Clinical trial NCT06616896: Precision Rehabilitation: Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
Official title: Precision Rehabilitation: Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Knee or hip surgery
* Systemic arthritis
* Neurological disorders.

Primary outcomes:
measure: muscle strength
timeFrame: Muscle strength outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
measure: Muscle activity
timeFrame: Muscle activity outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
measure: Proprioception
timeFrame: Proprioception outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
measure: Hemodynamics analysis of Oxygenated Hemoglobin
timeFrame: Oxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
measure: Hemodynamics analysis of Deoxygenated Hemoglobin
timeFrame: Deoxygenated Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
measure: Hemodynamics analysis of Total Hemoglobin
timeFrame: Total Hemoglobin outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Secondary outcomes:
measure: Five-sit-to-stand tests(5-STS)
timeFrame: 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
measure: Time up and go test (TUG)
timeFrame: 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
measure: 10-meter walking test
timeFrame: 10-meter walking test outcome measure will be assessed immediately after vibration and will be reported through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital International Medical Service Center
Study officials:
References: