| CTRI Number |
CTRI/2026/02/103448 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multisensory activities] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Improve Handwriting Skills in Children Using Activities that engage Multiple Senses |
|
Scientific Title of Study
|
Effectiveness of using multisensory activities on handwriting skills among children with dysgraphia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lekha S |
| Designation |
UG Student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT Pediatric division,Ward number 24, Department of Occupational Therapy, Chettinad General Hospital,Chettinad Health City,Rajiv gandhi salai(OMR),Kelambakkam ,Chennai ,Tamilnadu,India
Chennai
TAMIL NADU
603103
India |
| Phone |
7200277326 |
| Fax |
|
| Email |
lekha152005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lekha S |
| Designation |
UG Student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT Pediatric division,Ward number 24, Department of Occupational Therapy, Chettinad General Hospital,Chettinad Health City,Rajiv gandhi salai(OMR),Kelambakkam ,Chennai ,Tamilnadu,India
Chennai
TAMIL NADU
603103
India |
| Phone |
7200277326 |
| Fax |
|
| Email |
lekha152005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lekha S |
| Designation |
UG Student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT Pediatric division,Ward number 24, Department of Occupational Therapy, Chettinad General Hospital,Chettinad Health City,Rajiv gandhi salai(OMR),Kelambakkam ,Chennai ,Tamilnadu,India
Chennai
TAMIL NADU
603103
India |
| Phone |
7200277326 |
| Fax |
|
| Email |
lekha152005@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Pediatric division,Ward Number 24,Department of Occupational Therapy,Chettinad General Hospital,Chettinad Health City,Rajiv Gandhi Salai, Kelambakkam,Chennai,Tamilnadu,India,603103 |
|
|
Primary Sponsor
|
| Name |
Lekha S |
| Address |
OT Pediatric division,Ward Number 24,Department of Occupational Therapy,Chettinad General Hospital,Chettinad Health City,Rajiv Gandhi Salai, Kelambakkam,Chennai,Tamilnadu, India,603103 |
| Type of Sponsor |
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 |
| Dr Vignesh N |
Chettinad General Hospital |
OT Pediatric division,Ward number 24, Department of Occupational Therapy, Chettinad General Hospital,Chettinad Health City,Rajiv gandhi salai(OMR),Kelambakkam ,Chennai ,Tamil Nadu,India
Chennai
TAMIL NADU |
9750122121
n.vignesh789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F818||Other developmental disorders of scholastic skills, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Handwriting Proficiency Screening Questionnaire |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
| Intervention |
Multisensory activities |
Before enrolling each participant in the study, informed consent will be obtained from the parents or legal guardians, along with assent from the children, using consent forms approved by the Institutional Ethics Committee of Chettinad Health and Research Institute.A total of 50 children aged 7 to 14 years, diagnosed with dysgraphia (specific learning disorder – written expression), will be recruited from the Child Rehabilitation Centre, inclusive schools, and the Occupational Therapy Department of Chettinad Health and Research Institute. Eligibility will be confirmed through initial screening based on DSM-5 diagnostic criteria. After obtaining informed consent and confirming eligibility, participants will be randomly allocated into two groups—an experimental group and a control group—with 25 participants in each group, following a randomized controlled trial design. Baseline (pre-intervention) assessment of handwriting skills will be conducted for all participants using the
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with dysgraphia based on DSM-5 criteria.Children whose parents or guardians provide informed consent.Children willing to participate and attend intervention sessions regularly. |
|
| ExclusionCriteria |
| Details |
Children diagnosed with other neurodevelopmental disorders such as ADHD, Autism Spectrum disorder or Intellectual disability.Children with neurological, orthopedic,or visual impairments affecting handwriting.Children or parents/guardians unwilling to participate or refusing consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Handwriting Proficiency Screening Questionnaire(HPSQ) |
Handwriting skills will be assessed using the Handwriting Proficiency Screening Questionnaire(HPSQ) Before the intervention(Pre-intervention) and reassessed after four weeks of Multisensory activities intervention(Post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 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, parallel-group, active-controlled trial designed to evaluate the effectiveness of multisensory activities on handwriting skills among children with dysgraphia. A total of 50 children aged 7 to 14 years, diagnosed with dysgraphia, will be recruited from the Child Rehabilitation Centre, inclusive schools, and the Occupational Therapy Department of Chettinad Health and Research Institute. Informed consent will be obtained from parents or legal guardians, and assent will be obtained from the children prior to participation. Eligibility will be confirmed using DSM-5 diagnostic criteria and the Handwriting Proficiency Screening Questionnaire to identify handwriting difficulties. Participants will be randomly allocated into two groups, with 25 children in each group. The experimental group will receive a multisensory activities–based handwriting intervention, while the control group will receive routine occupational therapy for handwriting.The intervention will be administered for a total of 12 sessions, conducted three sessions per week, with each session lasting 45 minutes. Pre- and post-intervention assessments will be conducted using the Handwriting Proficiency Screening Questionnaire. The collected data will be statistically analyzed to determine the effectiveness of multisensory activities on handwriting skills among children with dysgraphia. |