Digital Course and Precision Rehabilitation for Knee Osteoarthritis and Older Adults: Integration of Multisensory Stimulation and Digital Twin Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Pain Visual Analog Scale
研究概览
简要总结
Knee osteoarthritis (OA) is a common degenerative joint disease in middle-aged and older adults and is frequently associated with pain, quadriceps weakness, reduced mobility, impaired proprioception, balance deficits, and limitations in daily functional activities. Exercise therapy is recommended as a first-line conservative treatment for early to moderate knee OA; however, conventional rehabilitation programs often rely on therapist supervision and lack objective, quantitative movement monitoring, real-time feedback, and personalized adjustment for home-based training. These limitations may reduce exercise adherence and make it difficult to ensure correct movement execution outside the clinical setting.
The overall aim of this study is to develop and evaluate a digital rehabilitation exercise program and user interface for individuals with arthritis, using a smart elastic knee brace integrated with wearable sensing technology, surface electromyography biofeedback, joint-angle monitoring, multisensory stimulation, and artificial intelligence-based musculoskeletal monitoring. The proposed system is designed to provide personalized digital rehabilitation courses, real-time visual and auditory feedback, and objective assessment of movement performance to support knee joint motor control, gait retraining, and individualized rehabilitation planning for patients with knee OA.
The investigators hypothesize that digital rehabilitation courses combined with multisensory stimulation, including neuromuscular electrical stimulation and vibration, will improve functional performance, movement quality, muscle activation, proprioception, and knee-related symptoms in patients with knee OA compared with conventional home exercise or gait retraining alone. The expected outcome of this study is to establish the feasibility, reliability, and clinical utility of a smart knee brace-based digital rehabilitation system for personalized knee OA management.
This study will achieve the following four specific aims:
Aim 1: To determine the feasibility of home-based exercise combined with electrical stimulation and the reliability of digital assessment for tracking exercise performance.
Patients with knee OA and healthy adults will be recruited to complete selected quadriceps strengthening exercises based on exercise difficulty levels. Participants will perform a two-week home-based training program using exercise combined with electrical stimulation. Feasibility will be assessed using questionnaires, and movement performance will be tracked using inertial sensors during functional tasks. This aim will provide evidence regarding the practicality of integrating electrical stimulation into home-based rehabilitation and the reliability of digital monitoring for exercise performance.
Aim 2: To evaluate the effects of digital rehabilitation exercise courses combined with multisensory stimulation in patients with knee OA and healthy adults.
Participants will be randomly assigned to an experimental group or a control group. Both groups will complete a twelve-week home exercise program, three times per week for 40 minutes per session. The experimental group will follow the digital rehabilitation exercise course combined with electrical stimulation or vibration, whereas the control group will perform home exercises based on therapist education. Outcomes will be assessed at four time points: before training, after eight weeks of training, after twelve weeks of training, and six weeks after the intervention. Assessments will include pain, WOMAC scores, hemodynamic responses, muscle strength, electromyographic activity, proprioception, functional performance, body composition, knee structure, and biomechanical parameters.
Aim 3: To determine the immediate effects of gait retraining combined with neuromuscular electrical stimulation in patients with knee OA.
Patients with knee OA will be randomly assigned to either a gait retraining group or a gait retraining combined with neuromuscular electrical stimulation group. Both groups will receive a single 15-minute gait retraining intervention focused on modifying the foot progression angle. The experimental group will receive synchronized quadriceps electrical stimulation during gait training, while the control group will receive gait retraining alone. Pre- and post-intervention assessments will be performed to examine the immediate effects on gait parameters and functional movement performance.
Aim 4: To develop and validate a personalized knee joint digital twin model using artificial intelligence, multisensory stimulation, and wearable sensing technology.
This aim will develop an AI-based musculoskeletal monitoring system that integrates wearable sensor data, functional movement analysis, and personalized knee joint modeling. Patients with knee OA and healthy adults will perform functional tasks such as squatting, stair stepping, and walking under different stimulation conditions, including conti
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Group A: Healthy Adults)
- •Participants aged 20 to 80 years.
- •Participants who have no knee discomfort symptoms, such as knee pain or muscle weakness.
- •(Group B: Patients with Knee Osteoarthritis)
- •Participants aged 50 to 80 years.
- •Patients diagnosed with knee osteoarthritis, classified as Kellgren-Lawrence grade 1 to grade 3.
排除标准
- •(Group A and B)
- •History of knee or hip surgery.
- •Systemic arthritis.
- •Neurological disease.
- •Malignant tumor.
- •Untreated osteomyelitis or immature skeletal development.
- •Pregnancy.
- •Inflammatory ulcer.
- •Deep vein thrombosis.
- •Excessively moist wounds.
- •Hemophilia.
- •Local infection in the treatment or assessment area.
- •Acute myocardial infarction.
- •Unstable angina.
- •Severe aortic stenosis.
- •Uncontrolled heart failure.
- •Acute pulmonary embolism.
- •Acute myocarditis or pericarditis.
- •Acute aortic dissection.
研究组 & 干预措施
Digital rehabilitation exercise courses combined with multisensory stimulation
Aim2: The experimental group will follow the digital rehabilitation exercise course combined with electrical stimulation or vibration.
干预措施: digital rehabilitation exercise courses combined with multisensory stimulation (Device)
Home exercises based on therapist education
Aim2: The control group will perform home exercises based on therapist education.
干预措施: Home exercises based on therapist education (Device)
Gait retraining combined with neuromuscular electrical stimulation
Aim3: The experimental group will receive synchronized quadriceps electrical stimulation during gait training.
干预措施: Gait retraining combined with neuromuscular electrical stimulation (Device)
Gait retraining
Aim3: The control group will receive gait retraining alone.
干预措施: Gait retraining (Device)
结局指标
主要结局
Pain Visual Analog Scale
时间窗: Pain Visual Analog Scale outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.
Pain intensity will be assessed using the Visual Analog Scale. Participants will be asked to report their knee pain level before and after the intervention to evaluate changes in pain symptoms associated with the digital rehabilitation exercise program, multisensory stimulation, or gait retraining intervention.
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: WOMAC outcome measure will be assessed before training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.
Knee symptoms and functional limitations will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The questionnaire will be used to evaluate knee-related pain, stiffness, and physical function in patients with knee osteoarthritis.
Electromyographic Muscle Activity
时间窗: Electromyographic muscle activity outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.
Muscle activity will be assessed using surface electromyography. Electrodes will be placed on the quadriceps and hamstring muscles to evaluate muscle activation patterns during functional movement tasks and exercise intervention.
Biomechanical Motion Analysis
时间窗: Biomechanical motion analysis outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.
Biomechanical movement parameters will be assessed using OpenCap markerless motion capture system and inertial measurement sensors. Joint angles, joint velocities, and related kinematic parameters will be analyzed during functional movement tasks. Force plate data will also be used to assess joint moments when applicable.
次要结局
- Feasibility of Home-Based Exercise Combined with Electrical Stimulation(Feasibility outcome measure will be assessed after completion of the 2-week home-based training program and will be reported through study completion.)
- Hemodynamics Analysis(Hemodynamics outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Knee Muscle Strength(Knee muscle strength outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Knee Joint Proprioception(Knee joint proprioception outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Five-Times Sit-to-Stand Test(Five-Times Sit-to-Stand Test outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- 10-Meter Walk Test(Ten-Meter Walk Test outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Timed Up-and-Go Test(Timed Up-and-Go Test outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Weight-Bearing Knee Flexion(Weight-bearing knee flexion outcome measure will be assessed before training, after 15 minutes of training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Body Composition(Body composition outcome measure will be assessed before training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)
- Ultrasound Assessment of Knee Joint Structure(Ultrasound assessment outcome measure will be assessed before training, after 8 weeks of training, after 12 weeks of training, and 6 weeks after the intervention, and will be reported through study completion.)