| CTRI Number |
CTRI/2026/03/105369 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Check Whether Lego Blocks Can Help to Improve Hand Manipulation Skills in Children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effect of Lego Therapy On Hand Manipulation Skills in Children with Autism Spectrum Disorder: A Pilot Study |
| 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 |
naimakhot02@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
MAHARASHTRA
410210
India |
| Phone |
9082194223 |
| Fax |
|
| Email |
drsatishpimpale@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Third Floor, Department of Neuro Physiotherapy, Tilak
Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar- 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
Third Floor, Department of Neuro Physiotherapy, Tilak
Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, 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 |
09405009315
naimakhot02@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 manipulation skills using Lego blocks |
Lego based exercises for hand manipulation skills in children with Autism Spectrum Disorder
The protocol will be given for 45 minutes per session, 3 days a week for 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
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
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment In-Hand Manipulation |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
21/03/2026 |
| 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="0"
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 is a pilot study exploring the preliminary effect of Lego based therapy 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. 10 children with Autism Spectrum Disorder between 6 to 12 years will be recruited for the study. All the children will undergo Lego based therapy protocol for 45 minutes per session, 3 days a week for 4 weeks. |