| CTRI Number |
CTRI/2025/12/099532 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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 Check Whether Lego Blocks Play Can Help to Improve Hand Skills in Children with Autism |
|
Scientific Title of Study
|
Effectiveness of Lego Based Therapy on Hand 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 |
Naima Khot |
| Designation |
PG student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy, |
| Address |
Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9405009315 |
| Fax |
|
| Email |
naimakhot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Pimpale |
| Designation |
Professor and HOD |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082194223 |
| Fax |
|
| Email |
drsatishpimpale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Pimpale |
| Designation |
Professor and HOD |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082194223 |
| Fax |
|
| Email |
drsatishpimpale@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naima Khot |
TMVs Lokmanya Tilak College of Physiotherapy |
Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9405009315
naimakhot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMvs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee (Academic) |
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 |
Improving hand function using
Lego based therapy |
Lego based exercises of hand function in children with Autism Spectrum Disorder Group A protocol will be given for 45 minutes 3 days a week for 4 weeks |
| Comparator Agent |
Improving hand function using Conventional exercises |
Conventional exercises of hand function in children with Autism Spectrum Disorder Group B protocol will be given for 45 minutes 3 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Child is 6 to 12 years old
2. Child has an ASD diagnosis confirmed by Indian Scale for Assessment of Autism (ISAA)
3. Child has isolated thumb and fingers movement possible
4. Child is able to follow simple instructions |
|
| ExclusionCriteria |
| Details |
1. Child is diagnosed as severe autism
2. Child has definite sensory difference by Short Sensory Profile
3. Child has any other medical condition
4. Child has auditory, visual impairments or hand deformities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment In-Hand Manipulation |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 Applicable |
| 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 is a randomized controlled trial exploring the effect of Lego based therapy and Conventional exercises on in hand manipulation skills in children with Autism Spectrum Disorder. Assessment In-Hand Manipulation will be used as primary outcome measure to assess the in hand manipulation skills pre and post intervention. Children will be allocated by lottery method under Group A and Group B. Group A will be given Lego based therapy and Group B will be given Conventional exercises for 45 minutes, 3 days a week for 4 weeks. |