reality technology.
6. Children who could walk independently and follow simple instructions |
|
| ExclusionCriteria |
| Details |
1. Participants with severe cognitive, behavioral, or clinical limitations that prevent them from following instructions and safely participating in group physical activity.
2. Who have undergone surgery or fractures in the last 6 months.
3. Parents self-reported mental illness or substance abuse.
4. Children with severe visual or hearing impairments
5. Coexisting neurological conditions like epilepsy
6.Recent orthopedic surgeries |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
fine motor skill, in-hand-eye coordination, dexterity, and precision in tasks such as object manipulation and manual tasks
|
Baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of virtual & augmented reality-based training versus conventional physiotherapy on salivary biomarkers, gross motor skill improvement, & fine motor skill development in children with ASD. |
Baseline, 4 weeks, 8 weeks & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="6"
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
|
This study was conducted in the Faculty of Physiotherapy pediatric outpatient department equipped with VR/AR systems. The aim was to compare the impact of immersive digital training methods with conventional physiotherapy on improving sensorimotor skills in children with Autism Spectrum Disorder (ASD). Children aged 6 to 12 years, diagnosed with ASD, who could walk independently and follow simple instructions, were included in the study. Exclusion criteria involved children with severe visual or hearing impairments, coexisting neurological conditions like epilepsy, recent orthopedic surgeries, or significant behavioral issues preventing VR participation. Participants were divided into two groups: one receiving virtual and augmented reality-based sensorimotor training, and the other undergoing conventional physiotherapy. Outcome measures focused on evaluating gross and fine motor skills (using tools like the AMAS), sensory integration abilities (assessed with scales such as the Sensory Profile), and Biomarkers for functional performance,VABS to assess adaptive behavior; and the 6-minute walk test to assess endurance and walking ability before and after the intervention period.
|