Knee OsteoarthristisNCT06616896
Precision Rehabilitation: Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
A study testing vibration in people with Knee Osteoarthristis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Knee osteoarthritis (OA) is a common degenerative disease in older populations. Chronic pain, quadriceps weakness, limited daily activities, lack of mobility, and balance and walking dysfunction are the most common symptoms. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2024to 12 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 to 80 years
- A diagnosis of knee OA (Kellgren and Lawrence grade 1~3 on X-ray) according to the American College of Rheumatology's criteria.
Who cannot join
- Knee or hip surgery
- Systemic arthritis
- Neurological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital International Medical Service Center
Taipei
Lin, +886-0912873031, Shinelin0807@gmail.com
About this study
Knee osteoarthritis (OA) is a common degenerative disease in older populations. Chronic pain, quadriceps weakness, limited daily activities, lack of mobility, and balance and walking dysfunction are the most common symptoms. The overall aim of this study is to employ artificial intelligence (AI) based on the concepts of precision rehabilitation to design a wearable multifunctional vibration knee brace that is best suited for improving degenerative knee OA in functional performance and pain relief. The investigators hypothesize that this AI-based precision rehabilitation device will improve the functional performance and pain relief of elderly patients with degenerative knee OA compared to conventional treatments. The expected outcome of this proposed study will be evidence of the feasibility and efficacy of exercise training combined with vibration intervention using an AI knee brace in patients with knee OA. This four-year study will achieve the following three specific aims:
Aim 1: To identify the optimal mode of vibration intervention during functional movements in patients with knee OA.
Read more
Patients with knee OA will be recruited and receive different vibration conditions at the thigh muscles during functional movements. This cross-sectional, single-blind, randomized study will provide reference values based on the results of hemodynamics in the brain and the local muscles, as well as muscle strength tests to determine the best vibration intervention mode for patients with knee OA. The investigators will recruit 60 patients with knee OA and assess changes in hemodynamics, proprioception, functional performance, and muscle strength performance pre- and post-vibration. The optimized vibration intervention mode of this study will contribute to the reference foundation for vibration intervention in patients with knee OA, as well as the implementation decision-making of aims 2 and 3 of this study.
Aim 2: To develop an AI knee brace that can be used as a clinical evaluation tool and implement vibration intervention at the right time.
The investigators will develop an AI knee brace that can collect movement data, such as kinematics, kinetics, and muscle activities, as inputs. Then, it outputs computed data such as functional task recognition and joint force estimation. Using AI algorithms, the investigators will analyze the biomechanical data collected by the sensors embedded in the knee brace and adjust the vibration frequency, intensity, and duration to optimize the therapeutic effects. This study will recruit 10 patients with knee OA and 10 age-matched healthy elderly participants. The AI knee brace will be validated for its evaluation function and therapeutic effects.
Aim 3: To determine the effects of exercise training combined with vibration intervention using the AI knee brace in patients with knee OA.
The investigators used sealed letter to conduct a randomized control trial (RCT), using the developed AI knee brace in conjunction with exercise training to enhance functional performance and relieve pain in patients with knee OA. This exercise training can integrate real-time knee motion assistance and muscle activity feedback, which will help patients control the knee while exercising to avoid sports injuries. The 60 knee OA patients will be randomly assigned into two groups. The experimental group will receive a combined AI knee brace and exercise training intervention for 8 weeks, while the control group will receive standard exercise training alone. Hemodynamic and biomechanical analyses will determine the outcome at four-time points (i.e., pre-training, post-training, 3-month post-training, and 1-year post-training).
- Conditions
- Knee Osteoarthristis
- Being tested
- vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationDevice
Each participant will randomly receive four different vibration conditions (2 frequencies × 2 vibration modes = 4 conditions) in a different order. Considering that the current research range of local vibration frequency is 10 to 150 Hz the frequencies with low and high frequencies (30/60Hz) will be selected. The location chosen for this study is the quadriceps muscle belly. Two-minute vibrations will improve muscle strength without any fatigue side effects. Two vibration modes include providing a two-minute continuous vibration intervention and only providing vibration during the rest position before executing the functional test.
| Study group | Role | What they receive |
|---|---|---|
| Continued mode vibration intervention | Experimental | Not described Receives: Device: vibration |
| Pause mode vibration intervention | Experimental | Not described Receives: Device: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
muscle strength will be measured by maximal voluntary isometric contraction (MVIC) of the knee extension using a dynamometer muscle tester. All muscle strength data will be normalized with body weight.
Measured: Muscle strength outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Muscle activity
Muscle activity will be collected by electrography (EMG). Electrode sites (quadriceps) will be shaved and cleaned with alcohol to enhance signal quality. All electrodes were placed longitudinally over the muscle.
Measured: Muscle activity outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Proprioception
Knee joint position sense absolute error will be measured using Inertial Measurement Unit (IMU) before and after vibration intervention to evaluate proprioception. IMU is a device that measures and reports an object's specific force, angular rate, and sometimes magnetic field surrounding the body using a combination of sensors, including accelerometers, gyroscopes, and sometimes magnetometers.
Measured: Proprioception outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Oxygenated Hemoglobin
Hemodynamics analysis of Oxygenated Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Oxygenated Hemoglobin before and after vibration intervention.
Measured: Oxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Deoxygenated Hemoglobin
Hemodynamics analysis of Deoxygenated Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Deoxygenated Hemoglobin before and after vibration intervention.
Measured: Deoxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Total Hemoglobin
Hemodynamics analysis of Total Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Oxygenated Hemoglobin before and after vibration intervention.
Measured: Total Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Secondary outcomes (3)
Five-sit-to-stand tests(5-STS)
Functional movement assessment will be assessed through Five-sit-to-stand tests(5-STS)
Measured: Five-sit-to-stand tests(5-STS) outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Time up and go test (TUG)
Functional movement assessment will be assessed through Time up and go test (TUG)
Measured: Time up and go test (TUG) outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
10-meter walking test
Functional movement assessment will be assessed through 10-meter walking test
Measured: 10-meter walking test outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Oct 2024
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616896
- Sponsor's protocol ID
- 202404060RIND
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Rehabilitation: Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06616896
- Acronym / sponsor ID
- 202404060RIND
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis (OA) is a common degenerative disease in older populations. Chronic pain, quadriceps weakness, limited daily activities, lack of mobility, and balance and walking dysfunction are the most common symptoms. The overall aim of this study is to employ artificial intelligence (AI) based on the concepts of precision rehabilitation to design a wearable multifunctional vibration knee brace that is best suited for improving degenerative knee OA in functional performance and pain relief. The investigators hypothesize that this AI-based precision rehabilitation device will improve the functional performance and pain relief of elderly patients with degenerative knee OA compared to conventional treatments. The expected outcome of this proposed study will be evidence of the feasibility and efficacy of exercise training combined with vibration intervention using an AI knee brace in patients with knee OA. This four-year study will achieve the following three specific aims:
Aim 1: To identify the optimal mode of vibration intervention during functional movements in patients with knee OA.
Patients with knee OA will be recruited and receive different vibration conditions at the thigh muscles during functional movements. This cross-sectional, single-blind, randomized study will provide reference values based on the results of hemodynamics in the brain and the local muscles, as well as muscle strength tests to determine the best vibration intervention mode for patients with knee OA. The investigators will recruit 60 patients with knee OA and assess changes in hemodynamics, proprioception, functional performance, and muscle strength performance pre- and post-vibration. The optimized vibration intervention mode of this study will contribute to the reference foundation for vibration intervention in patients with knee OA, as well as the implementation decision-making of aims 2 and 3 of this study.
Aim 2: To develop an AI knee brace that can be used as a clinical evaluation tool and implement vibration intervention at the right time.
The investigators will develop an AI knee brace that can collect movement data, such as kinematics, kinetics, and muscle activities, as inputs. Then, it outputs computed data such as functional task recognition and joint force estimation. Using AI algorithms, the investigators will analyze the biomechanical data collected by the sensors embedded in the knee brace and adjust the vibration frequency, intensity, and duration to optimize the therapeutic effects. This study will recruit 10 patients with knee OA and 10 age-matched healthy elderly participants. The AI knee brace will be validated for its evaluation function and therapeutic effects.
Aim 3: To determine the effects of exercise training combined with vibration intervention using the AI knee brace in patients with knee OA.
The investigators used sealed letter to conduct a randomized control trial (RCT), using the developed AI knee brace in conjunction with exercise training to enhance functional performance and relieve pain in patients with knee OA. This exercise training can integrate real-time knee motion assistance and muscle activity feedback, which will help patients control the knee while exercising to avoid sports injuries. The 60 knee OA patients will be randomly assigned into two groups. The experimental group will receive a combined AI knee brace and exercise training intervention for 8 weeks, while the control group will receive standard exercise training alone. Hemodynamic and biomechanical analyses will determine the outcome at four-time points (i.e., pre-training, post-training, 3-month post-training, and 1-year post-training).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued mode vibration intervention | Experimental | Device: vibration |
| Pause mode vibration intervention | Experimental | Device: vibration |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 50 to 80 years
- A diagnosis of knee OA (Kellgren and Lawrence grade 1~3 on X-ray) according to the American College of Rheumatology's criteria.
Key exclusion criteria (3 listed)
- Knee or hip surgery
- Systemic arthritis
- Neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibrationEach participant will randomly receive four different vibration conditions (2 frequencies × 2 vibration modes = 4 conditions) in a different order. Considering that the current research range of local vibration frequency is 10 to 150 Hz the frequencies with low and high frequencies (30/60Hz) will be selected. The location chosen for this study is the quadriceps muscle belly. Two-minute vibrations will improve muscle strength without any fatigue side effects. Two vibration modes include providing a two-minute continuous vibration intervention and only providing vibration during the rest position before executing the functional test. | Device | Continued mode vibration intervention, Pause mode vibration intervention |
Primary outcome
muscle strength
Time frame: Muscle strength outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
muscle strength will be measured by maximal voluntary isometric contraction (MVIC) of the knee extension using a dynamometer muscle tester. All muscle strength data will be normalized with body weight.
Muscle activity
Time frame: Muscle activity outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Muscle activity will be collected by electrography (EMG). Electrode sites (quadriceps) will be shaved and cleaned with alcohol to enhance signal quality. All electrodes were placed longitudinally over the muscle.
Proprioception
Time frame: Proprioception outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Knee joint position sense absolute error will be measured using Inertial Measurement Unit (IMU) before and after vibration intervention to evaluate proprioception. IMU is a device that measures and reports an object's specific force, angular rate, and sometimes magnetic field surrounding the body using a combination of sensors, including accelerometers, gyroscopes, and sometimes magnetometers.
Hemodynamics analysis of Oxygenated Hemoglobin
Time frame: Oxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Oxygenated Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Oxygenated Hemoglobin before and after vibration intervention.
Hemodynamics analysis of Deoxygenated Hemoglobin
Time frame: Deoxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Deoxygenated Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Deoxygenated Hemoglobin before and after vibration intervention.
Hemodynamics analysis of Total Hemoglobin
Time frame: Total Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Hemodynamics analysis of Total Hemoglobin will focus on quadriceps muscles and cerebral hemodynamics data and will be monitored simultaneously using fNIRS during vibration. The areas of interest in cerebral hemodynamics mainly focus on the dorsal medial prefrontal cortex (DMPFC) because DMPFC plays an essential role in rapid error prediction. The investigators will conduct data analysis by comparing the changes in parameters of Oxygenated Hemoglobin before and after vibration intervention.
3 secondary outcomes
Five-sit-to-stand tests(5-STS)
Time frame: Five-sit-to-stand tests(5-STS) outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Time up and go test (TUG)
Time frame: Time up and go test (TUG) outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
10-meter walking test
Time frame: 10-meter walking test outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibration in people with Knee Osteoarthristis, run by National Taiwan University Hospital at 1 site 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 2 inclusion and 3 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
muscle strength (time frame: Muscle strength outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year). The study lists 6 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 21 May 2025.