| CTRI Number |
CTRI/2024/07/070120 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| 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
|
A study on the effect of immersive virtual reality based exercises along with conventional exercises on quality of life in knee osteoarthritis patients |
|
Scientific Title of Study
|
Addition of Immersive Virtual Reality mediated program with Conventional Physiotherapy on Quality of Life in Knee Osteoarthritis - A Randomized Controlled Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R. Kamalakannan |
| Designation |
Associate Professor |
| Affiliation |
Srinivas University, Mangalore, Karnataka |
| Address |
Staff Cabin,
Musculoskeletal and Sports Physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar Campus,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9500931424 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R. Kamalakannan |
| Designation |
Associate Professor |
| Affiliation |
Srinivas University, Mangalore, Karnataka |
| Address |
Staff Cabin,
Musculoskeletal and Sports Physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar campus,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9500931424 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R kamalakannan |
| Designation |
Associate professor |
| Affiliation |
Srinivas university |
| Address |
staff cabin
Musculoskeletal and sports physiotherapy department
Institute of physiotherapy
Srinivas university
pandeshwar
mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9500931424 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal and Sports Physiotherapy department,
Srinivas University,
Pandeshwar Campus,
Mangalore-575001,
Karnataka.
Srinivas Medical college Hospital,
physiotherapy department,
Mukka,
Mangalore-574146,
Karnataka.
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajasekar S |
Institute of Physiotherapy, Srinivas University , Pandeshwar Campus |
Musculoskeletal and sports Physiotherapy department, Institute of Physiotherapy,
Srinivas University
Mangalore-575001.
Dakshina Kannada
KARNATAKA |
9448156719
s.rajasekarmpt@gmail.com |
| Dr Rajasekar S |
Srinivas Medical College Hospital |
Physiotherapy department, ground floor,
Mukka,
Mangalore-574146
Dakshina Kannada
KARNATAKA |
9448156719
s.rajasekarmpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas university Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy group |
Conventional Physiotherapy
(Patient Education Self-Directed/Self-Management + Conventional Exercises)
A booklet consisting of patient education will be provided to the patients which includes education on disease pathology and progression, treatments including exercise prescription along with conventional exercises.The exercises will be done under clinical supervision three days per week, for 6 weeks, with a treatment duration of 35 mins for conventional exercises
|
| Intervention |
Immersive Virtual Reality Group |
immersive virtual reality
group are provided with [Supervised VR Exercises+ Conventional Physiotherapy] that is with
Immersive virtual reality exercise is provided with REWIN HEALTH with CE and RoHS certification.(occulus quest head mounted device)
and Conventional Physiotherapy
(Patient Education Self-Directed/Self-Management + Conventional Exercises)
A booklet consisting of patient education will be provided to the patients which includes education on disease pathology and progression, treatments including exercise prescription along with conventional exercises are provided.The exercises will be done under clinical supervision three days per week, for 6 weeks, with a treatment duration of 35 mins for conventional exercises total duration for VR +conventional exercises will be 50 min.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with primary knee OA based on the American College of Rheumatology (ACR) clinical classification criteria, at least 3 of the following should be positive
Age should be greater than 50 years old
Morning stiffness should be less than 30 minutes
Crepitus on knee motion
Bony tenderness
Bony enlargement
No palpable warmth
Having unilateral or bilateral grade 2 or 3 of knee OA according to the Kellgren and Lawrence radiological gradings
a TSK-KA-11 score 23 or higher.
|
|
| ExclusionCriteria |
| Details |
have cognitive impairment,
have underwent a history of knee surgery,
joint infection
Rheumatoid arthritis of knee
inflammatory arthritis
any past six-month history of hip or knee replacement surgeries, intraarticular steroidal injections, arthroscopic surgeries.
Persons who are all in need of external support for walking
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of life by Knee Injury and Osteoarthritis Outcome Score (KOOS) |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fear of movement by Kinesiophobia by Tampa scale of kinesiophobia [Tampa scale of kinesiophobia Kannada version TSK-KA-11 |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
| Pain Self-Efficacy Questionnaire |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
| Pain Pressure Threshold by Algometry |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
| Knee Extensors Muscle Strength by Hand Held Dynamometry |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
| Functional Performance Test by 40Meter Fast paced Walk Test |
0 week of treatment,6th week of treatment,12th week of treatment,24th week of treatment. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/07/2024 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kamalakannan.pt@gmail.com].
- For how long will this data be available start date provided 07-04-2026 and end date provided 07-10-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Background and purpose As Osteoarthritis is one of commonest ailment the aging population of India encounters, exercises has been recommended as a first line of treatment, but as its persists for a long time the patients have been developed with the psychological negative adjustment in their behavior resulting in fear of movement that prevents them from doing exercises hence physiotherapy treatment have to focus not alone in physical domain improvement but also psychological domain by overcoming the fear of movement that is adding a any type of treatment that has to be exercises oriented but having psychological influence. procedure In this study two group are recruited , in the experimental group, immersive virtual reality based exercises are provided along with conventional physiotherapy which is compared to conventional physiotherapy alone and the quality of life ,fear for movement ,muscle strength, functional performance are measured with six weeks of treatment and follow up is done in 12th and 24th week to know the long lasting effect of the treatment. conclusion Hence the outcome will test the effect of the both treatments and that will help the humanity and the treatment providers by assisting to have a evidence based practice. |