Virtual Reality in Patients With Knee Osteoarthritis

NCT06272825 | Recruiting

• 1 other identifier: 2023-19/140
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Pain; Quality of Life

Keywords

Knee Osteoarthritis; virtual reaility; pain; Quality of Life

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Short Form 36 (SF36)

  Baseline

• Short Form 36 (SF36)

  3th week

• Short Form 36 (SF36)

  7th week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Other: conventional rehabilitation

Control group

ACTIVE COMPARATOR

The conventional rehabilitation program at the hospital will be implemented in 15 sessions, 5 days a week.

Other: conventional rehabilitation

Interventions

Virtual reality OTHER

VR-based exercise program will be applied in addition to the conventional rehabilitation program, 5 days a week for a total of 3 weeks.

Experimental Group

conventional rehabilitation OTHER

The conventional exercise program will include 20 minutes(Transcutaneous Electrical Nerve Stimulation) TENS with conventional method, 4 minutes continue ultrason, 20 minutes hot pack.

Control group; Experimental Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 31981832 BACKGROUND

• 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.

  PMID: 32985509 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Basak Cigdem Karacay, Asst Prof

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem Karacay, Asst Prof

CONTACT

+9 0386 280 51 00.; basakcigdem@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcomes Assessor will be different persons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: May 28, 2024
• Primary Completion: December 14, 2024
• Study Completion: January 14, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

TU (1)