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
|
|
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
|
|
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. |