| CTRI Number |
CTRI/2025/07/090279 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| 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
|
Virtual Reality vs Regular Exercise
What Works Best to Prevent Falls in Older Adults |
|
Scientific Title of Study
|
A comparative study to analyze the effects of task specific virtual reality training and cognitive behavioural therapy and conventional exercises on falls and balance in elderly people. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Muthulakshmi |
| Designation |
Research Scholar |
| Affiliation |
Dr M.G.R Educational and Research Institute |
| Address |
Faculty of Physiotherapy, SLMC Campus, Dr M.G.R Educational and Research institute, Adayalampattu, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
8680921760 |
| Fax |
|
| Email |
muthulakshmi.pt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Rajalaxmi |
| Designation |
Vice Principal |
| Affiliation |
Dr M.G.R EDUCATIONAL AND RESEARCH INSTITUTE |
| Address |
Faculty of Physiotherapy, ACS Campus, Dr M.G.R Educational and Research Institute, Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
rajalaxmi.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
K Muthulakshmi |
| Designation |
Research scholar |
| Affiliation |
Dr M.G.R Educational and Research Institute |
| Address |
Faculty Of Physiotherapy, SLMC Campus, Dr M.G.R Educational and Research Institute, Adayalampattu, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
8680921760 |
| Fax |
|
| Email |
muthulakshmi.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri lalithambigai medical college and hospital, Adayalampattu, Maduravoyal, Chennai, Tamil Nadu, India - 600095
ACS medical college and hospital, Velappanchavadi, Chennai, Tamil Nadu, India - 600071
Divine old age home, Maduravoyal, Chennai, Tamil Nadu, India - 600095
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 K Muthulakshmi |
ACS Medical College and Hospital |
ACS Medical College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai 600077
Chennai
TAMIL NADU |
8680921760
muthulakshmi.pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S. MEDICAL COLLEGE HOSPITAL A constituent Unit of Dr. M.G.R. EDUCATIONAL AND RESEARCH INSTITUTE (DEEMED TO BE UNIVERSITY) VELAPPANCHAVADI, CHENNAI -600077 INSTITUTIONAL ETHICS COMMITTEE Regd. No: ECR/1857/Inst/TN/2023 Dt: 5th July 2023 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly with falls history and balance issues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioural Therapy |
45 min/day for 4 days in a week for 12 weeks
|
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY EXERCISE |
45 min/day for 4 days in a week for 12 weeks |
| Intervention |
Task Specific Virtual Reality Training |
45 min/day for 4 days in a week for 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age between 65 to 80, both male and female.
Experience of fall in last 12 month
Mini Mental State score between 15- 26
People with TUG Score 14 to 20 Sec.
Impairment in Gait and Balance (POMA Score- 19 to 24)
Falls efficacy Scale greater than 70.
FIM score greater then 4. |
|
| ExclusionCriteria |
| Details |
Impaired vision and hearing
Inability to stand un aid for 60 sec
Geriatric depression scale greater then 8/15
Acute Severe pain
All type of Neurological disease
Dizziness-(greater than 39 DHI scale )
Balance disorder due to Vestibular issues.
Heart and respiratory diseases were excluded in this study.
Mentally unstable or non co-operative patients |
|
|
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 |
Berg Balance scale.
Balance Assessor (fall risk, single leg stance, limits of stability ) .
Montreal Cognitive Assessment (MoCA) .
Geriatric Depression Scale
|
Baseline
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
21/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is a Randomized parallel group, Multicenter trial comparing the efficacy of task specific virtual reality training and cognitive behavioural therapy for 45 minutes/day for 4 days in a week for 12 weeks to prevent falls and to improve balance in elderly. The primary outcome variables include balance, prevalence of falls, cognitive behaviour and depression level using tools namely Balance assessor, berg balance scale, Montreal cognitive assessment and geriatric depression scale. The outcomes will be taken at o weeks and at the end of 12 weeks. the values will be tabulated and evaluated statistically. |