| CTRI Number |
CTRI/2025/03/082727 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study looks at how making the belly and back stronger along with balance training using the BOBO balance system, can help older adults steps quicker and more safely with one group test to see is these exercises improve there reaction time when stepping . |
|
Scientific Title of Study
|
Effect of core stability and trunk exercises along with balance training using BOBO balance system on stepping reaction time in geriatric - single arm intervention study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Ravindra Jodangade |
| Designation |
Post - Graduate |
| Affiliation |
Datta Meghe College Of Physiotherapy |
| Address |
Department of Community Physiotherapy , Datta Meghe College Of Physiotherapy , shri Datta Meghe Polytechnic campus , Wanadongri , Hingna road , Nagpur , Maharashtra , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9503359987 |
| Fax |
|
| Email |
shweta16jodangade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Kahile |
| Designation |
Professor |
| Affiliation |
Datta Meghe College Of Physiotherapy |
| Address |
Department of Community Physiotherapy , Datta Meghe College Of Physiotherapy , shri Datta Meghe Polytechnic campus , Wanadongri , Hingna road , Nagpur , Maharashtra , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8698715695 |
| Fax |
|
| Email |
milind.sportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Ravindra Jodangade |
| Designation |
Post - Graduate |
| Affiliation |
Datta Meghe College Of Physiotherapy |
| Address |
Department of Community Physiotherapy , Datta Meghe College Of Physiotherapy , shri Datta Meghe Polytechnic campus , Wanadongri , Hingna road , Nagpur , Maharashtra , India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9503359987 |
| Fax |
|
| Email |
shweta16jodangade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College Of Physiotherapy , Wanadongri, Hingna road , Nagpur-441110, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College Of Physiotherapy |
| Address |
Wanadongri , Hingna Road , Nagpur 441110 Maharashtra , India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shweta Ravindra Jodangade |
Datta Meghe College Of Physiotherapy |
Community Physiotherapy OPD , Datta Meghe College Of Physiotherapy , shri Datta Meghe Polytechnic campus , Wanadongri , Hingna road , Nagpur ,441110, Maharashtra , India
Nagpur
MAHARASHTRA |
09503359987
shweta16jodangade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy , Nursing (APN) Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R296||Repeated falls, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
core stability and trunk exercises along with BOBO balance training |
The intervention spans eight weeks(24 sessions that is 3 days per week for 8 weeks), lasting 30 minutes per day. The exercise protocol is divided into three progressive levels. Level 1 includes abdominal hollowing, bridging, lower trunk rotation, single-leg bridges, crunches, and oblique crunches, each performed for hold of 5 seconds over 10 repetitions to a single participant. In Level 2, the intensity increases slightly, incorporating abdominal hollowing, bridging, lower trunk rotation, crunches, plank holds, and seated marching, with exercises performed for 5–10 seconds hold across 12 repetitions to each participants. Level 3 introduces further challenges with abdominal hollowing, bridging, lower trunk rotation, seated marching, and wall squats, each performed for 5 seconds holds over 15 repetitions. balance training with the BOBO Balance System is taken for 15 minutes per session for all 24 sessions at all levels. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Able to walk independently without any assistive device,
2.No vestibular and visual problems, nor cognitive impairment examined by physician or history
3. mini mental state examination score greater than 25
4.No recent history of any back abdominal and lower limb surgery
5.Subject BMI below 29.9
|
|
| ExclusionCriteria |
| Details |
1.Neurological defect (examples; stroke, traumatic brain injury, dementia or parkinson’s disease)
2.Musculoskeletal condition
3.cardiovascular problems (such as, unstable angina or uncontrolled hypertension)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Choice Stepping Reaction Time Test
2.Berg balance Scale |
Pre intervention and after 8 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. MMT of core & trunk
2. BOBO balance score |
Pre-intervention & after 8 weeks post-intervention |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
30/03/2025 |
| 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
|
The study investigates the impact of core stability and trunk exercises combined with BOBO balance training on stepping reaction time in geriatrics to reduce fall risk. With aging, muscle deterioration and sensory impairments contribute to balance issues, increasing fall-related injuries. This single-arm interventional study includes 39 participants (aged 60–75 years), undergoing an 8-week training program with balance and core exercises using the BOBO balance system. Key outcome measures include Choice Stepping Reaction Time (CSRT), Berg Balance Scale, and BOBO Balance System Score, The study aims to establish BOBO balance training as an effective intervention to enhance mobility, improve reaction time, and reduce fall risk in the elderly, promoting better quality of life.the data will be analysed using appropriate statistical test. |