| CTRI Number |
CTRI/2025/04/085944 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of perturbation-based balance training on balance and gait in older adults. |
|
Scientific Title of Study
|
Effect of Perturbation-based Balance Training on Balance and Gait in Older Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja A Birje |
| Designation |
Post-graduate Student |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
PG 1 Classroom, Second floor, Department of Neurological and Psychosomatic Disorders, College of Physiotherapy, Sumandeep
Vidyapeeth deemed to be university at and post
pipariya taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
8431840916 |
| Fax |
|
| Email |
rutubirje14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
Cabin no. 3, Staffroom, ground floor Department of Pediatrics
College of Physiotherapy Sumandeep
Vidyapeeth deemed to be university at and post
pipariya taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
Cabin no. 3, Staffroom, ground floor Department of Pediatrics
College of Physiotherapy Sumandeep
Vidyapeeth deemed to be university at and post
pipariya taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Ground floor College of Physiotherapy Sumandeep Vidyapeeth deemed to be University Pipariya taluka Waghodia Vadodara Gujarat 391760 India |
|
|
Primary Sponsor
|
| Name |
Rutuja A Birje |
| Address |
PG 1 Classroom Ground floor
Department of Neurological and Psychosomatic Disorders College of Physiotherapy Sumandeep
Vidyapeeth an institution deemed to be University at and post Pipariya taluka Waghodia Vadodara Gujarat 391760 India |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Rutuja A Birje |
Dhiraj General Hospital |
Near and around the campus of Sumandeep Vidyapeeth deemed to be University Pipariya taluka Waghodia Road Vadodara Gujarat 391760 India
Vadodara
GUJARAT |
8431840916
rutubirje14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
older adults 60 years and above
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling older adults
Able to do sit to stand with or without support.
Able to walk independently 10 meters with or without walking aid.
|
|
| ExclusionCriteria |
| Details |
Individuals with Mini Mental Scale Examination less than or equal 24
Any neuromusculoskeletal conditions or surgeries that affects balance and gait
Any uncorrected visual impairments, undergoing current chemotherapy, severe vertigo, deformities or any cognitive impairments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Brief-BEST test |
Will be assessed at the baseline and at the end of sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Fall Efficacy Scale [MFES]
30 second chair stand test |
Will be assessed at the baseline & at the end of sixth week |
|
|
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)
|
01/05/2025 |
| 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 Yet Recruiting |
| 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 evaluate the balance and gait of older adults in community settings. Participants will be screened based on inclusion and exclusion criteria, and given an informed consent form and participant information sheet. A detailed assessment will be conducted, and pre-intervention outcome measures will be taken. Participants will be divided into two groups using alternate method: Control/Conventional Group (A) and Perturbation based Balance Training (PBT) Group (B). The intervention will last for 18 sessions, with each group having a different protocol.
Duration of intervention for both the groups: 45-50 mins session/day for 3 days/week for 6 weeks i.e. 18 sessions.
Protocol will be given for 45-50 minutes per day with 1-2 minutes break during each exercise.
In the Control Group, participants will perform exercises according to their tolerance level, starting with 3 repetitions per exercise. The program includes stretching lower extremities, single leg stance, lateral stepping, mini lunges, tandem and Romberg stance, marching in place, step-ups, sit to stand, gait training, and tandem and side walking. In the PBT Group, participants will perform circuit training with unstable devices (BOSU ball, balance cushions, and foam mattress), including standing on both feet, single leg stance, lateral stepping, mini lunges, step-ups, heel and toe raise, marching, and supported squats. Trainers will supervise individual training intensities and progression.
After six weeks of intervention, MFES, 30-Second Chair Stand Test, and Brief-BESTest scores will be noted and compared to pre-intervention values. |