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CTRI Number  CTRI/2024/04/065989 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of core stability exercises by using Swiss ball on belly and back muscles to help kids with Down syndrome to improve balance. 
Scientific Title of Study   Effect of core stability exercises by using Swiss ball on balance and core muscle strength in children with  down syndrome 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuj Lahoti 
Designation  Post Graduate Student 
Affiliation  Dr. D Y Patil College of Physiotherapy 
Address  Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor, Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  7028645898  
Fax    
Email  plahotianuj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidhi Shah 
Designation  Assistant Professor 
Affiliation  Dr. D Y Patil College of Physiotherapy 
Address  Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor, Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  8149383518  
Fax    
Email  vidhivarun13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidhi Shah 
Designation  Assistant Professor 
Affiliation  Dr. D Y Patil College of Physiotherapy 
Address  Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor, Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.


MAHARASHTRA
411018
India 
Phone  8149383518  
Fax    
Email  vidhivarun13@gmail.com  
 
Source of Monetary or Material Support  
Dr.D Y Patil college of physiotherapy OPD, Sant Tukaram Nagar, Pimpri, Pune Maharashtra 411018  
 
Primary Sponsor  
Name  Anuj Lahoti 
Address  Tower-1,1103, Mahindra Centralis, Pimpri, Pune,India 411018 
Type of Sponsor  Other [self] 
 
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 
Anuj Lahoti  Dr. D Y Patil college of physiotherapy OPD  Ground Floor, 1rt room, Pediatric department, Dr. D Y Patil college of physiotherapy OPD, Sant Tukaram Nagar, Pimpri, Pune Maharashtra 411018
Pune
MAHARASHTRA 		 7028645898

plahotianuj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D.Y. Patil Vidyapeeth  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 
Intervention  Core exercise on Swiss ball   Core exercise on Swiss ball will be given for total of 5 weeks for 3 days in a week for 30 minutes in each session. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age group between 8-12years
Pediatric balance scale score 21- 40.
Children with IQ more than 50-70.8
Willing participants
 
 
ExclusionCriteria 
Details  Children who had any recent cardiac comorbidity, subluxation of the upper and lower limbs and any visual and hearing deficits.
A history of orthopedic surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Core strength by using Pressure Biofeedback Unit   One, pre-data will be collected and then final post-intervention readings will be taken after 5 week completion.
 
 
Secondary Outcome  
Outcome  TimePoints 
Standing Stork Test  One, pre-data will be collected & then final post-intervention readings will be taken after 5-week completion. 
Timed up & go test  One, pre-data will be collected & then final post-intervention readings will be taken after 5-week completion. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

AIM:

To determine the effectiveness of core stability exercises by using Swiss ball on balance and core strength of children with Down syndrome

NEED FOR STUDY-

Swiss ball can be a valuable tool for enhancing core stability exercises. The unstable surfaces of a Swiss ball challenges balance and stability, forcing core muscles to engage more effectively to maintain the posture during exercises. Moreover, training on the uneven surface of a Swiss ball causes the trunk muscles to lengthen and shorten simultaneously in response to gravity, facilitating lateral flexors and trunk rotators and improving trunk control.

Thus, this study proposes to find the effect of Swiss ball exercise to improve core stability and its ultimate effect on balance in children with Down syndrome.

METHODOLOGY-

The screening of the participants will be done according to inclusion criteria and then the selected participants will be given 15 session of intervention programme of  core stability exercises by using swiss ball ( 3 times a week). then at the end of 15 session   the final post intervention data will be collected to see the difference or improvement in balance and core strength of children with Down syndrome.
 
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