| CTRI Number |
CTRI/2025/08/093482 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Boosting Balance and Core Strength in Obese Individuals Using BOSU and Therapy Ball Exercises |
|
Scientific Title of Study
|
Effects of BOSU Exercises and Therapeutic Ball Exercises to Improve Balance and Core Control in Obese Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu Raj Singh |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeswar Institute of Physiotherapy and Rehabilitation |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University), Mullana Ambala HARYANA
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9430493888 |
| Fax |
|
| Email |
singhrituraj656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeswar Institute of Physiotherapy and Rehabilitation |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar(Deemed tobe University), Mullana Ambala ,HARYANA.
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeswar Institute of Physiotherapy and Rehabilitation |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar(Deemed tobe University), Mullana Ambala ,HARYANA.
Ambala
HARYANA
133207
India
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Physiotherapyand Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute ofPhysiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University),Mullana-Ambala, Haryana, 133207 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunita Sharma |
Maharishi Markandeshwar deemed to be university, mullana, ambala, Haryana,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Raj Singh |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation , |
First Floor, Physiotherapy Department, MMIPR,Maharishi Markandeshwar(Deemed to be University),Mullana Ambala HARYANA
Ambala
HARYANA
Ambala
HARYANA |
09430493888
singhrituraj656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Maharishi Markandeshwar Institute of Medical scienceand Research,Mullana-Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese Grade 1 and 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BOSU Ball Exercises
Therapeutic Ball Exercises |
Different Type of Exercises With BOSU Ball and Therapeutic Ball 3 Sessions per week for 4 Weeks |
| Comparator Agent |
placebo |
just warmup,relaxation and stretching for 3 days per Week for 4 Weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with obesity, classified as Grade 1(BMI 30-34.9) Grade 2(BMI 35-39.9)
OA knee patients LBA patients Diabetes PCOD
Hypothyroidism
Age- 18 to 35 years
Patient willing to participate
|
|
| ExclusionCriteria |
| Details |
Severe Obesity
Neurological condition impairing Balance
No history of recent major surgeries or musculoskeletal injuries
Cardiovascular Respiratory Conditions
Neurological Disorders
Post menopausal &Pregnant women
Recent Surgery &Trauma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
TUG Test
Plank test
Sit up Test |
Baseline ,Post 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF36 |
Baseline ,post 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="1"
Months="0"
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 aims to evaluate the effects of BOSU ball exercises and therapeutic (Swiss) ball exercises on improving balance and core control in obese patients. Participants with a BMI greater or equal to 30 will be randomly assigned to two intervention groups. One group will perform balance and core strengthening exercises using a BOSU ball and a therapeutic ball while the control goup of placebo will perform some stretching and warm up exercises. The intervention will be conducted over a period of 4weeks. Standardized outcome measures will be used to assess changes in balance and core control before and after the intervention. The study seeks to determine the effective approach for enhancing postural stability and core muscle function in obese individuals and to support evidence-based physiotherapy interventions for this population. |