| 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
|
|
|
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
|
|
|
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. |