Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain

Study Overview
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Brief Summary
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The study will be a 12-week randomized controlled trial that aims to examine the effects of a machine learning-based lower limb exercise training system for older adults with knee pain. Participants will be randomly allocated to either the machine learning-based lower limb exercise training system group (intervention arm), video-based exercise training system group (intervention arm), or usual care group (control arm). Data will be collected at baseline, and at 4, 8, and 12 weeks after randomization.

Detailed Description
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Knee pain, often caused by osteoarthritis, is a prevalent musculoskeletal disorder among older adults and significantly reduces physical function and quality of life. Exercise therapy has been shown to be an effective form of treatment for knee pain. However, the traditional delivery of exercise therapy requires that individuals attend clinics to participate in face-to-face exercise sessions, which can be expensive and inconvenient. In recent years, information technologies have been used to support the delivery of exercise programs. The programs have also shown great benefits in improving the management of knee pain. However, it remains a concern that physical therapists are not able to provide the patients with direct and immediate supervision when exercises are taken place remotely at home or in community centers, which can be detrimental to exercise performance and the management of knee pain. Thus, the research team has developed a machine learning-based exercise training system to provide evidence-based lower limb exercise videos, real-time movement feedback, and tracking of exercise progress for older adults with knee pain. In this study, a proof-of-concept randomized controlled trial will be conducted to examine the effects of the machine learning-based exercise training system, comparing with the effects of video-based exercise training system (providing exercise videos alone but no real-time movement feedback or tracking of exercise progress) and effects of usual care.

Official Title
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Effects of a Machine Learning-based Lower Limb Exercise Training System for Older Adults With Knee Pain: A Proof-of-concept Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Device: Machine learning-based exercise training system
* Device: Video-based exercise training system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be recruited if they age ≥ 55 years, have knee pain, stiffness, or both in one or both knees on most days for at least one month during the past 12 months, or have consulted healthcare professionals with their pain, stiffness, or both in one or both knees during the past 12 months, are able to perform the exercises required in physical assessments and exercise training, are able to speak and read Chinese, are able to provide written informed consent. Exclusion Criteria: Individuals will be excluded if they have inflammatory arthritis, acute trauma, malignancy, history of knee replacement, being on the waiting list for knee surgery, physical therapy for knee problems during the past three months, intra-articular injection to the knee within six months.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Machine learning-based exercise training system<br>Participants will join 6 individual exercise sessions (i.e., 20 minutes each session, once every two weeks) in our lab. During the exercise sessions, they will use the machine learning-based exercise training system to perform lower limb exercises. In addition, participants will receive an educational booklet on knee pain management. They will be encouraged to perform exercises at home at least 3 times per week over a 12-week period. | Device: Machine learning-based exercise training system<br>* The video-based exercise training system will have three key features: Evidence-based exercise videos instructed by physical therapists Real-time movement feedback and performance score Exercise records.<br>|
| Experimental: Video-based exercise training system<br>Participants will join 6 individual exercise sessions (i.e., 20 minutes each session, once every two weeks) in our lab. During the exercise sessions, they will use the video-based exercise training system to perform lower limb exercises. In addition, participants will receive an educational booklet on knee pain management. They will be encouraged to perform exercises at home at least 3 times per week over a 12-week period. | Device: Video-based exercise training system<br>* The video-based system will only include the exercise videos as those involved in the machine learning-based system. The features of real-time movement feedback and tracking of exercise progress will not be provided.<br>|
| No Intervention: Usual care<br>Participants will receive the same educational booklet as the other groups. They will be encouraged to perform exercises at home at least 3 times per week over a 12-week period. No other intervention will be provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in knee pain as assessed by the 5-item pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The items will be rated on a 5-point Likert scale which corresponds to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in physical function as assessed by the 17-item physical function subscale of WOMAC | The items will be rated on a 5-point Likert scale which corresponds to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). | from baseline to 4 weeks, 8 weeks, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of knee pain over the previous 7 days as assessed by an 11-point numerical rating scale | 0 represents no pain and 10 represents the worst possible pain. | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in physical function as assessed by 30-second chair-stand test |  | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in physical function as assessed by 40 m fast-paced walk test |  | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in physical function as assessed by timed up-and-go test |  | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in severity rating of patient nominated main functional problems over the previous 3 days | At baseline, participants will select three activities that they perform frequently, which they perceive as important in their life, and which knee pain makes difficult for them. The severity of each functional problem will be rated on an 11-point scale, with 0 representing unable to perform the activity and 10 representing able to perform the activity at the same level as before the presence of knee pain. | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in self-efficacy as assessed by the 8-item Arthritis Self-efficacy Scale | Each item will be rated on a scale with response categories ranging from 1 (very uncertain) to 10 (very certain). | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in psychological distress as assessed by the Hospital Anxiety and Depression Scale | The 14 items will be rated on a 4-point Likert scale (range 0-3), with higher scores indicating a worse condition. | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in quality of life as assessed by the EQ-5D-5L | EQ-5D-5L includes 5 health-related dimensions measured on 5 levels (i.e., no problems, slight problems, moderate problems, severe problems, and unable to do), and health state rated on a visual analogue scale (VAS) with endpoints of 0 (the best health you can imagine) and 100 (the worst health you can imagine) with higher scores indicating a better condition. | from baseline to 4 weeks, 8 weeks, and 12 weeks | 
| Changes in participants' perceived global assessment of change in knee pain | It will be rated on a 5-point Likert scale: Much worse (0), Worse (1), Same (2), Better (3), and Much better (4) | from baseline to 4 weeks, 8 weeks, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee pain, physical therapy, exercise