Virtual Reality in Patients With Knee Osteoarthritis

Effectiveness of Virtual Reality in Patients With Symptomatic Knee Osteoarthritis

One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pain; Knee Osteoarthritis
• Intervention / Treatment: Other: Virtual reality; Other: conventional rehabilitation

Detailed Description

Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Basak Cigdem Karacay, Asst Prof; Phone Number: +9 0386 280 51 00.; Email: basakcigdem@hotmail.com

Study Locations

• Turkey
  • City Center
    • Kırşehir, City Center, Turkey, 40100
      • Recruiting
      • Kırşehir Ahi Evran University Faculty of Medicine
      • Contact: Basak Cigdem Karacay, Asist Prof; Phone Number: 0905445094803; Email: basak.cigdemkaracay@ahievran.edu.tr
      • Principal Investigator: Basak Cigdem Karacay, Asist Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

2

Arms and Interventions

Participant Group / Arm	Intervention / 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.	Other: Virtual reality; VR-based exercise program will be applied in addition to the conventional rehabilitation program, 5 days a week for a total of 3 weeks.; Other: conventional rehabilitation; The conventional exercise program will include 20 minutes(Transcutaneous Electrical Nerve Stimulation) TENS with conventional method, 4 minutes continue ultrason, 20 minutes hot pack.
Active Comparator: Control group; The conventional rehabilitation program at the hospital will be implemented in 15 sessions, 5 days a week.	Other: conventional rehabilitation; 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

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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
Visual Analog Scale	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
Visual Analog Scale	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.	7th week
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	Baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	7th week
Biodex Balance System	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.	Baseline
Biodex Balance System	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.	3th week
Biodex Balance System	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.	7th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 (SF36)	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)	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
Short Form 36 (SF36)	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.	7th week

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Basak Cigdem Karacay, Asst Prof, Kirsehir Ahi Evran University

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): May 28, 2024
• Primary Completion (Estimated): December 14, 2024
• Study Completion (Estimated): January 14, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pain; Quality of Life; Knee Osteoarthritis; virtual reaility
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2023-19/140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No