| CTRI Number |
CTRI/2025/09/094440 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Balance in Children with Down Syndrome Using a Bosu Ball |
|
Scientific Title of Study
|
Effects of Balance Training with Bosu Ball in Children with Down Syndrome - A Case Series |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKANSHA SAROYA |
| Designation |
Master of Physiotherapy (Neurology) Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg,
Delhi, INDIA
East
DELHI
110092
India |
| Phone |
8076945141 |
| Fax |
|
| Email |
akanshasaroya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREKSHA SHARMA PT |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg,
Delhi, INDIA
East
DELHI
110092
India |
| Phone |
9990640376 |
| Fax |
|
| Email |
prekshas059@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKANSHA SAROYA |
| Designation |
Master of Physiotherapy (Neurology) Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg,
Delhi, INDIA
East
DELHI
110092
India |
| Phone |
8076945141 |
| Fax |
|
| Email |
akanshasaroya14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy
Karkardooma, Vikas Marg,
Delhi, INDIA 110092 |
|
|
Primary Sponsor
|
| Name |
AKANSHA SAROYA |
| Address |
Amar Jyoti Institute of Physiotherapy
Karkardooma, Vikas Marg,
Delhi, INDIA 110092 |
| Type of Sponsor |
Other [SELF] |
|
|
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 PREKSHA SHARMA PT |
Amar Jyoti Rehabilitation and Research Centre |
OPD, Physiotherapy Department
, Karkardooma, Vikas Marg,
Delhi, INDIA -110092
East
DELHI |
9990640376
prekshas059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institute of Physiotherapy Institutional Review Board- Ethical Committee |
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 |
| Intervention |
Balancing exercises on Bosu Ball |
Total Duration of intervention is three sessions a week for 4 weeks.
The exercises are as follows
1.In standing position, alternative ascent and descent from bosu ball.
2.Use same foot for ascending and descent.
3.Ascend and descend from right side and same from left side.
For above 3 exercises, hold of 10 sec and 3 repetitions.
4.Semi squatting on bosu ball with hold of 15 sec and 3 repetitions.
5.In standing, twist the trunk to left and from right also
2 sets and 4 repetitions with 10 sec hold.
6.In Prone lying, with hands behind the head, trunk extensions to be performed
3 sets and 3 repetitions with 10 sec hold.
7.Lunging on the bosu ball, while lifting the right leg and same to be done from left leg also
4 repetitions with 10 sec hold.
|
| Comparator Agent |
NOT APPLICABLE
|
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with medical diagnosis of Down syndrome
2.IQ 45 or above
3.A child capable of ambulating independently for a distance of one metre without the use of any assistive device.
4.BMI of Healthy weight category.
|
|
| ExclusionCriteria |
| Details |
1.Participants with any co-occurring neurological conditions—such as autism spectrum disorder (ASD), intellectual disability (ID), cerebral palsy, or seizure disorders.
2.Uncorrected disability in visual, auditory sensation and vestibular organ.
3.Any acute medical or surgical history.
4.Chronic pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PEDIATRIC BALANCE SCALE, TIMED UP AND GO TEST, ONE LEG STANDING TEST |
First week,
Fifth week,
Sixth week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GMFM-88 |
First week,
Fifth week,
Sixth week
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
27/09/2025 |
| 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="8"
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 is a case series with A B A design to assess the effects of balance training with Bosu Ball in children of age 7 to 15 years with Down Syndrome. Subjects will be assessed in three phases A, B, A. Initial A refers to baseline assessment Pretest, B refers to intervention Post test 1 & last A refers to withdrawal of treatment and then assessing it Post test 2. The time duration of phase A will be one week, for phase B will be four weeks, and last phase A will be of one week. Intervention will include Balance exercises on Bosu Ball, three sessions a week for 4 weeks. Primary outcome measures will include Pediatric Balance Scale, Timed Up and Go test, and One Leg Standing Test at first week, fifth week, and sixth week. The secondary outcome measures will include Gross motor function measure GMFM 88 at first week, fifth week, and sixth week. |