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Knee OsteoarthristisNCT07695168

Digital Course and Precision Rehabilitation for Knee Osteoarthritis and Older Adults: Integration of Multisensory Stimulation and Digital Twin Technology

A study testing digital rehabilitation exercise courses combined with multisensory stimulation, Home exercises based on therapist education and Gait retraining combined with neuromuscular electrical stimulation in people with Knee Osteoarthristis and Healthy Adults, run by National Taiwan University Hospital at 3 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthristis, Healthy Adults
What is being tested?
digital rehabilitation exercise courses combined with multisensory stimulation, Home exercises based on therapist education and Gait retraining combined with neuromuscular electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesTaiwan
Study dates
1 Jul 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (Group A and B)
  • History of knee or hip surgery.
  • Systemic arthritis.
  • Neurological disease.
  • Malignant tumor.
  • Untreated osteomyelitis or immature skeletal development.
Show all 19Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wei-Li Hsu, Ph.D. contact

886-2-3366-8127

wlhsu@ntu.edu.tw

Taiwan3 sites, 3 recruiting
  • National Taiwan University Hospital

    Taipei

    Not yet recruiting
  • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

    Taipei

    Not yet recruiting
  • Taipei Tzu Chi Hospital International Medical Service Center

    Taipei

    Recruiting

Other trials in Taiwan

About this study

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.

Read more

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

Being tested
digital rehabilitation exercise courses combined with multisensory stimulation, Home exercises based on therapist education, Gait retraining combined with neuromuscular electrical stimulation, Gait retraining

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • digital rehabilitation exercise courses combined with multisensory stimulationDevice

    Aim2: The experimental group will follow the digital rehabilitation exercise course combined with electrical stimulation or vibration for 12 weeks.

  • Home exercises based on therapist educationDevice

    Aim2: The control group will perform home exercises based on therapist education for 12 weeks.

  • Gait retraining combined with neuromuscular electrical stimulationDevice

    Aim3: The experimental group will receive synchronized quadriceps electrical stimulation during gait training for 15 minutes.

  • Gait retrainingDevice

    Aim3: The the control group will receive gait retraining alone for 15 minutes.

Study groups in NCT07695168
Study groupRoleWhat they receive
Digital rehabilitation exercise courses combined with multisensory stimulationExperimentalAim2: The experimental group will follow the digital rehabilitation exercise course combined with electrical stimulation or vibration.
Receives: Device: digital rehabilitation exercise courses combined with multisensory stimulation
Home exercises based on therapist educationActive comparatorAim2: The control group will perform home exercises based on therapist education.
Receives: Device: Home exercises based on therapist education
Gait retraining combined with neuromuscular electrical stimulationExperimentalAim3: The experimental group will receive synchronized quadriceps electrical stimulation during gait training.
Receives: Device: Gait retraining combined with neuromuscular electrical stimulation
Gait retrainingActive comparatorAim3: The control group will receive gait retraining alone.
Receives: Device: Gait retraining

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Visual Analog Scale

    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.

    Measured: 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.

  2. Western Ontario and McMaster Universities Osteoarthritis Index

    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.

    Measured: 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.

  3. Electromyographic Muscle Activity

    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.

    Measured: 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.

  4. Biomechanical Motion Analysis

    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.

    Measured: 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.

Secondary outcomes (10)
  1. Feasibility of Home-Based Exercise Combined with Electrical Stimulation

    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.

    Measured: Feasibility outcome measure will be assessed after completion of the 2-week home-based training program and will be reported through study completion.

  2. Hemodynamics Analysis

    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.

    Measured: 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.

  3. Knee Muscle Strength

    Knee extensor and flexor muscle strength will be assessed using maximal voluntary isometric contraction measured by a handheld dynamometer.

    Measured: 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.

  4. Knee Joint Proprioception

    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.

    Measured: 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.

  5. Five-Times Sit-to-Stand Test

    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.

    Measured: 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.

  6. 10-Meter Walk Test

    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.

    Measured: 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.

  7. Timed Up-and-Go Test

    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.

    Measured: 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.

  8. Weight-Bearing Knee Flexion

    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.

    Measured: 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.

  9. Body Composition

    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.

    Measured: 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.

  10. Ultrasound Assessment of Knee Joint Structure

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07695168
Sponsor's protocol ID
202504020DINB
Status last verified
Jun 2026
First submitted
29 Jun 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing digital rehabilitation exercise courses combined with multisensory stimulation, Home exercises based on therapist education and Gait retraining combined with neuromuscular electrical stimulation in people with Knee Osteoarthristis and Healthy Adults, run by National Taiwan University Hospital at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei-Li Hsu, Ph.D. (886-2-3366-8127, wlhsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Visual Analog Scale (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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