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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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