Virtual Reality in Patients With Knee Osteoarthritis
Effectiveness of Virtual Reality in Patients With Symptomatic Knee Osteoarthritis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Basak Cigdem Karacay, Asst Prof
- Phone Number: +9 0386 280 51 00.
- Email: basakcigdem@hotmail.com
Study Locations
-
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City Center
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Kırşehir, City Center, Turkey (Türkiye), 40100
- Kırşehir Ahi Evran University Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of chronic (>3 months) knee osteoarthritis between the ages of 40-85
- Kellgren and Lawrence Score ≥ 2 on knee radiograph
- Visual Analogue scale result VAS 4-8
Exclusion Criteria:
- Orthopedic surgery performed on the lower extremity
- Cognitive dysfunction (Mini Mental Test Score <23)
- Having received any treatment for knee osteoarthritis in the last 6 months
- Following any ongoing exercise program (tai chi, pilates, yoga, fitness)
- History of ligament and ligament injury around the knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Experimental Group
In addition to the conventional rehabilitation program at the hospital, virtual reality exercise will be applied in 15 sessions, 5 days a week.
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VR-based exercise program will be applied in addition to the conventional rehabilitation program, 5 days a week for a total of 3 weeks.
The conventional exercise program will include 20 minutes(Transcutaneous Electrical Nerve Stimulation) TENS with conventional method, 4 minutes continue ultrason, 20 minutes hot pack.
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Active Comparator: Control group
The conventional rehabilitation program at the hospital will be implemented in 15 sessions, 5 days a week.
|
The conventional exercise program will include 20 minutes(Transcutaneous Electrical Nerve Stimulation) TENS with conventional method, 4 minutes continue ultrason, 20 minutes hot pack.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline
|
Visual analog scale (VAS) was used for pain assessment.
VAS is a 10-point Likert scale.
Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain.
Increased scores indicate higher pain levels.
|
Baseline
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Visual Analog Scale
Time Frame: 3th week
|
Visual analog scale (VAS) was used for pain assessment.
VAS is a 10-point Likert scale.
Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain.
Increased scores indicate higher pain levels.
|
3th week
|
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Baseline
|
WOMAC was used to assess disability in patients with knee osteoarthritis.
The WOMAC assesses pain, stiffness and physical function and consists of 24 items.
Total score is between 24 and 120 points.
A low score indicates mild illness, a high score indicates severe illness.
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Baseline
|
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The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 3th week
|
WOMAC was used to assess disability in patients with knee osteoarthritis.
The WOMAC assesses pain, stiffness and physical function and consists of 24 items.
Total score is between 24 and 120 points.
A low score indicates mild illness, a high score indicates severe illness.
|
3th week
|
|
Biodex Balance System
Time Frame: Baseline
|
The balance assessment of the participants will be made with the Biodex Balance Systems device.
During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
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Baseline
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Biodex Balance System
Time Frame: 3th week
|
The balance assessment of the participants will be made with the Biodex Balance Systems device.
During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.
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3th week
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form 36 (SF36)
Time Frame: Baseline
|
In the study, quality of life will be evaluated using Short Form-36 (SF-36).
SF-36 is not specific to any disease group.
This scale consists of 36 questions; There are 8 subgroups: general health, physical function, physical role difficulty, pain, energy, social function, emotional role difficulty, and mental health.
A high score is an indicator of good health.
|
Baseline
|
|
Short Form 36 (SF36)
Time Frame: 3th week
|
In the study, quality of life will be evaluated using Short Form-36 (SF-36).
SF-36 is not specific to any disease group.
This scale consists of 36 questions; There are 8 subgroups: general health, physical function, physical role difficulty, pain, energy, social function, emotional role difficulty, and mental health.
A high score is an indicator of good health.
|
3th week
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Basak Cigdem Karacay, Asst Prof, Kirsehir Ahi Evran Universitesi
Publications and helpful links
General Publications
- Wi, S. Y., & Kang, J. H. (2012). The effects of virtual reality interactive games on the balance ability of elderly women with knee osteoarthritis. Journal of Korean Society of Physical Medicine, 7(3), 387-393.
- Lin YT, Lee WC, Hsieh RL. Active video games for knee osteoarthritis improve mobility but not WOMAC score: A randomized controlled trial. Ann Phys Rehabil Med. 2020 Nov;63(6):458-465. doi: 10.1016/j.rehab.2019.11.008. Epub 2020 Jan 22.
- Nambi G, Abdelbasset WK, Elsayed SH, Khalil MA, Alrawaili SM, Alsubaie SF. Comparative effects of virtual reality training and sensory motor training on bone morphogenic proteins and inflammatory biomarkers in post-traumatic osteoarthritis. Sci Rep. 2020 Sep 28;10(1):15864. doi: 10.1038/s41598-020-72587-2.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023-19/140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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