The Investigation of the Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability Around the Knee and Balance in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Muscle Excitability
研究概览
简要总结
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:
- Are non-immersive virtual reality-based knee exercises effective on muscle excitability around the knee and balance in patients with knee osteoarthritis?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Muscle Excitability
时间窗: Change from baseline muscle excitability at week 3.
Electromyography will be used to evaluate muscle excitability. Superficial electrodes will be used for assessments, no needle electrodes will be used. EMG or ENMG (electroneuromyography); It is expressed by the abbreviation of the terms electro (electrical), neuro (nerve), myo (muscle) and graphy (writing). Electromyography is a test used to measure the natural electrical activity of muscles. It can be determined that the disease, which is evaluated by EMG, originates from the muscle or nervous system. During the EMG process, the signals coming from the muscles and nerves are transferred to the digital environment as data through a special device and electrodes. The data in the digital environment are interpreted by neurologists and it is evaluated whether there is any abnormality. EMG is divided into two applications: surface EMG, where the electrodes are attached to the skin, and needle EMG, where the needle electrode is inserted into the muscle.
Static Balance
时间窗: Change from baseline static balance at week 3.
The Tetrax® Interactive Static Posturography System (Tetrax°) (Sunlight Medical Ltd, Israel) will be used to assess static balance. It is a computerized posturography measuring device that is frequently used in the measurement of static balance. A total of 8 different measurements are made, with eyes open and closed. Eight different postures are evaluated for the test, and each posture is measured for 32 seconds. Initial stance, head up, eyes open (NO), then head upright, eyes closed (NC) stance is evaluated to limit visual impact; thereby emphasizing the influence of the somatic sense or vestibular organ. Next, four different postures are tested in the following order: head to the right (HR), head turned 45° to the right; head left (HL), head turned 45° left; Measurements are completed with the head back (HB), tilting the head back 30° and facing the ceiling, and forward (HF), tilting the head forward 30° and facing the floor.
次要结局
- Patient Satisfaction from Treatment(At week 3.)
- Knee Proprioception(Change from baseline knee proprioception at week 3.)
- Dynamic Balance(Change from baseline Dynamic Balance at week 3.)
- Physical Function Level(Change from baseline Physical Function Level at week 3.)
- Muscle Endurance(Change from baseline Endurance at week 3.)
- Independence in Activities of Daily Living(Change from baseline Independence in Activities of Daily Living at week 3.)
研究者
Mehmet Sönmez
Lecturer
Erzurum Technical University