| CTRI Number |
CTRI/2024/09/074410 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Finemotor Training] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Fine motor skill training helps in improving legibility of handwriting |
|
Scientific Title of Study
|
Effectiveness of fine-motor skills training in improving handwriting skills in
children with illegible handwriting |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajkumar |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics
Chettinad Hospital and Research Institute
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
rajasonofgaja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujatha Sridharan |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics
Chettinad Hospital and Research Institute
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9282176464 |
| Fax |
|
| Email |
sridharansujatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujatha Sridharan |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics
Chettinad Hospital and Research Institute
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9282176464 |
| Fax |
|
| Email |
sridharansujatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural support from Chettinad Hospital and research institute,Chettinad Health City, SH 49A, Kelambakkam, Tamil Nadu 603103 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sujathasridharan |
Chettinad Hospital and Research Institute |
Department of Paediatrics
Chettinad Hospital and Research Institute.Rajiv Gandhi Salai, Kelambakkam, Kancheepurum, tamilnadu
Kancheepuram
TAMIL NADU |
9842176464
sridharansujatha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committe for student researche (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
handwriting problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fine Motor Training |
Children with poor handwriting are given Fine-motor training training will be given for 24 weeks (6 months) |
| Comparator Agent |
Handwriting training |
Children with poor handwriting are given handwriting training in handwriting note Training will be given for 24 weeks (6 months) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: Children with illegible handwriting
Exclusion criteria: Children with neurological disorders |
|
| ExclusionCriteria |
| Details |
Children with Neurological deficit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| legibility of handwriting using scoring system |
legibility of handwriting at baseline(0 months) and after 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement Academic performance |
6 months-1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Boys and Girls from 2nd to 7th standard will be included. They will be screened for illegibility of Handwriting using Handwriting proficiency screening questionnaire. The children with illegible handwriting will be included after getting informed consent from parents. Computer generated randomization will be done. Students will be randomized to Fine-motor training group and handwriting training group. They will be followed after 6 months of training. The improvement in legibility of handwriting will be observed. Details will be included in structured proforma. Data will be analyzed using unpaired t test. 26.03.2025 The recruitment has been done and started on Finemotor training |