| CTRI Number |
CTRI/2025/07/090653 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OCCUPATIONAL THERAPY] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Using Picture Activities Helps Children with Intellectual Disabilities in Daily Life and Well-Being." |
|
Scientific Title of Study
|
EFFECTIVENESS OF VISUAL SEQUENCING ACTIVITIES ON OCCUPATIONAL PERFORMANCE AND QUALITY OF LIFE AMONG CHILDREN WITH INTELLECTUAL DISABILITY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Selvendhiran S |
| Designation |
PG Student |
| Affiliation |
Chettinad Academy of Research and Education (Deemed to be University) |
| Address |
OT- Pediatric Division, Ward No: 24, Department of Occupational Therapy, Chettinad General hospital,
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam, TN .
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9080337123 |
| Fax |
|
| Email |
selvendhiransenthil1719@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Bhuvaneshwari S |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Academy of Research and Education (Deemed to be University) |
| Address |
OT- Pediatric Division, Ward No: 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City.
Rajiv Gandhi Salai,
Kelambakkam, TN.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Selvendhiran S |
| Designation |
PG Student |
| Affiliation |
Chettinad Academy of Research and Education (Deemed to be University) |
| Address |
OT- Pediatric Division, Ward No: 24, Department of Occupational Therapy,
Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam, TN.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9080337123 |
| Fax |
|
| Email |
selvendhiransenthil1419@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Selvendhiran S |
| Address |
Chettinad Health City
Rajiv Gandhi Salai (OMR)
Kelambakkam, TN 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 |
| Selvendhiran S |
Chettinad General Hospital |
OT - Pediatric Division, Ward No:24, Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam, TN.
Kancheepuram
TAMIL NADU |
9080337123
selvendhiransenthil1719@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education (Deemed to be University) Institutional Human Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Visual Sequencing Activities |
Intervention protocols:
Name: Visual Sequencing Activities Program
Duration: 6–8 weeks
Frequency: 2 sessions per week
Session Length: 45 - 60 minutes
Facilitator: Paediatric occupational therapist
Format: One-on-one therapy sessions
Materials Used:
Visual schedules (picture cards, task strips)
Sequence charts (step-by-step activity boards)
Real-life objects for daily living tasks
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Borderline and Mild Intellectual disability children were included.
2)Children aged between 7 to 12 years were included. 3)Written consent by one parent indicating their
agreement to participate in the study. |
|
| ExclusionCriteria |
| Details |
1)Children with severe visual impairment, orthopedic problems with upper limb and speech communication disorder were excluded.
2)Children with other psychiatric problems.
3)Children with medical disorder affecting movements were excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Canadian Occupational Performance Measure (COPM)
2. Pediatric Quality of Life (PQoL)
|
2 months(8- Weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="0"
Months="2"
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 is a randomized, parallel-group, active-control trial conducted over eight weeks at Chettinad Hospital and Research Institute. Participants are randomized to receive structured visual sequencing activities (intervention group) . The primary outcome measures are: -
Occupational performance, assessed using the Canadian Occupational Performance Measure (COPM) -
Quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) Both outcomes will be evaluated at baseline (pre-test) and at the end of the intervention (post-test) to determine the intervention’s impact. |