| CTRI Number |
CTRI/2025/02/081476 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How foot and ankle exercises can help older adults improve their Balance |
|
Scientific Title of Study
|
Effect of Foot and Ankle Muscle strengthening on balance in geriatric population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krusha Patel |
| Designation |
MPT Student |
| Affiliation |
SVKMs NMIMS |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Max Superspeciality Hospital, S.V. Road, Vile Parle (W)
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
7226020523 |
| Fax |
|
| Email |
krushapatel18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailja Mehta |
| Designation |
Assistant Proffesor- Physiotherapist |
| Affiliation |
SVKMs NMIMS |
| Address |
Sunandan DIvatia School Of Science,Department of Physiotherapy, 7th Floor Mithibai college building, Bhaktivedanta Road, Vile Parle (W)
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9825382610 |
| Fax |
|
| Email |
shailja.mehta@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailja Mehta |
| Designation |
Assistant Proffesor- Physiotherapist |
| Affiliation |
SVKMs NMIMS |
| Address |
Sunandan DIvatia School Of Science,Department of Physiotherapy, 7th Floor Mithibai college building, Bhaktivedanta Road, Vile Parle (W)
MAHARASHTRA
400056
India |
| Phone |
9825382610 |
| Fax |
|
| Email |
shailja.mehta@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Ground Floor, Nanavati Max Superspeciality Hospital, SV. Road, Vileparle West, Mumbai-400056 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [None] |
|
|
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 Shailja Mehta |
Nanavati Max Superspeciality Hospital |
Department of Physiotherapy, Ground Floor, SV Road, Vile Parle West
Mumbai (Suburban)
MAHARASHTRA |
9825382610
shailja.mehta@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy geriatric population with mild to moderate risk of fall BBS- 21-56
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foot and ankle exercises
|
Foot and Ankle exercises to geriatric population
Training - for 4 weeks intervention with total 12 sessions - 3 sessions per week (alternate days) |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Mild to Moderate Risk Of Fall- BBS- 21-56
Not involved in any regular exercise programme |
|
| ExclusionCriteria |
| Details |
Elderly having any peripheral vascular disease or Deep vein Thrombosis
Any neurological disorder present
Any recent injuries to lower limbs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
|
Baseline and post 4 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Reach test |
Baseline and post 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
10/03/2025 |
| 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="6"
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
|
TITLE -Effect of foot and ankle exercises on Balance in Geriatric population: INTRODUCTION - Aging is a significant risk factor for morbidity, mortality and falls particularly among the elderly population in India, where life expectancy has increased. RATIONALE - Age related changes, including muscle weakness, reduced bone density (e.g. osteoporosis) and decreased joint mobility, contribute to impaired balance and heightened fall risk. Additionally, cognitive decline, proprioceptive changes and vestibular system degradation also affect an elderly person’s ability to maintain stability. Foot structural changes further exacerbate these balance issues. The elderly often experience difficulty in maintaining balance due to compromised sensory system, joint stiffness and muscle weakness, increasing fall susceptibility. Furthermore, the fear of falling leads to reduction in mobility and quality of life. Effective balance recovery strategies, such as ankle and hip strategies are critical for reducing falls and improving stability. Understanding these age-related changes is essential for developing interventions that enhance balance, reduce falls and improve the overall well-being of elderly individuals. AIM – The aim of this study was to determine whether strengthening of the foot and ankle muscles are significant determinants of balance and functional ability in older people. OBJECTIVE -To assess the strength of foot and ankle exercise on Dynamic and Static balance with Berg Balance Scale and Functional Reach Test respectively. PROTOCOL – A 4-week exercise protocol will be given for foot and ankle exercises which includes ankle dorsiflexion and plantar flexion, inversion and eversion which will be progressed with theraband, Heel raise, toe-raise, gradually progressing exercises with hold, Toe – curling, marble pick up in sitting position progressed to standing position, lunges progressing with hold. Berg balance scale and functional reach test for dynamic and static balance respectively will be taken before and after the intervention. Key Words – Foot and ankle exercise, Balance, Elderly |