Clinical trial NCT05595317: The Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability in Knee Osteoarthritis
Official title: The Investigation of the Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability Around the Knee and Balance in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Virtual Reality
Keywords: Balance
Muscle excitability
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Study group will take Non-immersive Virtual reality (VR) exercise, sham controlled group will take sham VR.
Primary purpose: TREATMENT

Brief summary: The main goal of this sham-controlled clinical trial is to learn the excitability levels of the muscles around the knee and balance using objective measurement methods in patients with knee osteoarthritis of non-immersive virtual reality application. The secondary aims of the study are to investigate in which direction the proprioception, physical function level, independence level in activities of daily living, muscle endurance around the knee and patient satisfaction change with non-immersive virtual reality application in patients with knee osteoarthritis. In this study, main questions are to answer:

1. Are non-immersive virtual reality-based knee exercises effective on muscle excitability around the knee and balance in patients with knee osteoarthritis?
2. Are non-immersive virtual reality-based knee exercises effective in improving the level of physical function in patients with knee osteoarthritis?

The data collection part of this study will be carried out on volunteers, male and female, who have been diagnosed with knee osteoarthritis by a Physical Medicine and Rehabilitation specialist at Erzurum Atatürk University Training and Research Hospital. After informing the participants about the study, the consent form will be signed. Participants will be patients receiving routine outpatient physical therapy. The study was planned as a randomized controlled trial with a sham-control group.

The study group will receive non-immersive virtual reality in addition to traditional physiotherapy, and the control group will receive sham virtual reality exercise in addition to traditional physiotherapy.

Detailed description: Estimated Forty-four volunteer participants with knee osteoarthritis over 18 years who will be at stage of 1-3 according to the Kellgren Lawrence radiological evaluation will be included in the study. The groups will be formed by computerized randomization method after stratification based on gender and knee osteoarthritis severity.

The study group will receive 45 minutes of traditional physiotherapy a day, 5 days a week for 3 weeks, plus 30 minutes of non-immersive virtual reality-based knee joint exercises. The sham-control group will receive 45 minutes of traditional physiotherapy a day, 5 days a week for 3 weeks and 30 minutes of sham non-immersive virtual reality practice.

Demographic data will be evaluated by Demographic Information Form, muscle excitability will be evaluated by superficial Electromyography (EMG) and static balance will be evaluated by Tetrax posturography device. Knee joint proprioception sensation will be achieved with the Protractor and Angle Gauge (Toolkit, Korea) application. Physical function assessment with Western Ontario and McMaster Universities Arthritis Index (WOMAC), independence level with Katz Activities of Daily Living Independence Index, muscular endurance with 30-second stand-up test (30 Seconds Chair Stand Test), dynamic balance with Timed Up and Go test, Participants' satisfaction with the treatment they receive will be evaluated with a 10-centimeter Visual Analogue Scale (VAS). Measurements will be performed at baseline and at the end of the 3rd week of treatment as post-intervention.

Eligibility criteria: Inclusion Criteria:

* Those over the age of 18
* Those with a Kellgren and Lawrence score between 1-3
* Those who can walk \> 15 m independently
* Those who agreed to participate in the study.

Exclusion Criteria:

* Those with knee osteoarthritis with any contagious infection, autoimmune disease or fracture
* Those with a history of malignancy, dizziness, vertigo or stroke that may affect posture and balance, or a history of underlying neurological and vestibular disease
* Those who have undergone any knee operation
* Those receiving injection therapy for knee OA

Primary outcomes:
measure: Muscle Excitability
timeFrame: Change from baseline muscle excitability at week 3.
measure: Static Balance
timeFrame: Change from baseline static balance at week 3.
Secondary outcomes:
measure: Knee Proprioception
timeFrame: Change from baseline knee proprioception at week 3.
measure: Physical Function Level
timeFrame: Change from baseline Physical Function Level at week 3.
measure: Independence in Activities of Daily Living
timeFrame: Change from baseline Independence in Activities of Daily Living at week 3.
measure: Muscle Endurance
timeFrame: Change from baseline Endurance at week 3.
measure: Dynamic Balance
timeFrame: Change from baseline Dynamic Balance at week 3.
measure: Patient Satisfaction from Treatment
timeFrame: At week 3.
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
affiliation: Abant Izzet Baysal University
name: Şebnem AVCI, PhD
role: STUDY_DIRECTOR
References: