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CTRI Number  CTRI/2025/08/092393 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
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   "Exercises to Improve Balance, Coordination, and Reaction Time in Older Adults: Comparing Multisensory Training with Regular Balance Exercises" 
Scientific Title of Study   Effectiveness of Multisensory Exercises vs Conventional Exercises on Balance, Co-ordination and Reaction Time 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  Dr Anisha Gulati 
Designation  PhD Scholar 
Affiliation  Krishna College of Physiotherapy Malkapur Karad 
Address  Department of Neuro-Physiotherapy, Ground Floor,Krishna College of Physiotherapy Malkapur,Karad.

Satara
MAHARASHTRA
415539
India 
Phone  9082403547  
Fax    
Email  dranishagulati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anisha Gulati 
Designation  PhD Scholar 
Affiliation  Krishna College of Physiotherapy Malkapur Karad 
Address  Department of Neuro-Physiotherapy, Ground Floor,Krishna College of Physiotherapy Malkapur,Karad.

Satara
MAHARASHTRA
415539
India 
Phone  9082403547  
Fax    
Email  dranishagulati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suraj Kanase 
Designation  Professor 
Affiliation  Krishna College of Physiotherapy Malkapur Karad 
Address  Department of Neuro-Physiotherapy,Ground Floor,Krishna College of Physiotherapy Malkapur,Karad.

Satara
MAHARASHTRA
415539
India 
Phone  9881577676  
Fax    
Email  drsurajkanase7@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth Deemed to be University Research department, Malkhapur Karad, India, 415539 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth Research department 
Address  Krishna Vishwa Vidyapeeth, deemed to be university,Malkapur Karad, India, 415539 
Type of Sponsor  Other [Deemed University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnisha Gulati  Krishna Hospital  Department of Neuro-Physiotherapy, Ground Floor, Krishna College of Physiotherapy, Malkhapur,Karad
Satara
MAHARASHTRA 		 9082403547

dranishagulati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Krishna Institute of Medical Sciences, Deemed to be University, Karad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G26||Extrapyramidal and movement disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Balance Training Exercises  Balance, Co-ordination & reaction time exercises to geriatric population. Total Duration- 4weeks 
Intervention  Multisensory exercises & conventional balance exercises to Geriatric population.   Balance, co-ordination & reaction time Training Exercises to Geriatric population. Total Duration- 4 weeks 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  History of atleast 1 self-reported fall or balance related difficulty in past year
Able to walk independently or with minimal assistance eg cane
Cognitively intact (MMSE Score greater than or equal to 24)
Ability to provide informed consent and participate in exercise program 
 
ExclusionCriteria 
Details  Severe musculoskeletal or neurological conditions affecting mobility (e.g., advanced Parkinson’s, stroke, severe arthritis). Neurological disorders affecting balance (e.g., Parkinson’s disease, stroke).

Use of assistive devices that limit dynamic balance exercise.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance- Assessed using Minibest scale, cordination assessed using lemocot, reaction time assessed using choice stepping reaction time   Baseline & 4 Weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
fear of fall assessed using fall efficacy scale  Baseline & 8weeeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/11/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dranishagulati@gmail.com].

  6. For how long will this data be available start date provided 02-05-2028 and end date provided 02-05-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study investigates the effectiveness of multisensory exercises in improving balance, coordination, and reaction time in geriatric population. With aging, declines in sensory systems such as vision, proprioception, and vestibular function increase fall risk and reduce mobility (Lord et al., 2001; Horak, 2006). Traditional balance exercise primarily targets a single sensory system, potentially limiting its effectiveness (Schwesig et al., 2016). This study hypothesizes that a multisensory approach integrating visual, proprioceptive, and vestibular exercises will enhance balance and coordination more effectively than conventional methods. A randomized controlled trial (RCT) will be conducted with 60 older adults, divided into a multisensory exercise group and a conventional balance exercise group. Pre-and post-exercise assessments will measure balance, coordination, reaction time, and fall risk. Expected outcomes include improved postural stability, reduced fall risk, and enhanced sensory integration (Gillespie et al., 2012). Findings from this research will support the development of more comprehensive rehabilitation strategies for older adults, ultimately improving mobility and quality of life. 

 
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