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CTRI Number  CTRI/2024/11/077046 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
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   Comparison of game-based training and proprioceptive training to improve balance and reduce fall risk in individuals with knee osteoarthritis. 
Scientific Title of Study   Comparative effectiveness of Nintendo Wii-based virtual reality training and proprioceptive training on balance and fall risk in knee osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Sharma 
Designation  Postgraduate Student (Masters of Physiotherapy) 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre - Institue of Rehabilitation Sciences, Rehabilitation Department, 2nd Floor, Sector-C, Vasant Kunj

South West
DELHI
110070
India 
Phone  9582285434  
Fax    
Email  ankita.anku0710@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitra Kataria 
Designation  Professor, Principal, ISIC-IRS 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Principal Office, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Opposite Vasant Valley School, IAA Colony, Sector-C, Vasant Kunj

South West
DELHI
110070
India 
Phone  9810310670  
Fax    
Email  chitrakataria@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Megha Nijhawan PT 
Designation  Associate Professor 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Rehabilitation Department, 2nd Floor, Sector-C, Vasant Kunj

South West
DELHI
110070
India 
Phone  8802021752  
Fax    
Email  physiomegha@gmail.com  
 
Source of Monetary or Material Support  
Material Support - Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj, South West Delhi-110070, India 
 
Primary Sponsor  
Name  None 
Address  N/A 
Type of Sponsor  Other [Self] 
 
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 
Ankita Sharma  Indian Spinal Injuries Centre  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Rehabilitation Department, 2nd Floor, Sector-C, Vasant Kunj
South West
DELHI 
9582285434

ankita.anku0710@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Indian Spinal Injuries Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nintendo Wii-based virtual reality training  Nintendo Wii-based virtual reality training will be given along with conventional training for 12 sessions over the course of 4 weeks. 
Comparator Agent  Proprioceptive training  Proprioceptive training will be given along with conventional training for 12 sessions over the course of 4 weeks. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed bilateral knee osteoarthritis with Kellgren and Lawrence Grade 2 and 3, Fulfilling the combined clinical and radiographic criteria of knee OA established by the American College of Rheumatology, Ability to comprehend and follow instruction. 
 
ExclusionCriteria 
Details  Diagnosed with secondary knee osteoarthritis.
History of neurological diseases, cognitive deficits and hearing, vision or any vestibular problem.
History of surgery at knee, hip, ankle, or/and foot.
History of corticosteroid injection in last 3 months.
History of oral corticosteroid in the last 6 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Balance using Berg balance scale and centre of pressure (using PROKIN 252N), Fall risk using timed up and go test and fall efficacy scale-I and functional disability using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)  Day 0 (baseline assessment, pre-test) and at 4 week (post-test) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/11/2024 
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="5"
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  

Osteoarthritis (OA) is a degenerative joint condition causing pain, swelling and stiffness, affecting a person’s ability to move freely. People with knee OA have decreased muscle strength and joint position sense, leading to balance impairment and increased fall risk during daily activities. 

The Nintendo Wii includes a balance board and video game console. It is feasible and acceptable exergaming tool to improve balance and decrease risk of falling in adults with knee OA. Proprioceptive trainings are the programs that work to enhance or restore proprioception.

Nintendo Wii-based virtual reality training and proprioceptive training are effective in improving balance and reducing fall risk in knee osteoarthritis. However, to best of our knowledge, no study has been conducted in order to compare the effectiveness of these two protocols.

People will be screened based on inclusion and exclusion criteria and then will be enrolled into 2 groups using random allocation software: Group A will receive Nintendo Wii-based virtual reality training along with conventional training and Group B will receive proprioceptive training along with conventional training for 12 sessions, 3 sessions per week for 4 weeks. Pre and post-intervention assessment will be done.

The outcome measurement will be done by using berg balance scale and centre of pressure (using Prokin 252N) for balance, timed up and go test and fall efficacy scale-I for fall risk and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional disability. Variation in the pre and post outcome measure will help us to find out which training is more effective in improving balance, reducing fall risk, and decreasing functional disability in individuals with knee osteoarthritis.

 
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