| CTRI Number |
CTRI/2025/11/096901 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Combined Training Of Balance And Mental Functions As Compared To Mental Function Training alone On Mental Functions And Behavioural problems In Children With ADHD |
|
Scientific Title of Study
|
Dual-Task Training Of Balance And Cognition As Compared To Cognitive Training On Cognitive And Behavioural Symptoms In Children With ADHD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Awatramani |
| Designation |
PG student |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
School Of Physiotherapy, 6th Floor, School of Medicine Building, Plot No-2. Sector -5, Nerul, Navi Mumbai- 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9930173422 |
| Fax |
|
| Email |
priyankaawatramani15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amruta Nerurkar |
| Designation |
Professor |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
School Of Physiotherapy, 6th Floor, School of Medicine Building, Plot No-2. Sector -5, Nerul, Navi Mumbai- 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9967910372 |
| Fax |
|
| Email |
amruta.nerurkar@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Amruta Nerurkar |
| Designation |
Professor |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
6th Floor, Plot No2. Sector 5, Nerul, Navi Mumbai 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9967910372 |
| Fax |
|
| Email |
amruta.nerurkar@dypatil.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
6th Floor, Plot No 2 Sector 5, Nerul, Navi Mumbai 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Priyanka Awatramani |
DY Patil Hospital and Research Centre |
3rd Floor,Multi-speciality Physiotherapy OPD, Plot No-2. Sector -5, Nerul, Navi Mumbai- 400706 Thane MAHARASHTRA |
09930173422
priyankaawatramani15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee For Biomedical And Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, (2) ICD-10 Condition: F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type, (3) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cognitive Training |
45 mins of performing a series of cognitive Tasks |
| Intervention |
Dual Task Training |
15 mins to maintain Positions challenging Balance while performing cognitive Tasks and 30 mins of performing only cognitive tasks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 6-12 years
ADHD diagnosed formally using the DSM V criteria and confirmed by either a pediatrician or a psychologist or a psychiatrist
Participants must have stable behavioral and medication management for at least three months prior to enrollment to minimize confounding effects from recent treatment changes
Consenting Parents
|
|
| ExclusionCriteria |
| Details |
Children who are unable to follow instructions.
Children with any other medical (physical or psychological) conditions, such as epilepsy, cardiovascular issues, or orthopaedic injuries
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PEBL Test Battery – A standardized computerized tool measuring
Vanderbilt |
Baseline, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
14/11/2025 |
| 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="5" 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
|
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders affecting children worldwide with symptoms that extend beyond inattention and impulsivity. Increasing evidence shows the children with ADHD virtual experience difficulties with balance coordination and sensory integration due to changes in the dopaminergic and vestibular systems. Neuroimaging studies have revealed alterations in the cerebellum caudate nucleus and basal ganglia-areas vital for motor control and postural stability. Studies show that 30 to 50% of children with ADHD exhibit poor balance and coordination with vestibular dysfunction present approximately 60% of the combined type of ADHD. Deficits not only compromise motor performance but may also exacerbate attention and executive control problems. Despite this, physiotherapeutic interventions targeting balance in children with ADHD remain limited. Considering the neuroplasticity of the developing brain, dual task training that combines balance and cognitive components may represent a potential non-pharmacological approach to influence postural stability attention and behavioural regulation in children with ADHD. It is possible that engaging both motor and cognitive systems simultaneously could promote better functional outcomes. Investigating the effective of structured dual task training may therefore offer valuable insights into its probable role as a holistic neuro rehabilitation intervention potentially bridging the gap between motor rehabilitation, cognitive enhancement, and behavioural modulation in children with ADHD. |