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CTRI Number  CTRI/2020/12/029906 [Registered on: 18/12/2020] Trial Registered Prospectively
Last Modified On: 17/12/2020
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   Effect of Fully Immersed Virtual Reality versus Otago exercises on balance and cognition in elderly population. A Randomized Clinical Trial 
Scientific Title of Study   Effect of Fully Immersed Virtual Reality versus Otago exercises on balance and cognition in elderly population. A Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Thakkar 
Designation  Post graduate 
Affiliation  KLE Academy of Higher Education and Research Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy, Department of Neuro physiotherapy Opd no.19, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9980995483  
Fax    
Email  thakkarmansi06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjiv Kumar 
Designation  Professor 
Affiliation  KLE Academy of Higher Education and Research Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy,Department of Neuro physiotherapy Opd no.19, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  09448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Mansi Thakkar 
Designation  Post graduate 
Affiliation  KLE Academy of Higher Education and Research Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy, Department of Neuro physiotherapy Opd no.19, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9980995483  
Fax    
Email  thakkarmansi06@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research Institute of Physiotherapy, Nehru nagar, Belagavi,590010,Karnataka, India. 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy,Belagavi 590010,Karnataka, India. 
Type of Sponsor  Research institution and hospital 
 
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 
Mansi Thakkar  KLE Institute of Physiotherapy Department of Neuro Physiotherapy Opd no 19  KLE Academy of Higher Education and Research, Institute of Physiotherapy, Department of Neuro Physiotherapy Opd no:19, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA 
9980995483

thakkarmansi06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIPT Institutional Research and Ethical Committee  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 
Intervention  Fully Immersed virtual Reality   subjects fulfilling the inclusion and exclusion criteria will be trained with head mounted virtual reality device (oculuc go- standardized tool used in research and improving balance)in standing position. the subject has to maintain balance by using his/her ankle, knee, hip and trunk strategies while tilting head or moving around as and when appropriately responding to the game being played in the VR device. cognitive therapy will be given to all the subjects followed by VR training. this will include calculations, attention, recall, memory and intelligence. the intervention will be carried out for 3 days/ week and for 3 weeks. duration of each session will be 40 mins (25 mins VR and 15 mins of cognitive training) including subsequent rest in between.  
Comparator Agent  otago exercises  these are home based exercise program for elderly population for improving balance.subjects fulfilling the inclusion and exclusion criteria will be treated in supine, sitting and standing position using 1kg weight cuff at the ankle. cognitive therapy will be given to all the subjects followed by exercise programme. it will include calculations, attention, recall, memory and intelligence. the intervention will be carried out for 3 days/ week and for 3 weeks. duration of each session will be 45 mins (30 mins of otago exercise and 15 mins of cognitive training) including subsequent rest in between. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1)subjects between 65-95 years of age.
2)both male and female subjects.
3)apparently healthy individuals
4)independent ambulation (who can complete get up and go test, berg balance score equal or >21)
5) subjects who can follow commands
6)willing to participate 
 
ExclusionCriteria 
Details  1) subjects having any cardiovascular or respiratory disorders.
2) chronic neurological conditions
3) mental illness
4) blind and deaf
5) fractures
6) amputees 
 
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 
Berg Balance Scale
KIPT Functional Assessment Scale 
Base line and at end of 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
6-minute walk test
get-up and go test
multi-directional functional reach test 
Base line and at end of 3 weeks 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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/ Phase 3 
Date of First Enrollment (India)   20/12/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Physical activity has an important role in maintaining health, especially for senior citizen. Maintaining balance and coordination and improving functional abilities and is essential for elderly as risk of falling can result in loss of independence or in severe cases may lead to significant morbidity or death.Increasing in ageing is inversely proportional to by cognitive deterioration and functional capacities which often lead deficits in physical performance and walking. These changes occur even in the absence of diseases. Poor balance hampers activities of daily living, and leads to poor quality of life.
Otago Exercise Program (OEP) consist of resistance and balance training exercises, proving it’s success in improving balance and lowering risk of falls and also improves cognitive function upto certain extent.
Virtual reality being an emerging technology, used for physical rehabilitation,9 helps in improving static and dynamic balance along with postural stability and provides biofeedback.
Cognitive dysfunction shows direct correlation with balance impairment and risk of falls. 
Evidence suggest that poor mobility may be associated with poor cognitive function, and hence it becomes important to train both these aspects. Combined effect of otago exercise along with cognitive training lacks its evidence in research. Moreover, fully immersive technique of VR and cognitive training is not much explored in geriatric population and hence this study is been taken up, to add on to the knowledge of research.
 
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