| CTRI Number |
CTRI/2025/07/091776 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of exercises to reduce falls and improve balance in older adults: A comparison of square stepping and agility drills |
|
Scientific Title of Study
|
Comparison of Agility Drill Training and Square Stepping Exercise to reduce Fear of Fall and improve Balance in Older Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MQ/09/2022-2023 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safiya Yasmeen |
| Designation |
Postgraduate Student- MPT |
| Affiliation |
Durgabai Deshmukh College of Physiotherapy |
| Address |
Durgabai Deshmukh College of Physiotherapy, Andhra Mahila Sabha, Vidya Nagar, Osmania University Road
Hyderabad
TELANGANA
500044
India |
| Phone |
9701488712 |
| Fax |
040-27667889 |
| Email |
safiyahussain456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Safiya Yasmeen |
| Designation |
Postgraduate Student- MPT |
| Affiliation |
Durgabai Deshmukh College of Physiotherapy |
| Address |
Durgabai Deshmukh College of Physiotherapy, Andhra Mahila Sabha, Vidya Nagar, Osmania University Road
Hyderabad
TELANGANA
500044
India |
| Phone |
9701488712 |
| Fax |
040-27667889 |
| Email |
safiyahussain456@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Safiya Yasmeen |
| Designation |
Postgraduate Student- MPT |
| Affiliation |
Durgabai Deshmukh College of Physiotherapy |
| Address |
Durgabai Deshmukh College of Physiotherapy, Andhra Mahila Sabha, Vidya Nagar, Osmania University Road
Hyderabad
TELANGANA
500044
India |
| Phone |
9701488712 |
| Fax |
040-27667889 |
| Email |
safiyahussain456@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fatima Old Age Home- Falaknuma Railway Station Rd, Yadgiri Nagar, Falaknuma, Hyderabad, Telangana 500053 |
|
|
Primary Sponsor
|
| Name |
Durgabai Deshmukh College of Physiotherapy |
| Address |
Andhra Mahila Sabha, Vidya Nagar, Osmania University Road, Hyderabad- 500044, Telangana |
| Type of Sponsor |
Other [Physiotherapy Educational Institution] |
|
|
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 |
| MD Wasif |
Fatima Old Age Home |
Falaknuma Railway Station Rd, Yadgiri Nagar, Falaknuma, Hyderabad, Telangana 500053
Hyderabad
TELANGANA |
7660954936
fatimaoldagehome@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R262||Difficulty in walking, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Agility Drill Training (ADT) |
Participants will perform Agility Drill Training for 30 minutes per session followed by proper warm up and cool down, 3 times per week for 8 weeks. Training includes cone drills, ladder drills, zig-zag runs, directional changes, and dynamic balance tasks. Exercises will be progressed in difficulty weekly. All sessions will be conducted under supervision. |
| Intervention |
Square Stepping Exercise (SSE) |
Participants will perform Square Stepping Exercise (SSE) for 30 minutes per session, followed by proper warm up and cool down, 3 times per week for 8 weeks. Exercises will be performed in standing position and participants will be taught both elementary and intermediate stepping patterns. These patterns will be progressively introduced over an 8-week period, with an increasing level of difficulty and the introduction of dual tasks to challenge both motor and cognitive functions. All sessions will be conducted under supervision. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Both genders were included.
Subjects aged 60-75 years (healthy young old age) with a Timed Up and Go (TUG) score greater than 10 seconds but less than 13 seconds. |
|
| ExclusionCriteria |
| Details |
Subjects associated with severe cognitive impairments, severe musculoskeletal conditions, or other neurological disorders such as traumatic brain injury, parkinsonism, labyrinthitis, stroke. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome 1:
Balance: Berg Balance Scale (BBS)
Primary Outcome 2:
Fear of Falling: Falls Efficacy Scale (FES) |
Balance: Berg Balance Scale (BBS)- Baseline and after 8 weeks of intervention.
Fear of Falling: Falls Efficacy Scale (FES)- Baseline and after 8 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome is being assessed in this study |
Not applicable |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="2"
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 study aims to compare the effectiveness of Agility Drill Training (ADT) and Square Stepping Exercise (SSE) in reducing fear of falling and improving balance in older adults aged 60 to 75 years. It is designed as a randomized prospective controlled clinical trial to be conducted at two old age homes in Hyderabad over a period of 8 weeks. Participants will be randomly assigned to either the SSE group or the ADT group. Balance and fear of falling will be assessed using the Berg Balance Scale (BBS) and Fall Efficacy Scale (FES) at baseline and after 8 weeks. The estimated total sample size is 50 participants. |