Virtual Reality in Patients With Knee Osteoarthritis

Pain Clinical Trial

Official title:

Effectiveness of Virtual Reality in Patients With Symptomatic Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272825
• Other study ID #: 2023-19/140
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: August 14, 2024

Study information

• Verified date: February 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Basak Cigdem Karacay, Asst Prof
• Phone: +9 0386 280 51 00.
• Email: basakcigdem[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 14, 2024
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain
• Quality of Life

Intervention

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.
• conventional rehabilitation
The conventional exercise program will include 20 minutes TENS with conventional method, 4 minutes continue ultrason, 20 minutes hot pack.

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University Faculty of Medicine	Kirsehir	City Center

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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