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CTRI Number  CTRI/2025/10/096209 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparing two types of exercise (dual task and virtual reality) to improve strength balance and quality of life in older adults 
Scientific Title of Study   Effect of dual task training versus head mounted virtual reality on strength balance and quality of life in elderly a randomized clinical trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutuja Dudhane 
Designation  Intern 
Affiliation   
Address  Advanced Physiotherapy Centre, Room No. 39, Sagar Floor, Advanced Physiotherapy Centre Dr Prabhakar Kore Hospital and Medical Research Centre, Belgaum, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  9822637402  
Fax    
Email  rutujadudhane13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Muragod  
Designation  Professor and Head of Department of Geriatrics Physiotherapy 
Affiliation  KAHER Institute Of Physiotherapy  
Address  Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India 
Phone  9164694970  
Fax    
Email  anilmuragod@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Anil Muragod  
Designation  Professor and Head of Department of Geriatrics Physiotherapy 
Affiliation  KAHER Institute Of Physiotherapy  
Address  Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India 
Phone  9164694970  
Fax    
Email  anilmuragod@klekipt.edu.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  KLEs Dr Prabhakar Kore Hospital and Medical Research Centre 
Address  Advanced Physiotherapy Centre Room No. 39, Sagar Floor, Dr Prabhakar Kore Hospital and Medical Research Centre, India, Belgaum, Karnataka 
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 
Rutuja Dudhane  Old Age homes in Belagavi, Karnataka  Room no:39 Advanced Physiotherapy Centre, KLEs Dr Prabhakar Kore Hospital and Medical Research Centre
Belgaum
KARNATAKA 		 9822637402

rutujadudhane13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee, KLEs Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  mild to moderate balance impairement 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A receives Dual Task Training Group B receives Head Mounted Virtual Reality training.  Group A receives Dual Task Training. This intervention involves performing balance exercises and cognitive tasks simultaneously for 45 minutes. The specific dual tasks include activities such as walking while performing serial subtraction, walking while carrying a tray, walking while talking, and walking while holding a glass of water or a ball on a round tray will be given for 2 days per week for 6 weeks  
Comparator Agent  Group B receives Head Mounted Virtual Reality training  Group B receives Head Mounted Virtual Reality training. The 45 minute session includes a 5 minute warm up, followed by 30 minutes of VR training and concludes with a 5 minute cool down. The training utilizes balance focused games, which are VR based games accessed using a smartphone such as Puzzle games with movement and walk with prank will be given for 2 days per week for 6 weeks 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants must be of all genders, over 60 years of age, and willing to provide informed consent and complete all trial procedures. Functional mobility is required, specifically the ability to ambulate at least 10 meters without using an assistive device. Cognitive eligibility is defined by a Mini-Mental State Examination (MMSE) score of 24 or greater. Furthermore, all included participants must exhibit a degree of balance impairment, defined by a Berg Balance Scale (BBS) score between 21 and 56, covering both mild impairment (BBS 41 to 56) and moderate impairment (BBS 21 to 40). 
 
ExclusionCriteria 
Details  Individuals with recent fractures, lower limb injuries and surgeries (past 6 months).
Any diagnosed case of respiratory , neurological or cardiovascular condition.
Severe visual impairment not correctable with lenses, or vestibular disorder producing instability. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Modified 30s sit- stand test
Berg Balance Scale
WHOQOL-BREF 		 0-6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nill  Nill 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   28/10/2025 
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="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   This study is a 6-month prospective, parallel-group, Randomized Clinical Trial RCT designed to compare the effects of conventional Dual-Task Training versus Head-Mounted Virtual Reality HMD-VR on lower limb strength, balance, and quality of life in elderly participants. A minimum of 36 participants (18 per group), aged over 60, will be recruited from Old Age Homes in Belagavi, India. Participants will be randomized into two arms: Group A will receive Conventional Dual-Task Training (balance exercises combined with cognitive tasks) and Group B will receive HMD-VR (balance-focused games using a VR device). Both interventions will be delivered for 45 minutes per session, two days per week for 6 weeks. The primary outcomes Lower Limb Strength (Modified 30s Sit-Stand Test), Balance (Berg Balance Scale), and Quality of Life (WHOQOL-BREF) will be measured at baseline and post-intervention. Statistical analysis will involve Paired t tests (or Wilcoxon signed rank test) and Independent samples t test (or Mann Whitney U test) for group comparisons, with a p value less than 0.05 considered significant. 
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