| CTRI Number |
CTRI/2026/01/102384 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Visual Praxis Based Occupational Therapy Program] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying whether occupational therapy activities that improve seeing and movement help children with reading difficulties live better and manage daily activities more easily |
|
Scientific Title of Study
|
Effectiveness of a Visual Praxis–Based Occupational Therapy Program on Quality of Life in Children with Developmental Dyslexia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanimozhi M |
| Designation |
UG student |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9342803063 |
| Fax |
|
| Email |
kanimozhe07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneshwari S |
| Designation |
Assistant professor |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
OT - Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kanimozhi M |
| Designation |
UG student |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
OT - Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9342803063 |
| Fax |
|
| Email |
kanimozhe07@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT - Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103 |
|
|
Primary Sponsor
|
| Name |
Kanimozhi M |
| Address |
OT - Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, 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 Bhuvaneshwari S |
Chettinad General Hospital |
OT - Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU |
9342803063
kanimozhe07@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: F810||Specific reading disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pediatric Quality of Life Inventory (PedsQL) |
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 |
Visual Praxis Based Occupational Therapy Program |
This study adopts an experimental research design to evaluate the effectiveness of a Visual Praxis–Based Occupational Therapy Program on the quality of life of children with developmental dyslexia. Ethical approval will be obtained from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE) prior to study initiation. Written informed consent will be secured from parents or legal guardians, along with assent from participating children, and all procedures will adhere to established ethical guidelines for research involving human participants. A total of 50 children diagnosed with developmental dyslexia will be screened and recruited. Participants aged 8–12 years will be selected from the Occupational Therapy Department of Chettinad Hospital and selected clinics in Kelambakkam, Chengalpattu District. Diagnosis and eligibility will be confirmed using DSM-5 criteria, and only those meeting the inclusion criteria will be enrolled. Eligible participants will be randomly assigned to either an intervention group (n = 25) or a control group (n = 25) to minimize selection bias and ensure group comparability. Baseline assessment of quality of life will be conducted for all participants using the Pediatric Quality of Life Inventory (PedsQL), which evaluates physical, emotional, social, and school functioning. The intervention group will receive a structured Visual Praxis–Based Occupational Therapy Program delivered by a qualified occupational therapist. The program will consist of 45-minute sessions, three times per week for four weeks, totaling 12 sessions. Therapy will be individualized and age-appropriate, focusing on visual discrimination, spatial relations, visual–motor integration, motor planning, and functional participation relevant to academic and daily living activities. The control group will receive no visual praxis–based intervention during the study period and will continue with routine activities or standard care. Post-intervention assessment using the PedsQL will be conducted for both groups. Pre- and post-intervention scores will be analyzed within and between groups using appropriate statistical methods to determine the program’s effectiveness in improving quality of life. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 8 and 12 years both male and female. Children diagnosed with developmental dyslexia according to DSM-5. Children who have poor quality of life, as identified by Pediatric Quality of Life Inventory (PedsQL). |
|
| ExclusionCriteria |
| Details |
Children below 5 years of age. Children diagnosed with neurological or developmental disorders other
than Developmental Disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pediatric Quality of Life Inventory (PedsQL) |
Quality of life will be assessed using Pediatric Quality of Life Inventory (PedsQL) at baseline (pre-intervention), and reassessed after completion of four weeks of Visual Praxis Based Occupational Therapy Program (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)
|
03/02/2026 |
| 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 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 adopts an experimental research design to evaluate the effectiveness of a Visual Praxis–Based Occupational Therapy Program on the quality of life of children with developmental dyslexia. Ethical approval will be obtained from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE) prior to study initiation. Written informed consent will be secured from parents or legal guardians, along with assent from participating children, and all procedures will adhere to established ethical guidelines for research involving human participants. A total of 50 children diagnosed with developmental dyslexia will be screened and recruited. Participants aged 8–12 years will be selected from the Occupational Therapy Department of Chettinad Hospital and selected clinics in Kelambakkam, Chengalpattu District. Diagnosis and eligibility will be confirmed using DSM-5 criteria, and only those meeting the inclusion criteria will be enrolled. Eligible participants will be randomly assigned to either an intervention group (n = 25) or a control group (n = 25) to minimize selection bias and ensure group comparability. Baseline assessment of quality of life will be conducted for all participants using the Pediatric Quality of Life Inventory (PedsQL), which evaluates physical, emotional, social, and school functioning. The intervention group will receive a structured Visual Praxis–Based Occupational Therapy Program delivered by a qualified occupational therapist. The program will consist of 45-minute sessions, three times per week for four weeks, totaling 12 sessions. Therapy will be individualized and age-appropriate, focusing on visual discrimination, spatial relations, visual–motor integration, motor planning, and functional participation relevant to academic and daily living activities. The control group will receive no visual praxis–based intervention during the study period and will continue with routine activities or standard care. Post-intervention assessment using the PedsQL will be conducted for both groups. Pre- and post-intervention scores will be analyzed within and between groups using appropriate statistical methods to determine the program’s effectiveness in improving quality of life. |