| 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
|
|
|
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
|
|
|
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
|
|
|
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. |