| CTRI Number |
CTRI/2025/04/084223 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING SQUARE STEPPING EXERCISES AND BRAIN GYM EXERCISES TO IMPROVE BALANCE AND COGNITION AMONG CHILDREN WITH DOWN SYNDROME |
|
Scientific Title of Study
|
COMPARISON OF SQUARE STEPPING EXERCISES AND BRAIN GYM EXERCISES IN IMPROVING BALANCE AND COGNITION AMONG 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 |
THOTA PARIMALA GRACE |
| Designation |
MASTER OF PHYSIOTHERAPY |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, NEURO-OUT PATIENT DEPARTMENT, GROUND FLOOR, EXERCISE THERAPY ROOM
Hyderabad
TELANGANA
500044
India |
| Phone |
6281348938 |
| Fax |
|
| Email |
gracethotaparimala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS. A. DURGA REDDY |
| Designation |
PROFESSOR (DEPARTMENT OF NEUROLOGY) |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, NEURO-OUT PATIENT DEPARTMENT, GROUND FLOOR, EXERCISE THERAPY ROOM
Hyderabad
TELANGANA
500044
India |
| Phone |
9492925784 |
| Fax |
|
| Email |
abbadidurga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
THOTA PARIMALA GRACE |
| Designation |
PG-STUDENT-MASTER OF PHYSIOTHERAPY-NEUROSCIENCES |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, NEURO-OUT PATIENT DEPARTMENT, GROUND FLOOR, EXERCISE THERAPY ROOM
Hyderabad
TELANGANA
500044
India |
| Phone |
6281348938 |
| Fax |
|
| Email |
gracethotaparimala@gmail.com |
|
|
Source of Monetary or Material Support
|
| DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY (DDCOP), DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE (DDHRC), DURGABAI DESHMUKH VOCATIONAL TRAINING AND REHABILITATION CENTRE (DDVTRC) |
|
|
Primary Sponsor
|
| Name |
THOTA PARIMALA GRACE |
| Address |
DURGABHAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, OSMANIA UNIVERSITY, ADIKMET, 500044 |
| Type of Sponsor |
Other [SELF SPONSOR] |
|
|
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 |
| MSTHOTA PARIMALA GRACE |
DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE, DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
DURGABHAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, NEURO-OUT PATIENT DEPRTMENT, GROUND FLOOR, EXERCISE THERAPY ROOM
Hyderabad
TELANGANA |
06281348938
gracethotaparimala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE |
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 |
BRAIN GYM EXERCISES |
BRAIN GYM EXERCISES - CROSS CRAWL, BELLY BREATHING, BRAIN BUTTONS, POSITIVE POINTS, THINKING X, LAZY EIGHTS, ENERGIZER, ENERGY YAWNS, THINKING CAPS, ELEPHANT +CONVENTIONAL BALANCE TRAINING |
| Intervention |
SQUARE STEPPING EXERCISES |
SQUARE STEPPING EXERCISES - ELEMENTARY PATTERN 1 AND 2+ CONVENTIONAL BALANCE TRAINING
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. CHILDREN WITH DOWN SYNDROME
2. AGE - 6-14 YEARS
3. ALL GENDERS WHO MEET INCLUSION CRITERIA
4. CHILDREN WITH MODERATE IQ ( IQ: 35 TO 50)
5. MONTREAL COGNITIVE ASSESSMENT SCORE (MOCA) - GREATER THAN 24
6. TIMED UP AND GO TEST (TUG) SCORE - LESS THAN 20 SECONDS
7. PEDIATRIC BERG BALANCE SCORE (BBS) - GREATER THAN 40 |
|
| ExclusionCriteria |
| Details |
1. HISTORY OF ANY CONGENITAL HEART DEFECTS AND ORTHOPEDIC SURGERY IN THE PAST 1 YEAR
2. HAVING ANY OTHER ASSOCIATED NEUROLOGICAL AND MOBILITY DISORDER, SEIZURES
3. SEVERE MENTAL RETARDATION
4. ASSOCIATED VISUAL AND AUDITORY PROBLEMS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BALANCE - TIMED UP AND GO TEST AND PEDIATRIC BERG BALANCE SCALE |
BASELINE AND AFTER 8 WEEKS OF POST INTERVENTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COGNITIVE FUNCTION - MONTREAL COGNITIVE ASSESSMENT SCALE |
BASELINE AND AFTER 8 WEEKS OF POST-INTERVENTION |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/04/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 (DS), is one of the most common chromosomal disorder in pediatrics which is caused by the presence of complete or a part of third copy of chromosome 21.Because of chromosomal abnormality and structural differences in the Brain-reduction in volume children with Down Syndrome have balance and cognitive Issues. Literature also shows improvement in Balance and Cognitive function with use of rehabilitation protocols like Square Stepping Exercises (SSE) and Brain Gym Exercises (BGE). By incorporating these exercises into the daily routine of children with Down Syndrome (DS), we can create a structured and consistent approach to their physical and cognitive development which may show positive outcomes in terms of both Balance and Cognition. Previous studies on Square Stepping Exercises and Brain Gym Exercises in Geriatric populations and in patients with Diabetic neuropathy respectively showed significant improvement in balance, cognition and reduced the risk of falls. The purpose of this study is to determine the effectiveness of Square Stepping Exercises (SSE) and Brain Gym Exercises (BGE) over one another in improving balance and cognitive function among children with Down Syndrome. The aim of this study is to compare the effectiveness of Square Stepping Exercises and Brain Gym Exercises over one another in improving balance and cognitive function among children with Down Syndrome. |