| CTRI Number |
CTRI/2025/03/081599 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhancing Balance in Older Adults: The Impact of Gaze Stability Exercises in Balance Training |
|
Scientific Title of Study
|
Effect Of Balance Training with and without gaze stability exercises on Balance For Geriatric Population-Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja Amol Hatkar |
| Designation |
MPT Student |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, S V Road, Vile Parle(w)
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9975258894 |
| Fax |
|
| Email |
rutujahatkar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailja Mehta |
| Designation |
Assistant professor - Physiotherapist |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9825382610 |
| Fax |
|
| Email |
Shailja.Mehta@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailja Mehta |
| Designation |
Assistant professor - Physiotherapist |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West
MAHARASHTRA
400056
India |
| Phone |
9825382610 |
| Fax |
|
| Email |
Shailja.Mehta@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, ground floor,Nanavati Max Super Specality Hospital, SV Road, Vile Parle West, Mumbai-400056 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Super specialty Hospital |
Department of Physiotherapy, Ground floor, Sv road, Vile Parle west
Mumbai
MAHARASHTRA |
9825382610
shailja.mehta@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Dr Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Youngest old geriatric population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
balance training exercises |
It is a 4 week intervention with total 12 sessions - 3 sessions per week (alternate days ) |
| Intervention |
Gaze stability exercises with balance training |
Its a 4 week intervention with total 12 sessions - 3 sessions per week(alternate days) |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Moderate fall risk berg balance scale scoring 21 to 40
Individual with balance or mobility problem but normal vestibular function
|
|
| ExclusionCriteria |
| Details |
Presence of neurological or ENT disorders affecting balance
Severe hearing, vision and communication impairement
Recent musculoskeletal impairement or any recent surgery
Cardiovascular disease such as uncontrolled hypertension or cardiac arrhythmia, recurrent dizziness
|
|
|
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 |
| MiniBest Test |
Baseline and after 4 weeks ofintervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale |
Baseline and after 4 weeks of intervention |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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 Balance training with and without gaze stability exercises on balance for geriatric population - Randomised control trial INTRODUCTION: Gaze stability plays a crucial role
in postural control by ensuring clear vision and minimizing body sway, which is
essential for maintaining balance in older adults. Research indicates that gaze
stability exercises can significantly enhance balance and reduce fall risk in
the geriatric population. Studies have shown that incorporating gaze training
into balance programs improves postural control and mobility while reducing
fear of falling. This randomized controlled trial aims to compare the effects
of balance training with and without gaze stability exercises on balance
outcomes in older adults, providing insights into their potential role in fall
prevention strategies
RATIONALE: As
aging progresses, balance impairments become a major concern, increasing the
risk of falls and affecting the overall quality of life in the geriatric
population. Falls are a leading cause of injury and disability in older adults,
often resulting from deficits in postural control, sensory integration, and
gaze stability.Balance training is a well-established intervention
for improving postural control in older adults. However, gaze stability
exercises, which focus on enhancing visual-vestibular interaction, may further
contribute to balance improvement by refining head and eye coordination and
reducing dizziness or unsteadiness. Despite their potential benefits, limited
research has explored the combined effects of balance training with gaze
stability exercises in the elderly.This study aims to compare the effects of balance
training with and without gaze stability exercises to determine their impact on
balance outcomes in the geriatric population. The findings could provide
valuable insights into optimizing fall prevention strategies and enhancing
mobility in older adults. AIM: To
evaluate the effect of Gaze Stability exercises combining with balance
exercises on balance in geriatric population
OBJECTIVE:
-
To assess the effectiveness of gaze
stability exercises combining with balance exercises on balance in geriatric population
-
To compare the effectiveness between two
groups on static balance in geriatric
population
OUTCOME
MEASURE: MiniBest Test
PROTOCOL:
There are 2 groups, control group and intervention group. The intervention
group is given gaze stability exercises with balance exercises for 4 weeks and
control group is given only balance exercises for 4 weeks. Balance is assessed
with MiniBest Test. Above mentioned test will be performed before and after the
intervention period.
KEY WORD:
Gaze stability, Balance, Geriatric |