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CTRI Number  CTRI/2025/12/099437 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 06/03/2026
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   Effect of Weighted pen and hand exercises on handwriting in children with autism 
Scientific Title of Study   Effectiveness of Fine Motor Protocol using a weighted Pen on Handwriting Proficiency in Autism Spectrum Disorder Using Handwriting Legibility Scale: 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  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

Raigarh
MAHARASHTRA
410210
India 
Phone  9082023434  
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

Raigarh
MAHARASHTRA
410210
India 
Phone  9867631730  
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

Raigarh
MAHARASHTRA
410210
India 
Phone  9867631730  
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, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai 
 
Primary Sponsor  
Name  TMVs Lokmanya Tilak College of Physiotherapy 
Address  Plot No. 3, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai - 410210. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
TMVs Lokmanya Tilak College of Physiotherapy  Plot No. 3, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai - 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 Shweta Solanke  TMVs Lokmanya Tilak College Of Phsiotherpy  TMVs Lokmanya tilak college Of Physiotherapy, Third floor Department Of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 		 9004599638

shweta.solanke6662@ gmail.com 
 
Details of Ethics Committee
Modification(s)  
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fine Motor Protocol using Weighted Pen  Children will receive a structured fine motor training protocol combined with the use of a weighted pen during handwriting activities. The protocol includes hand strengthening exercises (therapy putty, sponge squeezing, clothespin pinch, rubber band finger extension), finger dexterity and coordination activities (finger-to-thumb opposition, bead stringing, tweezers activities, coin manipulation), in-hand manipulation exercises (rolling small balls, marble pick-up, page turning), and sensory feedback with positive reinforcement. Writing tasks will be performed using a weighted pen to enhance proprioceptive input and grip stability. The intervention will be given three sessions per week for six weeks, with each session lasting 30–40 minutes. 
Comparator Agent  Standardized Physiotherapy Treatment with weighted pen   Children will receive standardized physiotherapy treatment focusing on general fine motor and upper limb activities. This includes stretching and range of motion exercises for wrist and fingers, general hand strengthening using therapy putty and hand grips, proprioceptive activities such as weight-bearing on hands and use of weighted balls, gross motor coordination tasks like throwing and catching, and basic unstructured handwriting practice using a weighted pen. The intervention will be provided three sessions per week for six weeks, with each session lasting 15–20 minutes. 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged 8-14 years diagnosed with ASD
Mild to moderate Autistic children
Handwriting legibility scale Level poor to mild moderate
Able to follow simple verbal command
Ability to hold a pencil and Write alphabets
Hyposensitive to touch and pressure using sensory profile scale 2
Consent from parents/guardians. 
 
ExclusionCriteria 
Details  Comorbidities affecting motor function (e.g., cerebral palsy, muscular dystrophy)
Severe sensory deficits like blindness or deafness.
Hyper tactile and hypersensitive to proprioception
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Handwriting legibility evaluation: - Handwriting legibility scale (HLS)  Baseline (Pre intervention) then Mid Intervention and after 6 weeks of intervention (Post Intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Hand Grip Strength and pinch strength assessment   Baseline (Pre intervention) then Mid Intervention and after 6 weeks of intervention (Post Intervention) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   27/12/2025 
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   Children with autism spectrum disorder often face difficulties with fine motor skills, which affect their handwriting ability and overall academic performance. Poor handwriting can reduce classroom participation and lead to frustration. A weighted pen is designed to provide extra sensory feedback that helps improve control and pencil pressure. However, there is limited research on the use of weighted pens for children with autism. This study aims to evaluate the effectiveness of combining fine motor skill training with the use of a weighted pen to improve handwriting proficiency in children aged 8 to 14 years. This age group is important because of higher brain plasticity, which supports better response to motor and sensory training. The findings will help develop evidence based strategies to enhance handwriting skills and academic success in children with autism. 
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