| CTRI Number |
CTRI/2025/05/087850 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
How Square-Stepping Exercises Help Improve Balance, Quality of Life and Prevent Falls in Elderly at Home and in Institutions |
|
Scientific Title of Study
|
Effectiveness of square-stepping exercise on balance, fall and quality of life among community-dwelling vs institutionalized young old adults: an experimental 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 |
Vaishnavi Waghe |
| Designation |
Post-Graduate |
| Affiliation |
Datta Meghe College of Physiotherapy, Wanadongri, Hingna, Nagpur, Maharashtra, India |
| Address |
Datta Meghe College of Physiotherapy wanadongri , hingna road nagpur , India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020846588 |
| Fax |
|
| Email |
vaishnavi.waghe18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Kahile |
| Designation |
Professor |
| Affiliation |
Datta Meghe College of Physiotherapy, Wanadongri, Hingna, Nagpur, Maharashtra, India |
| Address |
Department of Community Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna, Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8698715695 |
| Fax |
|
| Email |
milind.sportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Waghe |
| Designation |
Post-Graduate |
| Affiliation |
Datta Meghe College of Physiotherapy, Wanadongri, Hingna, Nagpur, Maharashtra, India |
| Address |
Datta Meghe College of Physiotherapy, Wanadongri Nagpur India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020846588 |
| Fax |
|
| Email |
vaishnavi.waghe18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri, Hingna, Nagpur, 441110 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 Vaishnavi Waghe |
Community Out Patient Department, Datta Meghe College of Physiotherapy |
Room number 2, Ground floor, Community Department, Datta Meghe College of Physiotherapy, Wanadongri, Hingna, Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA |
7020846588
vaishnavi.waghe18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved Physiotherapy Nursing (APN) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Balance Issues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Square Stepping Exercise |
SSE is a 250 × 100cm mat with 40 squares (25 × 25 cm each) was used. Participants performed forward, backward, lateral, and oblique step patterns while walking on their toes to avoid tripping. The complexity of patterns increased gradually after a 1-week familiarization period. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who signed the written informed consent.
2. Both male and female.
3. Individual with age from 60 to 74 years (young-old adults)
4. Individual who are community-dwelling or institutionalized older
5. Participants who can ambulate independently or with minimal assistance (e.g., use of a cane)
6. GDS less than 5
|
|
| ExclusionCriteria |
| Details |
1. Participants currently undergoing intensive physiotherapy or structured balance training programs under another physiotherapy protocol
2. Un cooperative patients
3. Those who are registered in another clinical trial
4. GDS more than 5
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Balance – Timed Up and Go Test (TUG)
2. Fall Risk – Fall Efficacy Scale (FES-I)
3. Quality of Life (QoL) – WHOQOL-BREF |
pre-intervention 1st week
post-intervention 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/07/2025 |
| 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="6"
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 experimental study aimed to evaluate the effectiveness of Square-Stepping Exercise (SSE) in improving balance, reducing fall risk, and enhancing quality of life among community-dwelling and institutionalized young-old adults (aged 60–74). Falls are a significant concern among the elderly, especially due to associated morbidity, functional decline, and psychological impacts like fear of falling. The SSE program, involving progressive, cognitively demanding step patterns on a mat, is recognized for enhancing motor coordination, postural stability, and cognitive function. The study was conducted over 18 months using a comparative design, with 25 participants in each group receiving SSE interventions over two weeks. Outcome measures included the Timed Up and Go Test (TUG) for balance, Fall Efficacy Scale-International (FES-I) for fall risk, and WHOQOL-BREF for quality of life. The study utilized random sampling and various statistical tests (e.g., paired/unpaired t-tests, ANOVA) for data analysis. The results are expected to clarify whether SSE offers comparable or differential benefits in community versus institutional settings, thereby supporting tailored fall-prevention interventions for distinct elderly populations. |