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CTRI Number  CTRI/2025/02/080274 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [OCCUPATIONAL THERAPY]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Square-Stepping Exercise in Children with Down Syndrome 
Scientific Title of Study   Effects of Square-Stepping Exercise on Balance 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  Saumya Garg 
Designation  Postgraduate student (Master in Occupational Therapy) 
Affiliation  Indian Spinal Injuries Center- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Center, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector-C, Vasant kunj, South west Delhi

South West
DELHI
110070
India 
Phone  9354800374  
Fax    
Email  saumyagarg79@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saumya Garg 
Designation  Postgraduate student (Master in Occupational Therapy) 
Affiliation  Indian Spinal Injuries Center- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Center, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector-C, Vasant kunj, South west Delhi


DELHI
110070
India 
Phone  9354800374  
Fax    
Email  saumyagarg79@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Lipika Malik 
Designation  Assistant Professor 
Affiliation  Indian Spinal Injuries Center- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Center, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector-C, Vasant kunj, South Delhi

South West
DELHI
110070
India 
Phone  9999931199  
Fax    
Email  lipika.otist@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, IAA Colony, Sector-C, Vasant Kunj, New Delhi, Delhi-110070 
 
Primary Sponsor  
Name  NA 
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 Lipika Malik  UDAI working together works  B3/39, Janakpuri, New Delhi Ground Floor, Room no. 1
South West
DELHI 
9999931199

lipika.otist@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE INDIAN SPINAL INJURIES CENTER  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  Regular Occupational Therapy  Participants will take regular occupational therapy for 3 times a week over a course of 6 weeks 
Intervention  Square-Stepping Exercise  Square-Stepping Exercise will be given on a fine mat for 3 sessions per week over a course of 6 weeks. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Diagnosis of Down Syndrome, able to stand and walk independently, able to follow and understand simple instructions, mild intellectual disability with IQ level (50-70), parents who give consent to participate 
 
ExclusionCriteria 
Details  Any other diagnosed medical condition such as autism, cerebral palsy, fragile X syndrome, vision and hearing loss, children who were unable to stand unsupported 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pediatric Balance Scale   At baseline and after 6 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   21/02/2025 
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  
Down syndrome is a genetic disorder caused by an additional copy of chromosome 21, which results in 47 chromosomes instead of 46. When it comes to everyday activities and overall quality of life, children with Down syndrome may experience delays in their motor development, as well as challenges in learning to balance and initiate movements. Square-stepping exercise (SSE) involves a series of movement patterns such as forward, backward, lateral, and oblique stepping. It is easy-to-follow, structured balancing protocol. Square-stepping exercise program has also been used in intervention for children with autism spectrum disorder and studies have shown that this protocol effectively enhances balance in the kindergarten-aged children. In this study, the participants will be taken from Occupational therapy centres and Learning schools of Delhi NCR. Participants will be selected on the basis of inclusion criteria. Study design will be experimental and total sample size is 20. Participants will then be divided into two groups (Group - A and Group -B). i.e. 10 participants in each group. Group -A will receive regular occupational therapy and Square-stepping exercise program and Group – B will receive regular occupational therapy. The training programme will be given for 30 minutes, 3 times a week for 6 weeks.
 
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