| CTRI Number |
CTRI/2025/10/096309 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Of Task Specific Training For ADHD Children. |
|
Scientific Title of Study
|
A Comparative Analysis Of Pertubation Based Training, Task Specific Training and Convential Training On Balance, Gait and Muscle power in Children With Attention Deficit Huperactivity 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 |
Dr Saravanan V |
| Designation |
Lecturer |
| Affiliation |
Dr. M.G.R. Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai.
Chennai TAMIL NADU 600077 India |
| Phone |
7299608887 |
| Fax |
|
| Email |
saravanansiva1103@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Mohan Kumar G |
| Designation |
Professor |
| Affiliation |
Dr. M.G.R. Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai.
Chennai TAMIL NADU 600077 India |
| Phone |
9791072249 |
| Fax |
|
| Email |
mohankumar.physio@drmgrdu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohan Kumar G |
| Designation |
Professor |
| Affiliation |
Dr. M.G.R. Educational and Research Institute |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, Chennai.
Chennai TAMIL NADU 600077 India |
| Phone |
9791072249 |
| Fax |
|
| Email |
mohankumar.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saravanan V |
| Address |
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute, INDIA, TAMIL NADU, 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 |
| Dr Saravanan V |
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 |
7299608887
saravanansiva1103@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 session per week for 30 mins for 12 weeks |
| Intervention |
Perturbation Based Training |
Perturbation Based Training - 3 session per week for 30 mins for 12 weeks |
| Intervention |
Task Specific Training |
Task Specific Training - 3 session per week for 30 mins for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Iq level of 80.
Participants have a sufficient level of communication both verbal and non verbal.
Participants must be ambulatory.
Diagnosed with adhd according to medical report
|
|
| ExclusionCriteria |
| Details |
Impaired hearing and vision
Child with cerebral palsy
Any neurological conditions.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the effect of Perturbation training, task specific training on gait, balance and selective muscle power in children with Attention Deficit Hyperactivity Disorder for 8 weeks |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce hyperactive behaviour by Task Specific Training.
To improve coordination & balance through Perturbation Based Training.
To strengthen the lower limb & functioning skills & task switching through interactive Perturbation Based Training & Task Specific Training for 8 weeks. |
1 |
|
|
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)
|
28/10/2025 |
| 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="2" 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 Perturbation Based Training and Task Specific Training in improving
the gait, balance and muscle power in children with Attention Deficit
Hyperactivity Disorder (ADHD).A total of 120 children will be screened and
randomly assigned to one of three groups : Perturbation Based Training (Group A), Task Specific
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 Euleria
Riablo for gait, Balance accessor for
balance, and Push pull dynamometer for
muscle power. The goal is to determine whether these non-pharmacological
approaches can serve as effective complementary therapies for children with ADHD.
|