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CTRI Number  CTRI/2024/04/066234 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
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   Effectiveness of Action Observation Therapy with Otago Exercises versus Otago exercises alone on Balance in Community Dwelling Older Adults. 
Scientific Title of Study   Added Effect of Action Observation Therapy with Otago Exercises Versus Otago Exercises on Balance in Community Dwelling Older Adults. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Phulpagar  
Designation  PG student  
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade Pune  
Address  MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230

Pune
MAHARASHTRA
410507
India 
Phone  7776872903  
Fax    
Email  snehaphulpagar1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Chitre  
Designation  Professor  
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade Pune  
Address  MAEERS college of Physiotherapy OPD Building, 2nd floor neurophysiotherapy department cabin no A 219

Pune
MAHARASHTRA
410507
India 
Phone  9049998861  
Fax    
Email  priyasatpute@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumitra Sakhawalkar  
Designation  Associate Professor  
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade Pune  
Address  MAEERS college of Physiotherapy OPD Building, 2nd floor Neurophysiotherapy department cabin no A 218

Pune
MAHARASHTRA
410507
India 
Phone  9049998861  
Fax    
Email  sumitra26@mitmimer.com  
 
Source of Monetary or Material Support  
MAEERS College Of Physiotherapy Talegaon Dabhade 410507 
 
Primary Sponsor  
Name  MAEERS College of Physiotherapy Talegaon Dabhade 410507  
Address  MAEERS college of Physiotherapy OPD building 2nd floor near talegaon railway station talegaon dabhade 410507 
Type of Sponsor  Private medical college 
 
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 
Dr Priya Chitre   MAEERS COLLEGE OF PHYSIOTHERAPY TALEGAON DABHADE   MAEERS college of Physiotherapy OPD building 2nd floor Neuro department A230
Pune
MAHARASHTRA 		 9049998861

priyasatpute@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERS College of Physiotherapy Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  community dwelling older adults with balance issues 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Action observation therapy with otago exercises   Action Observation Training will be conducted on the based on the Otago exercises program . Participants will be asked to watch the video on laptop placed at eye level in front of them while sitting comfortably in a chair with armrests. Otago exercises containing strength and balance exercises. Protocol duration 6 weeks 3 times per week protocol will be given  
Comparator Agent  Otago exercises   Otago exercises will be given to another group for 50 minutes which contains only strength and balance exercise program . Protocol duration 6 weeks 3 days per week protocol will be given  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1)Community dwelling older adults
2)Both male and female
3)Normal cognition
4)Able to walk 10 m with or without aid
5)Berg balance scale score 21 to 56  
 
ExclusionCriteria 
Details  1)High risk of fall 19
2)Lower Limb deformities, contractures
3)Musculoskeletal injuries or fracture in past 6 months .
4)Presence of vestibular dysfunction
5)Cardiovascular or cerebrovascular diseases affecting balance .
6)Traumatic brain injury , epilepsy and other neurological conditions 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tinetti performance oriented mobility assessment scale   0 week and 6 week  
 
Secondary Outcome  
Outcome  TimePoints 
Functional reach test for static balance   0 week and 6 week  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 1/ Phase 2 
Date of First Enrollment (India)   23/05/2024 
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 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   Aging is a process causing attritional changes in the body, leading to loss of movement and balance. Visual, somatosensory, and vestibular systems play key roles in balance decline with age. Negative impacts of aging on balance include reduced strength, muscle mass, bone density, central nervous system atrophy, and peripheral sensory decline. Balance issues are linked to fear of falling and decreased confidence, affecting quality of life. The Otago exercise program, incorporating strengthening, balance training, and walking, is an effective protocol for addressing balance concerns in older adults.  Action Observation Therapy improves motor performance in older adults by activating mirror neurons and enhancing cortical excitability. Action Observation Therapy improves motor performance in older adults by activating mirror neurons and enhancing cortical excitability, benefiting balance in conditions like Parkinson’s, multiple sclerosis, and stroke. However, there is limited research on its effect on balance in the elderly. Otago exercises target various balance-related systems, but the addition of cognitive intervention training has not been studied. A study aims to evaluate the combined effect of Action Observation Therapy and Otago exercises on balance in Community Dwelling older adults.
Protocol-Intervention protocol Group A will be given Otago exercises 3 times a week for 6 weeks .Group B will be given Action observation therapy with otago exercises 3 times a week for 6 weeks .Action observation exercises will be conducted on the base of otago exercises .Participants will be asked to watch the video on laptop placed on eye level in front of them while sitting comfortably in a chair with arm rests . While watching the video participants will be not allowed to follow the contents of the video or to move . The action observation video content same as components of otago exercises program.
 
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