Study on the Relationship Between Knee Osteoarthritis, Motor Control and the Risk of Falls, and the Effectiveness of Virtual Reality in Managing It in Older People
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Knee osteoarthritis symptoms
研究概览
简要总结
The goal of this clinical trial is to learn about knee osteoarthritis, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:
- What are the characteristics of a community-dwelling population over 60 years and older in terms of knee osteoarthritis, functionality, and risk of falls?
- Does an intervention with virtual reality lower knee osteoarthritis symptoms, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group receiving conventional physiotherapy treatment based on therapeutic exercise?
Participants will:
- Answer questionnaires.
- Perform physical laboratory tests through a camera-based motion capture system.
- Execute task-based exercises in a virtual environment through virtual reality.
Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older receiving conventional physiotherapy treatment based on therapeutic exercise to see if virtual reality improves knee osteoarthritis symptoms, functionality, and lowers fall risk.
详细描述
Background
Knee osteoarthritis (OA) is prevalent among older adults, affecting a substantial proportion of this population and being linked to various functional impairments such as joint stiffness, reduced mobility, and chronic pain. More specifically, knee OA is one of the most disabling musculoskeletal conditions worldwide, leading to significant healthcare costs and economic burdens. Several studies have demonstrated a strong association between knee OA and falls in older adults. In particular, it has been observed that knee OA is a significant predictor of multiple falls and is closely related to deficits in balance and gait stability.
To properly understand the close relationship between knee OA and falls, it is crucial to consider motor control dysfunctions associated with joint pain and mechanical alterations, as they are often the primary triggers of falls. Research in this field highlights the importance of directing new studies toward functional tasks, as they represent the essence of motor control. Therefore, the observation and analysis of functional tasks are crucial for examining the motor control of older adults, being 3D motion capture systems the gold standard for the measurement and analysis of human movement.
On the other hand, new technologies such as immersive virtual reality (VR) are gaining recognition and popularity as treatment modalities. This is because they allow users to interact with environments and situations that simulate real life, offering activities tailored to their needs while avoiding the potential risks of the real world. Additionally, it provides an opportunity to repeat exercises, improve performance, and achieve effective learning.
Objectives Several objectives are outlined, as a comprehensive approach involving two different phases will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 60 years.
- •Non-institutionalized individuals.
- •Subjects who wish and consent through informed consent to participate in the study.
- •Have the ability to walk independently (with or without assistive devices).
- •Diagnosis of primary knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology.
- •Specifically, for phase 1, subjects without a knee osteoarthritis diagnosis will also be included.
排除标准
- •History of significant previous traumas or surgeries to the spine, pelvis, or legs in the last 12 months.
- •Self-reported presence of dizziness, seizures, or epilepsy, aiming to prevent potential exacerbation of symptoms with VR.
- •Vestibular disorders (balance).
- •Neurological diseases, cardiovascular, or respiratory disorders affecting activity; as well as inflammatory or autoimmune diseases affecting the lower limb joints, and other forms of secondary osteoarthritis.
- •Diagnosis of a terminal illness or a health condition that prevents attendance.
- •To have a medical contraindication for exercise.
- •Body Mass Index (BMI) ≥ 40
结局指标
主要结局
Knee osteoarthritis symptoms
时间窗: Baseline and change from baseline at 7th week and at 12th month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire with 24 items divided into three subscales: (i) pain while walking, using stairs, in bed, sitting, lying down, and standing; (ii) stiffness after waking up and later in the day; (iii) physical function during activities like using stairs, rising from a seated position, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, and performing household tasks. Items are rated on a 0-4 scale: None (0), Mild (1), Moderate (2), Severe (3), Extreme (4). Scores are summed for each subscale (pain: 0-20, stiffness: 0-8, physical function: 0-68). The total score reflects greater pain, stiffness, and functional limitations with higher values.
Pain Intensity
时间窗: Baseline and change from baseline at 7th week and at 12th month
Visual Analog Scale (VAS) with a score ranging from 0 to 100 millimeters (mm).
Initial positioning
时间窗: Baseline and change from baseline at 7th week and at 12th month
Initial positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% greater than the average of the first 20 data points.
Final positioning
时间窗: Baseline and change from baseline at 7th week and at 12th month
Final positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% lower than the average of the first 20 data points.
Angular velocity
时间窗: Baseline and change from baseline at 7th week and at 12th month
Angular velocity of the spine and limbs through the 3D motion capture system Optitrack, determined from the slope of calculated linear regressions for the frames identified from the start to the peak of a movement, measured in degrees per second (°/s).
Acceleration
时间窗: Baseline and change from baseline at 7th week and at 12th month
Acceleration of the spine and limbs through the 3D motion capture system Optitrack, defined as the velocity of the spine and limbs change over time in meters per second square (m/s²).
Movement execution time
时间窗: Baseline and change from baseline at 7th week and at 12th month
Movement execution time of the spine and limbs through the 3D motion capture system Optitrack, defined as time in seconds to complete or initiate a task.
Range of joint movement
时间窗: Baseline and change from baseline at 7th week and at 12th month
Range of joint movement of the spine and limbs through the 3D motion capture system Optitrack, defined as the angle in degrees (°) between the initial and final positions of the spine and limb movements; two 3D vectors defined by the markers to calculate the arctangent.
次要结局
- Kinesiophobia(Baseline)
- Falls history(Baseline and change from baseline at 12th month)
- General health status(Baseline and change from baseline at 7th week and at 12th month)
- Date of birth(Baseline)
- Gender(Baseline)
- Height(Baseline)
- Weight(Baseline)
- Body mass index (BMI)(Baseline)
- Depressive symptoms(Baseline and change from baseline at 7th week and at 12th month)
- Cognitive capacity(Baseline and change from baseline at 7th week and at 12th month)
- Amount and type of medication consumed(Baseline and change from baseline at 7th week and at 12th month)
- Existence of comorbidity(Baseline)
- Physical performance and fall risk(Baseline and change from baseline at 7th week and at 12th month)
- Lower limb strength and function(Baseline and change from baseline at 7th week and at 12th month)
- Mobility and balance(Baseline and change from baseline at 7th week and at 12th month)
- Muscle Strength(Baseline and change from baseline at 7th week and at 12th month)
- Aerobic capacity(Baseline and change from baseline at 7th week and at 12th month)
- Heart Rate(Baseline and change from baseline at 7th week and at 12th month)
- Blood Pressure(Baseline and change from baseline at 7th week and at 12th month)
- Oxygen Saturation(Baseline and change from baseline at 7th week and at 12th month)
- Cibersickness(Baseline and change from baseline at 7th week and at 12th month)