Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616896
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Precision Rehabilitation Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Rehabilitation Mechanisms and Efficacy of Vibration in Exercise Training for Degenerative Knee Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3 vibration conditions at the thigh muscles with low frequency or high frequency 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 ie pre-training post-training 3-month post-training and 1-year post-training
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 3 vibration conditions at the thigh muscles with low frequency or high frequency 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 ie pre-training post-training 3-month post-training and 1-year post-training
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None