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CTRI Number  CTRI/2025/02/080334 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of Aerobic exercise on balance in children with Attention deficit hyperactive disorder 
Scientific Title of Study   Effect of Aerobic exercise on balance in children with Attention deficit hyperactive 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  Megha Trivedi  
Designation  MPT Student 
Affiliation  Nanavati Max Super specialty Hospital, 
Address  Department of Physiotherapy, ground floor, Nanavati Max Super specialty Hospital, SV road, Vile Parle west

Mumbai
MAHARASHTRA
400056
India 
Phone  9373491375  
Fax    
Email  meghatrivedi7788@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailja Mehta  
Designation  Assistant Professor- Physiotherapist 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia school of science, Department of physiotherapy, 7th floor Mithibai college building, Bhaktivedanta road, Vile parle west

Mumbai
MAHARASHTRA
400056
India 
Phone  9825382610  
Fax    
Email  shailja.mehta@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shailja Mehta  
Designation  Assistant Professor- Physiotherapist 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia school of science, Department of physiotherapy, 7th floor Mithibai college building, Bhaktivedanta road, Vile parle west

Mumbai
MAHARASHTRA
400056
India 
Phone  9825382610  
Fax    
Email  shailja.mehta@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, ground floor, Nanavati Max Super specialty hospital, SV road, Vile parle west, Mumbai 400056 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [NA ] 
 
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 
Dr Shailja Mehta  Nanavati Max Super Specialty Hospital   Ground floor - gym room, Department of Physiotherapy,Nanavati Max Super Speciality Hospital, SV road, Vile parle west
Mumbai
MAHARASHTRA 
9825382610

shailja.mehta@nmims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanavati Max Super Speciality Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic Exercise   it is a 6-week intervention with total 18 sessions per week (alternate days) 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Clinically diagnosed children with Attention Deficit Hyperactive Disorder  
 
ExclusionCriteria 
Details  any other neurological disorder.
any history of recent fracture.
any recent history of surgery.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Pediatric Berg Balance Scale.   Baseline & Post-intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Y balance test, Timed Floor to Stand Test  Baseline & Post-intervention  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   24/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/02/2025 
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)   Open to Recruitment 
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  

TITLE: Effect of Aerobic Exercise on Balance in Children with Attention Deficit Hyperactive Disorder.  

INTRODUCTION: Studies suggest that children with ADHD have significantly less balance control than other peers. Balance is one of the basic important principles of learning in children and its disorder can negatively affect learning, hence there is a need to improve balance in children with ADHD. Aerobic exercises have shown great results in improving balance, in cases such as diabetic neuropathy and osteoporosis. Studies also suggest that short term aerobic exercise interventions had a positive effect on attention, hyperactivity, impulsivity, anxiety, executive function, and social disorders of ADHD children.

RATIONALE: Children with Attention Deficit Hyperactivity Disorder (ADHD) often exhibit motor coordination difficulties, including impaired balance, which can affect their daily activities and overall physical performance. Aerobic exercise has been shown to stimulate the cerebellum and basal ganglia, key brain regions involved in motor coordination and postural control. Additionally, it increases levels of neurotransmitters such as dopamine and norepinephrine, which are often dysregulated in ADHD and enhance motor planning, proprioception, and postural stability. Thus, incorporating aerobic exercise into rehabilitation for children with ADHD may provide a non-pharmacological approach to improving balance.

AIM: To assess the Effect of Aerobic exercise on balance in children with Attention Deficit Hyperactive Disorder.

OBJECTIVE:

1.     To assess the Effect of Aerobic exercise on balance in children with Attention Deficit Hyperactive Disorder using Pediatric Berg Balance Scale.

2.     To assess the Effect of Aerobic exercise on balance in children with Attention Deficit Hyperactive Disorder using Time floor to sit Test.

3.     To assess the Effect of Aerobic exercise on balance in children with Attention Deficit Hyperactive Disorder using Y- Balance Test.

 

OUTCOME MEASURES: 1) Pediatric berg balance scale, 2) Y balance test and 3) Timed Floor to Stand test.

PROTOCOL: Frequency 3 days per week for 6 weeks, total 18 sessions.

Warm up exercises- Neck rotations, Arm circles, Trunk rotations, Spot marching and Heel to butt.

       Aerobic protocol –

Session 1-3 : Heel digs, Step touch, V box, Hamstring curl and Diagonal toe touch.

Session 4-6 : Heel touch – toe touch, Slide, Diamond, Knee lift, Jazz walk.

Session 7-9: Half Jack, 1-2-3 Tap, Double V box, Flick Kick, Slide step. 

Session 10 -12: Lunge, Diagonal toe touch, Hamstring curl, Diamond and Slide.

Session 13-15: Knee lift, V box jump back, Step touch, Jazz walk and Heel touch – toe touch.

Session 16-18: Grapevine, Half jack, Walk & Kick, Diamond, Hamstring Curl.

        Cool down exercises: Shoulder stretch, Triceps stretch, Toe touch and Child pose.

 
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