| CTRI Number |
CTRI/2025/07/091112 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| 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
|
Study on balance exercises to prevent falls in elderly living in hospitals and in the community |
|
Scientific Title of Study
|
Effectiveness of Balance Training Exercises in Institutional Dwelling Vs Community Dwelling in improving balance and fall risk in elderly people :A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revati Prakash Kulkarni |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
MGM Institute Of Physiotherapy dept of community physiotherapy opd
MGM Hospital campus,N-6 Cidco aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9021376887 |
| Fax |
|
| Email |
revatikulkarni53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDoss Prakash Sudharanjan |
| Designation |
Professor and HOD Department of Community Physiotherapy, MGMIOP. |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Mahatma Gandhi Mission Medical College and Hospital, MGM Campus,N-6 Cidco.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9886386726 |
| Fax |
|
| Email |
dossprakashs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDoss Prakash Sudharanjan |
| Designation |
Professor and HOD Department of Community Physiotherapy, MGMIOP |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Mahatma Gandhi Mission Medical College and Hospital, MGM Campus,N-6 Cidco.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9886386726 |
| Fax |
|
| Email |
dossprakashs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Revati Prakash Kulkarni |
| Address |
MY WORLD Infront of airport, A4,602,Chhatrapati Sambhajinagar(Aurangabad). |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| revati kulkarni |
Balasaheb Thakre Botanical Garden |
N8 Cidco Yashashri Colony Aurangabad
Aurangabad
MAHARASHTRA |
9021376887
revatikulkarni53@gmail.com |
| revati kulkarni |
MGM medical college and hospital. |
MGM Institute of Physiotherapy, dept of community physiotherapy OPD N6 CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA |
9021376887
revatikulkarni53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe For Research On Human Subjects MGM campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
geriatric population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A:Balance master exercises(institutionalized dwelling). |
the balance master consists of balance board,2 footplates,a tilting sensor,a computer system and a display screen(which visualizes the input data).the individual participating will have to stand on balance trainer and place the foot on v shaped marker made.for balance training following exercises or games will be included on balance trainer:
the chase-use your baalnce to perform a wide selection of differnt patterns such as forward,backwards,leftwards,rightwards to keep the red marker inside the provided circle
the maze-use the balance to guide the man out of several different mazes to finally reach the desired destination.
the stepper-move your weught to differnt corners of plat form.sometimes leaning will not be enough
the static pattern-use your balance to guide the man through different patterns. Remember to stay on the course.
|
| Comparator Agent |
Group B :On the Move Exercises(in community dwelling) |
The on the move (OTM exercise program) consists of-
the warm up exercises,
stepping and walking exercises,
balance exercises,
cool down exercises.
The warm up exercises consists of gentle stretches and mobility exercises.
Stepping patterns consists of-
Stepping forward,
alternate side of stepping,
stepping forward and backward,
alternate right and left steps,
patterns such as making ovals, spirals, serpentines that are progressed by changing amplitude of patterns, altering speed of walking.
balance exercises-tandem walking, one leg stand, one left stand with reach forward.
The stepping and walking patterns were designed to promote the appropriate timing and co-ordination of stepping during walking by enhancing proper weight shifting during stepping, coordinating activation between hip abductors and adductors to facilitate the load/unload mechanism, and by practicing coordination of legs and trunk during walking.
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 65 to 80 years
2. Able to walk without mobility aids in their home.
4.Both male and female
6. Elder persons interested in preserving and improving balance
|
|
| ExclusionCriteria |
| Details |
1. Severe vision impairments
2. Diagnosed vestibular problems
3. Any acute medical conditions not stable.
4. Presence of a neuromuscular disorders.
5. Presence of any lower extremity musculoskeletal disorder.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short Physical Performance Battery Test(SPPB) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mini-best test(mini balance evaluation systems test) |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
16/08/2025 |
| 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="1"
Days="12" |
|
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 aims to compare the effectiveness of balance training exercises in improving balance and reducing fall risk among elderly people living in institution and those living in the community. The study will be conducted over 6 weeks with total of 58 participants from geriatric population in Aurangabad India. Institutional dwelling group will receive balance master exercise program and the community dwelling program will receive on the move exercise program. Both groups will receive a structured balance training program and the results will be compared to see which setting shows better improvement.
proposed outcome-
Balance training done in an institution or in the community will make a difference in improving balance and reducing the chance of falls in elderly people OR
Where the balance training is done (institution or community) will not make any difference in improving balance or reducing falls in elderly people
|