| CTRI Number |
CTRI/2025/07/090845 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study Using Virtual Reality, Pain Education, and Movement Imagery to Reduce Pain, Fear of Movement, and Improve Daily Life in People with Knee Osteoarthritis |
|
Scientific Title of Study
|
Effects of Virtual Reality versus Sham Virtual Reality Training Combined with Pain Neuroscience Education and Graded Motor Imagery on Pain, Quality of Life, Functional Disability, and Kinesiophobia 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 |
Dr Shetty Aparna Dinesh |
| Designation |
PhD Scholar |
| Affiliation |
KLE College of Physiotherapy, Hubballi, KAHER (Deemed-to-be-University), Belagavi |
| Address |
Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol Cross, Kotagundhshi,Gabbur
Dharwad
KARNATAKA
580028
India |
| Phone |
8855979959 |
| Fax |
|
| Email |
shettyaparna786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Mukkannavar |
| Designation |
Professor & Principal, HOD of Orthopedic Physiotherapy |
| Affiliation |
KLE College of Physiotherapy, Hubballi, KAHER (Deemed-to-be-University), Belagavi |
| Address |
Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol Cross, Kotagundhshi, Gabbur
Dharwad
KARNATAKA
580028
India |
| Phone |
9448231520 |
| Fax |
|
| Email |
drshant24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shetty Aparna Dinesh |
| Designation |
PhD Scholar |
| Affiliation |
KLE College of Physiotherapy, Hubballi, KAHER (Deemed-to-be-University), Belagavi |
| Address |
Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol Cross, Kotagundhshi, Gabbur
Dharwad
KARNATAKA
580028
India |
| Phone |
8855979959 |
| Fax |
|
| Email |
shettyaparna786@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Cooperative hospital, Shree Shakti Road, Opp. Apasara Theatre, Hubballi, Karnataka, India - 580020 |
|
|
Primary Sponsor
|
| Name |
Dr Shetty Aparna Dinesh |
| Address |
Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol cross, Kotagundhshi, Gabbur, Hubballi, Dharwad, Karnataka -580028, India |
| 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 |
| Dr Shetty Aparna Dinesh |
KLE Jagadguru Gangadhar Mahaswamigalu Moorusaviramath Medical College and Hospital |
Department of Orthopedic Physiotherapy, Room no. 6, Gabbur Cross, Hubballi, Karnataka, India - 580020
Dharwad
KARNATAKA |
8855979959
shettyaparna786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Virtual reality training combined with Pain Neuroscience Education and Graded Motor Imagery |
The participants in the comparator group will receive non immersive functional and mobility training using 2D Virtual Reality (VR) through the Meta Quest headset. The program includes: Pain Neuroscience Education (PNE) delivered over 2 weeks using a bilingual (Kannada and English) educational pamphlet, Graded Motor Imagery (GMI) over the next 6 weeks, comprising laterality recognition, motor imagery exercises, and mirror therapy, followed by 2 weeks of non immersive VR exposure, involving passive viewing of functional mobility activities on a flat 2D screen without interaction using VR Meta quest headset. Additionally, individualized physiotherapy exercises will be prescribed based on OARSI/ACR guidelines, tailored to each participant’s needs, and to be performed at home for a total duration of 10 weeks. The intervention will be conducted 3 times per week for 10 weeks at the OPD, followed by 4 weeks of monitored home exercises. Outcome measurements will be taken at baseline (0 week), at the end of intervention (10th week), and after follow-up (14th week). |
| Intervention |
Virtual reality training combined with Pain Neuroscience Education and Graded Motor Imagery |
The participants in the intervention group will receive immersive functional and mobility training using 3D Virtual Reality (VR) through the Meta Quest headset. The program includes: Pain Neuroscience Education (PNE) delivered over 2 weeks using a bilingual (Kannada and English) educational pamphlet, Graded Motor Imagery (GMI) over the next 6 weeks, comprising laterality recognition, motor imagery exercises, and mirror therapy, followed by 2 weeks of immersive VR-based functional training, simulating real-life mobility tasks. Additionally, individualized physiotherapy exercises will be prescribed based on OARSI/ACR guidelines, tailored to each participant’s needs, and to be performed at home for a total duration of 10 weeks.
The intervention will be conducted 3 times per week for 10 weeks at the OPD, followed by 4 weeks of monitored home exercises. Outcome measurements will be taken at baseline (0 week), at the end of intervention (10th week), and after follow-up (14th week). |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
I. Participants consent to a free participation to the study.
II. All gender, aged between 40 and 64 years.
III. Participants with a diagnosis, according to the American College of Rheumatology criteria 3 out of 6 symptoms present.
IV. Kellgren and Lawrence classification Grade II- III or the Unilateral knee involvement.
V. Participants with persistent chronic knee pain with symptoms for more than 3 months.
VI. Participants reported pain as three or higher cm on a visual analog scale (VAS) during activity
VII. Participants with adequate 24 points on the Mini-Mental State Examination (MMSE)
|
|
| ExclusionCriteria |
| Details |
I. Any recent injury at hip, knee and ankle or surgery to the lower extremities within 6 Months.
II. A history of systemic inflammatory arthritis, or septic arthritis.
III. Participants with severe language comprehension deficits.
IV.Corticosteroids in the knees in the last six months.
V. Presence of cardiovascular disease
VI. A history of epilepsy or other neurological disorders.
VII. Participants with hearing loss, vestibular or balance disorder.
VIII. Participants with visual impairment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
I. Visual Analogue Scale
II. Knee injury and Osteoarthritis Outcome Score
III. Short-Form 36-Item Health Survey (SF-36)
IV. Tampa Scale of Kinesiophobia (TSK) |
0, 10th week and 14th week (3 time lines) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go |
0, 10th week and 14th week (3 time lines) |
| Dynamometer - Lower limb strength (JAMAR) |
0, 10th week and 14th week (3 time lines) |
| The Pain Catastrophizing Scale (PCS) |
0, 10th week and 14th week (3 time lines) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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)
|
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
|
Knee osteoarthritis is a leading cause of chronic pain and disability, often requiring an innovative and multimodal treatment approach aimed at reducing pain, improving quality of life, enhancing functional ability, and decreasing fear of movement. This randomized, placebo-controlled trial compares the effects of Virtual Reality (VR) versus Sham VR, both combined with Pain Neuroscience Education (PNE), Graded Motor Imagery (GMI), and tailored, patient-centered physiotherapy exercises in individuals with knee osteoarthritis. The intervention will be delivered over 10 weeks through supervised OPD sessions, followed by four weeks of home-based continuation. Outcome measures will be assessed at baseline, post-intervention (10th week), and follow-up (14th week). The findings aim to support the development of standardized protocols for integrating these approaches, offering comprehensive strategies that address both the physical and psychological aspects of KOA. The results may also help justify investments in VR technology and inform evidence-based guidelines for modern, technology-enhanced rehabilitation in clinical practice. |