| CTRI Number |
CTRI/2026/03/105878 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a Weighted Pen On Handwriting Difficulties in Children with Autism |
|
Scientific Title of Study
|
Weighted Pen as an Assistive Tool for Handwriting Disability 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 |
Dr Shweta Solanke |
| Designation |
PG Student |
| Affiliation |
TMVs Lokmanya Tilak Physiotherapy College |
| Address |
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
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
410210
India |
| Phone |
09082023434 |
| Fax |
|
| Email |
shweta.solanke6662@ gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak Physiotherapy College |
| Address |
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
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
410210
India |
| Phone |
09867631730 |
| Fax |
|
| Email |
tkulkarni1110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak Physiotherapy College |
| Address |
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
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
410210
India |
| Phone |
09867631730 |
| Fax |
|
| Email |
tkulkarni1110@gmail.com |
|
|
Source of Monetary or Material Support
|
| 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 Maharashtra 410210
India |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherpy |
| Address |
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 Maharashtra 410210
India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherpy |
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 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Solanke |
TMVs Lokmanya Tilak College Of Phsiotherpy |
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 |
09082023434
shweta.solanke6662@ gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Weighted pen combined with fine motor protocol
|
A structured fine motor training program combined with handwriting practice using a weighted pen.
The weighted pen provides additional proprioceptive input and grip stability to improve fine motor control and handwriting performance in children with Autism Spectrum Disorder.
The intervention was administered for 6 weeks, 3 sessions per week, with each session lasting 45 minutes (30 minutes of fine motor activities and 15 minutes of handwriting practice using a weighted pen). |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 8 to 14 years diagnosed with mild to moderate Autism Spectrum Disorder identified using the Indian Scale for Assessment of Autism (ISAA), with handwriting difficulties and ability to follow simple verbal instructions
|
|
| ExclusionCriteria |
| Details |
Children with severe Autism Spectrum Disorder, presence of other neurological conditions, severe visual or hearing impairment, upper limb musculoskeletal deformities, or those who have received handwriting-specific intervention within the past three months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Handwriting Legibility Scale |
Baseline mid intervention after 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand Dynamometer & Pinchmeter |
Baseline Mid intervention & 6 weeks of intervention |
|
|
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)
|
25/03/2026 |
| 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="1"
Days="15" |
|
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
|
Children with Autism Spectrum Disorder often experience handwriting difficulties due to poor grip strength reduced fine motor control and impaired dexterity. These difficulties can affect academic performance classroom participation and independence in daily activities. Early low cost and practical assistive interventions are needed to address handwriting related disability in this population. This study aims to evaluate the effectiveness of a weighted pen combined with a structured fine motor protocol on handwriting proficiency grip strength and pinch strength in children with Autism Spectrum Disorder. The study is designed as a single arm quasi experimental pilot study conducted in a clinical and school based setting. A total of ten children aged eight to fourteen years diagnosed with mild to moderate Autism Spectrum Disorder were included. Participants received fine motor training along with handwriting practice using a weighted pen for six weeks with three sessions per week. Each session lasted forty five minutes. Handwriting proficiency was assessed using the Handwriting Legibility Scale while grip strength and pinch strength were measured using a hand dynamometer and pinch meter respectively. Assessments were performed at baseline and after completion of the intervention. The study aims to determine whether a weighted pen can serve as a simple assistive tool to improve handwriting related outcomes and support functional participation in children with Autism Spectrum Disorder |