| CTRI Number |
CTRI/2025/09/094802 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to see if square stepping exercises can improve balance and walking in older adults Trial |
|
Scientific Title of Study
|
Efficacy of Square Stepping Exercises on Balance, Gait Speed and Fear of Fall in Frail Individuals : A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Kanda |
| Designation |
MPT Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi Amar Jyoti Institute of Physiotherapy, Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi East DELHI 110092 India |
| Phone |
9818968927 |
| Fax |
|
| Email |
kandaaman13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Mansi Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg, Delhi
East DELHI 110092 India |
| Phone |
8860028510 |
| Fax |
|
| Email |
mansi.mittal.pt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aman Kanda |
| Designation |
MPT Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy, Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi Amar Jyoti Institute of Physiotherapy, Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi East DELHI 110092 India |
| Phone |
9818968927 |
| Fax |
|
| Email |
kandaaman13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy, Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi |
|
|
Primary Sponsor
|
| Name |
Aman Kanda |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg, Delhi |
| 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 AMAN KANDA |
AMAR JYOTI HOSPITAL |
Neurology Research laboratory, third floor, Karkardooma, Vikas Marg, Delhi 110092 East DELHI |
9818968927
kandaaman13@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 (AJIRB-EC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FRAIL ELDERLY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONVENTIONAL BALANCE TRAINING EXERCISES |
A structured program designed to improve an individuals balance and stability, typically involving exercises that challenge both static and dynamic postures. These exercises are often performed on stable surfaces and can include activities such as standing on one leg, heel-to-toe walking, weight shifting, and sitting-to-standing movements. Conventional balance training aims to enhance coordination, proprioception, and gait, thereby reducing the risk of falls, particularly in older adults and those with frailty. It usually follows a routine progression, increasing in difficulty as the individual’s balance improves.
3 TIMES A WEEK FOR 4 WEEKS |
| Comparator Agent |
CONVENTIONAL BALANCE TRAINING EXERCISES |
A structured program designed to improve an individuals balance and stability, typically involving exercises that challenge both static and dynamic postures. These exercises are often performed on stable surfaces and can include activities such as standing on one leg, heel-to-toe walking, weight shifting, and sitting-to-standing movements. Conventional balance training aims to enhance coordination, proprioception, and gait, thereby reducing the risk of falls, particularly in older adults and those with frailty. It usually follows a routine progression, increasing in difficulty as the individual’s balance improves.
3 TIMES A WEEK FOR 4 WEEKS |
| Intervention |
SQUARE STEPPING EXERCISES |
Square Stepping Exercise (SSE) involves multidirectional step patterns on a gridded mat, making it a simple, adaptable, and low-cost intervention. It improves balance and reactive control, enhances proprioception, strengthens gait speed and stability, and reduces fear of falling. The cognitive challenge of remembering step sequences further stimulates executive function, while its group-based format promotes motivation and social engagement. The integration of cognitive and motor demands in SSE has been shown to stimulate neuroplasticity and enhance sensorimotor integration, potentially offering superior benefits in improving reactive balance, gait speed and reduces fear of fall.
3 TIMES A WEEK FOR 4 WEEKS |
| Comparator Agent |
SQUARE STEPPING EXERCISES |
Square Stepping Exercise (SSE) involves multidirectional step patterns on a gridded mat, making it a simple, adaptable, and low-cost intervention. It improves balance and reactive control, enhances proprioception, strengthens gait speed and stability, and reduces fear of falling. The cognitive challenge of remembering step sequences further stimulates executive function, while its group-based format promotes motivation and social engagement. The integration of cognitive and motor demands in SSE has been shown to stimulate neuroplasticity and enhance sensorimotor integration, potentially offering superior benefits in improving reactive balance, gait speed and reduces fear of fall.
3 TIMES A WEEK FOR 4 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age 60 to 85 years
Informed consent
Hindi Mental State Examination (HMSE) more than or equal to 21
Fried Frailty Score more than or equal to 3
Tinetti Performance Oriented Mobility Assessment (POMA) more than or equal to 19 |
|
| ExclusionCriteria |
| Details |
Engaged in regular exercise in past 3 months
Severe musculoskeletal, neurological, or cardiovascular disorders interfering with balance or safe exercise |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini Best
|
BASELINE AND 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fall efficacy scale |
BASELINE AND 4 WEEKS |
| 4 meters gait speed |
BASELINE AND 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
10/10/2025 |
| 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="11" 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
|
Subjects will be recruited through personal communication after screening. A verbal and written informed consent process will be followed. Through clinical postings at Amar Jyoti Rehabilitation and Research centre, Karkardooma, Delhi. Subjects will be recruited through screening. Assess is through institutional referral and voluntary participation. |