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

Not Applicable

• Conditions: Pain
• Interventions: Device: Machine learning-based exercise training system; Device: Video-based exercise training system

• Registration Number: NCT05173064
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07
• Study Start: 2022-11-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Machine learning-based exercise training system	Machine learning-based exercise training system	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.
Video-based exercise training system	Video-based exercise training system	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.

Primary Outcome Measures

Name	Time	Method
Changes in knee pain as assessed by the 5-item pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	from baseline to 4 weeks, 8 weeks, and 12 weeks	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)".
Changes in physical function as assessed by the 17-item physical function subscale of WOMAC	from baseline to 4 weeks, 8 weeks, and 12 weeks	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)".

Secondary Outcome Measures

Name	Time	Method
Changes in severity of knee pain over the previous 7 days as assessed by an 11-point numerical rating scale	from baseline to 4 weeks, 8 weeks, and 12 weeks	0 represents "no pain" and 10 represents the "worst possible pain".
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	from baseline to 4 weeks, 8 weeks, and 12 weeks	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".
Changes in self-efficacy as assessed by the 8-item Arthritis Self-efficacy Scale	from baseline to 4 weeks, 8 weeks, and 12 weeks	Each item will be rated on a scale with response categories ranging from 1 (very uncertain) to 10 (very certain).
Changes in psychological distress as assessed by the Hospital Anxiety and Depression Scale	from baseline to 4 weeks, 8 weeks, and 12 weeks	The 14 items will be rated on a 4-point Likert scale (range 0-3), with higher scores indicating a worse condition.
Changes in quality of life as assessed by the EQ-5D-5L	from baseline to 4 weeks, 8 weeks, and 12 weeks	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.
Changes in participants' perceived global assessment of change in knee pain	from baseline to 4 weeks, 8 weeks, and 12 weeks	It will be rated on a 5-point Likert scale: "Much worse (0)", "Worse (1)", "Same (2)", "Better (3)", and "Much better (4)