| CTRI Number |
CTRI/2026/01/101870 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Task-Oriented training combined with Therapy Ball] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to Study on Improving Attention in Children with Attention and Hyperactivity Difficulties Using Simple Tasks and Therapy Ball Exercises |
|
Scientific Title of Study
|
Effect of Task-Oriented training combined with Therapy ball on Attention among Children with Attention Deficit Hyperactivity Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Keren Daphne Samuel |
| Designation |
UG Student |
| Affiliation |
Chettinad School Of Occupational Therapy Kelambakkam |
| Address |
OT Paediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
09176763379 |
| Fax |
|
| Email |
kerensamuel3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vignesh N |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad School Of Occupational Therapy Kelambakkam |
| Address |
OT Paediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
975012212 |
| Fax |
|
| Email |
n.vignesh789@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh N |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad School Of Occupational Therapy Kelambakkam |
| Address |
OT Paediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
975012212 |
| Fax |
|
| Email |
n.vignesh789@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
R Keren Daphne Samuel |
| Address |
OT Paediatric 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 Vignesh N |
Chettinad General Hospital |
OT Paediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
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: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NICHQ Vanderbilt Assessment Scale. |
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 |
Task-Oriented training combined with therapy ball |
Before initiating the study, written informed consent will be obtained from all participants after
thoroughly explaining the aim, procedures, potential risks, and benefits of the research.
Following consent, all participants will undergo a pre-test assessment to establish baseline data.
Once the pre-test data has been collected, participants will be randomly allocated into two
groups: the Experimental Group and the Control Group. The Experimental Group will receive a
structured intervention as per the designed intervention protocol for a period of four weeks,
while the Control Group will not receive any intervention by researcher during this time. The
experimental group will be given intervention by the researcher and care giver will be trained.
Subject will perform activities under supervision of caregiver. Follow-up of intervention will be
done by researcher using suitable mode of connect eg: Phone call, visits, whatsapp call etc..
After the completion of the intervention period, a post-test assessment will be conducted for
both groups using the same evaluation tools as the pre-test. The data obtained from the pre
and post-tests will be subjected to statistical analysis to determine the effectiveness of the
intervention. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Individual diagnosed with ADHD based on DSM-5 criteria. Age between 6 to 12 years |
|
| ExclusionCriteria |
| Details |
Other Neuro Psychiatric diagnoses or
coexisting physical and mental diagnoses with ADHD greater than 6 years or lesser than 12 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study outcome will be measured by using NICHQ Vanderbilt Assessment Scale. |
Attention will be assessed by using the NICHQ Vanderbilt Assessment Scale before the intervention and reassessed after four weeks of task-oriented training combined with therapy ball |
|
|
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
|
N/A |
|
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 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 Effect of Task-Oriented training combined with Therapy ball on Attention among
Children with Attention Deficit Hyperactivity Disorder A total of 50 participants aged 6 to 12 years, diagnosed with Attention Deficit Hyperactivity Disorder based on DSM-5 criteria will be recruited from the Department of Occupational Therapy, Chettinad Hospital and other Clinics from Chengalpattu District. Written informed consent will be obtained from Parent/legal guardian, prior to enrollment. Ethical approval for the study has been obtained from the Institutional Review Board of Chettinad University Hospital CHRI, CARE. Eligible participants will be randomly allocated into two groups: an intervention group n = 25 and a control group n = 25. Baseline assessment of attention will be conducted using the NICHQ Vanderbilt Assessment scale The intervention group will receive a Task-Oriented training combined with Therapy ball delivered for 45 minutes per session, three days per week, over a period of four weeks. The control group will receive no researcher-led intervention during the same period. At the end of the four-week intervention period, post-intervention assessments will be carried out using the same outcome measures. Pre- and post-intervention scores will be statistically analyzed to determine the effectiveness of the intervention in improving attention among children with ADHD |