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CTRI Number  CTRI/2025/12/099454 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparing rhythmic aerobic exercises and foot muscle exercises to improve balance and movement in children with Down syndrome having flat feet. 
Scientific Title of Study   Effectiveness of Rhythmic Aerobic Exercises versus Foot Muscle Exercises on balance and functional mobility in children with Down Syndrome exhibiting pes planus : A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadhana B Hathwar 
Designation  PG Student 
Affiliation  College of Physiotherapy , Dayananda Sagar University  
Address  Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.

Bangalore
KARNATAKA
562112
India 
Phone  6360496384  
Fax    
Email  sadhanahathwar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Bhat 
Designation  Assistant Professor  
Affiliation  College of Physiotherapy , Dayananda Sagar University  
Address  Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.

Bangalore
KARNATAKA
562112
India 
Phone  6364369412  
Fax    
Email  aditibhat1293@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Poojary 
Designation  Assistant Professor 
Affiliation  College of Physiotherapy , Dayananda Sagar University  
Address  Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt.

Bangalore
KARNATAKA
562112
India 
Phone  9108169985  
Fax    
Email  gayathri.poojary.jp@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  College of Physiotherapy, Dayananda Sagar University  
Address  Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt. – 562 112 
Type of Sponsor  Other [Private university ] 
 
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 Aditi Bhat  College of Physiotherapy , Dayananda Sagar University   Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dt. – 562 112
Bangalore
KARNATAKA 		 63643 69412

aditibhat1293@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
College of Physiotherapy, Dayananda Sagar University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Foot Muscle Exercises  Children in Group B will receive Foot Muscle Exercises for 30 minutes per session, 3 sessions per week, for 8 weeks. Exercises include toe curls, marble pickups with foot , short-foot exercise, ball roll, heel raises, and one-leg balance tasks- step-up and Foot ball kick. The intensity progresses from 3 repetitions (weeks 1–2), to 5 (weeks 3–4), 7 (weeks 5–6), and 10 repetitions (weeks 7–8). Conventional physiotherapy exercises for about 30 min (warm-up, balance training activities, cool-down) will also be provided to all participants along with Foot Muscle Exercises . 
Intervention  Rhythmic Aerobic Exercises   Children will receive Rhythmic Aerobic Exercises for 30 minutes per session, 3 sessions per week, for 8 weeks. The exercises include running in place, side-stepping, walking while eating, and turning in place, all performed with rhythmic auditory stimulation (8–16 beats/min). The intervention aims to improve balance, coordination, and functional mobility. Conventional physiotherapy exercises for about 30min (warm-up, balance training activities, cool-down) will also be provided to all participants along with Rhythmic Aerobic Exercises. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  a)Clinically diagnosed with Down Syndrome
b)Children whose parents provides informed consent
c)Children who are capable of understanding simple commands.IQ – 50-69 ( Stanford-Binet Intelligence Scale)
d)Ability to stand and ambulate independently without assistive devices.
 
 
ExclusionCriteria 
Details  a)Children with auditory and visual impairments
b)Children with other comorbidities such as cardiovascular issues, pulmonary impairments
c)Children with recent lower limb injury.
d)Children with history of lower limb orthopedic / corrective surgeries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pediatric Balance Scale (PBS)  Base line assessment and 8th week assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Time up and Go test  Base line assessment and 8th week assessment 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   30/12/2025 
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="6"
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 study aims to compare the effectiveness of Rhythmic Aerobic Exercises and Foot Muscle Exercises on balance and functional mobility in children with Down Syndrome having flexible pes planus, Down Syndrome is associated with hypotonia, ligamentous laxity, and delayed motor coordination, which contribute to poor balance and unstable gait. Pes planus affects the alignment of the foot and further increases the risk of balance deficits. Rhythmic aerobic exercises use music-based movement patterns to enhance motor control, whereas foot muscle exercises target the intrinsic and extrinsic foot muscles for improving the stability of the arch and enhancing functional alignment. Twenty eight children, aged between seven and fifteen years will be randomly allocated into two groups Group A receiving Rhythmic Aerobic Exercises and Group B receiving Foot Muscle Exercises. In addition, both groups will receive conventional physiotherapy. The outcomes will be measured using the Pediatric Balance Scale Timed Up and Go Test and Foot Posture Index before and after eight weeks of intervention. The study aims to determine which intervention provides greater improvement in balance and mobility. 
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