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NCT Number: NCT06272825

Virtual Reality in Patients With 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Quality of Life Rheumatic Diseases Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Basak Cigdem Karacay, Asist Prof

CONTACT

[email protected]

0905445094803

Basak Cigdem Karacay, Asist Prof

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Visual Analog Scale

    Time frame: 7th 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.

  4. 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.

  5. 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.

  6. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 7th 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.

  7. 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.

  8. 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.

  9. Biodex Balance System

    Time frame: 7th 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Short Form 36 (SF36)

    Time frame: 7th 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Basak Cigdem Karacay, Asst Prof

CONTACT

[email protected]

+9 0386 280 51 00.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

Effectiveness of Virtual Reality in Patients With Symptomatic Knee Osteoarthritis

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 22, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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