Digital Course and Precision Rehabilitation for Knee Osteoarthritis and Older Adults: Integration of Multisensory Stimulation and Digital Twin Technology
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
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Wei-Li Hsu, Ph.D.
- 電話番号：886-2-3366-8127
- メール：wlhsu@ntu.edu.tw
研究場所
-
-
-
Taipei、台湾
- まだ募集していません
- National Taiwan University Hospital
-
Taipei、台湾
- 募集
- Taipei Tzu Chi Hospital International Medical Service Center
-
Taipei、台湾
- まだ募集していません
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
(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.
Exclusion Criteria:
(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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Aim2: The experimental group will follow the digital rehabilitation exercise course combined with electrical stimulation or vibration for 12 weeks.
|
|
アクティブコンパレータ：Home exercises based on therapist education
Aim2: The control group will perform home exercises based on therapist education.
|
Aim2: The control group will perform home exercises based on therapist education for 12 weeks.
|
|
実験的：Gait retraining combined with neuromuscular electrical stimulation
Aim3: The experimental group will receive synchronized quadriceps electrical stimulation during gait training.
|
Aim3: The experimental group will receive synchronized quadriceps electrical stimulation during gait training for 15 minutes.
|
|
アクティブコンパレータ：Gait retraining
Aim3: The control group will receive gait retraining alone.
|
Aim3: The the control group will receive gait retraining alone for 15 minutes.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Visual Analog Scale
時間枠：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.
|
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.
|
|
Western Ontario and McMaster Universities Osteoarthritis Index
時間枠：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.
|
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.
|
|
Electromyographic Muscle Activity
時間枠：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.
|
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.
|
|
Biomechanical Motion Analysis
時間枠：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.
|
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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of Home-Based Exercise Combined with Electrical Stimulation
時間枠：Feasibility outcome measure will be assessed after completion of the 2-week home-based training program and will be reported through study completion.
|
The feasibility of performing home-based exercise combined with electrical stimulation will be assessed using feasibility-related questionnaires.
The assessment will focus on participants' experience, acceptability, and practicality of using electrical stimulation during home-based rehabilitation exercise.
|
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
時間枠：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.
|
Hemodynamic responses will be assessed using functional near-infrared spectroscopy.
The analysis will focus on quadriceps muscle hemodynamics and cerebral hemodynamics during functional tasks and multisensory stimulation.
Changes in hemodynamic parameters will be used to evaluate physiological responses associated with the intervention.
|
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
時間枠：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 extensor and flexor muscle strength will be assessed using maximal voluntary isometric contraction measured by a handheld dynamometer.
|
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
時間枠：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.
|
Knee joint proprioception will be assessed using inertial measurement sensors during a dynamic joint position sense test performed in a seated position.
The assessment will be used to quantify the accuracy of knee joint position control.
|
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
時間枠：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.
|
Functional movement performance will be assessed using the Five-Times Sit-to-Stand Test.
This test will be used to evaluate lower-extremity functional capacity and sit-to-stand performance.
|
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
時間枠：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.
|
Walking performance will be assessed using the 10-Meter Walk Test.
This test will be used to evaluate gait performance and walking ability in patients with knee osteoarthritis and healthy adults.
|
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
時間枠：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.
|
Functional mobility will be assessed using the Timed Up-and-Go Test.
This test will be used to evaluate dynamic balance, mobility, and functional movement capacity.
|
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
時間枠：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.
|
Weight-bearing knee flexion will be assessed during functional movement tasks.
This outcome will be used to evaluate knee movement control and functional knee flexion capacity under weight-bearing conditions.
|
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
時間枠：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.
|
Body composition will be assessed using InBody based on segmental multi-frequency bioelectrical impedance analysis.
Outcome variables will include body fat percentage, skeletal muscle mass, body weight, and body mass index.
|
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
時間枠：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.
|
Knee joint structure will be assessed using ultrasound imaging.
The assessment will include femoral cartilage thickness, suprapatellar bursa effusion, and meniscal extrusion, which are structural indicators related to knee osteoarthritis status.
|
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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202504020DINB
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。