| CTRI Number |
CTRI/2025/10/096096 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Neuromotor task training for children with attention deficit hyperactivity disorder. |
|
Scientific Title of Study
|
Effectiveness of exergaming and neuromotor task training on cognitive, coordination and anxiety in 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 |
CARLIN JERSHA RACHEL J |
| Designation |
Assistant Professor |
| Affiliation |
Dr. M.G.R. Edcucational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai-77.
Chennai TAMIL NADU 600077 India |
| Phone |
09176345400 |
| Fax |
|
| Email |
carlinjersharachel@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr CV Senthil Nathan |
| Designation |
Principal |
| Affiliation |
Dr. M.G.R. Edcucational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai-77.
Chennai TAMIL NADU 600077 India |
| Phone |
9841236943 |
| Fax |
|
| Email |
principal.physio@drmgrdu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr CV Senthil Nathan |
| Designation |
Principal |
| Affiliation |
Dr. M.G.R. Edcucational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai-77.
Chennai TAMIL NADU 600077 India |
| Phone |
9841236943 |
| Fax |
|
| Email |
principal.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, chennai-600077 |
|
|
Primary Sponsor
|
| Name |
CARLIN JERSHA RACHEL J |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, chennai-600077 |
| 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 |
| CARLIN JERSHA RACHEL J |
Physiotherapy Out Patient Department, A.C.S. Medical College and Hospital |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai-77. Chennai TAMIL NADU |
09176345400
carlinjersharachel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional training |
Conventional training - 3 sessions per week for 30 mins for 12 weeks |
| Intervention |
Exergaming |
Exergaming - 3 sessions per week for 30 mins for 12 weeks |
| Intervention |
Neuromotor Task Training |
Neuromotor Task Training - 3 sessions per week for 30 mins for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants should have the ability to tolerate to do the exercise.
Participants should have a sufficient level of communication, whether verbal or non-verbal, to understand instructions and respond during the training exercises.
Participants must be ambulatory and able to walk independently.
|
|
| ExclusionCriteria |
| Details |
Children with history of musculoskeletal, other neurological disorders or cardiovasulaar conditions,
Hearing and vision impairments,
Known genetic disorder,
Previous surgical history or head injury, Recent fractures,
Tic disorder, tremors, seizures and wheezing,
Parents self reported mental illness.
Autism spectrum disorder, cerebral palsy or other physical disabilities.
Individuals taking medictaions. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of Exergame and Neuromotor Task Training on cognition, coordination, and anxiety in children with Attention Deficit Hyperactivity Disorder (ADHD). |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To decrease impulsive responses by enhancing self-regulation skills through structured Exergaming activities.
To reduce hyperactive behaviors by improving motor planning and control through Neuromotor Task Training.
To strengthen executive functioning skills, such as working memory and task switching, through interactive Exergaming and neuromotor-based tasks. |
12 weeks, 3 sessions per week for 30 mins.
|
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
25/10/2025 |
| 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="1" Months="3" 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 experimental study aims to evaluate the effectiveness of Exergaming and Neuromotor Task Training in improving cognition, motor coordination, and reducing anxiety in children with Attention Deficit Hyperactivity Disorder (ADHD). A total of 120 children will be screened and randomly assigned to one of three groups: Exergame (Group A), Neuromotor Task Training (Group B), and Control (Conventional Therapy, Group C). The study will be conducted at the Physiotherapy Outpatient Department, Dr. M.G.R. Educational and Research Institute. Pre- and post-intervention assessments will be done using CAB-ADHD (CogniFit) for cognition, BOT-2 for motor proficiency, and SCAS-PRS for anxiety. The goal is to determine whether these non-pharmacological approaches can serve as effective complementary therapies for children with ADHD. |