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The goal of the study is to confirm the idea of AI-powered Technological Surrogate Physiotherapist (TSP), by demonstrating its effectiveness and value as a new technology-based contribution to OA healthcare. Participants will be randomized to one of two groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; or (2) the AI-guided group following the program through the TSP after an initial PT session. All individuals will take part in the study for 12 weeks, and data will be collected at baseline and 12 weeks after randomization.
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 12-week randomized controlled non-inferiority trial will be conducted to compare the effects of the AI-powered Technological Surrogate Physiotherapist with those of in-person physiotherapy sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The AI-powered Technological Surrogate Physiotherapist | Experimental | Participants will be required to perform three 30-minute exercise sessions per week for 12 weeks, with six exercises at any one time. During the exercise sessions, participants will receiveTechnological Surrogate Physiotherapist (TSP) support which will in particular leverage AI to offer innovative features and modules dedicated to enhancing exercise monitoring and supervision, real-time performance feedback, and self-assessment. |
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| Face-to-face physiotherapist-supervised exercise program | Active Comparator | Participants will be required to visit a physiotherapist for usual face-to-face exercise therapy. Also, they will be required to perform three 30-minute home exercise sessions per week for 12 weeks. However, TSP will not be involved in this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The AI-powered Technological Surrogate Physiotherapist | Device | The AI-powered Technological Surrogate Physiotherapist will have three key features:
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI | 0 represents no pain and 10 represents the worst possible pain. | From baseline to 12 weeks |
| Changes in physical function as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) physical function sub-scale | The scale regards the degree of difficulty in performing usual daily activities and higher level activities that involve physical function of the knee. Each item will be rated on a 5-point Likert scale ranging from 'None' (i.e., no difficulty) to 'Extreme' (i.e., extreme difficulty), based on which a normalized total score will be calculated (0 indicating extreme symptoms and 100 indicating no symptoms). | From baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in physical function as assessed by 30-second chair-stand test | 30-second chair stand test (30CST), which measures the number of stands the participant can complete in 30 sec, will be used to assess the general leg strength and functional performance. | From baseline to 12 weeks |
| Changes in physical function as assessed by timed up-and-go test |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Calvin Kalun Or, PhD | Contact | (852) 3917-2587 | klor@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 826, Haking Wong Building, Pokfulam, The University of Hong Kong, Hong Kong | Hong Kong | 000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10450481 | Background | Roberts JM, Wilson K. Effect of stretching duration on active and passive range of motion in the lower extremity. Br J Sports Med. 1999 Aug;33(4):259-63. doi: 10.1136/bjsm.33.4.259. | |
| 1991946 | Background | Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
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| Face-to-face physiotherapist-supervised exercise program | Behavioral | Physiotherapists will give usual face-to-face therapy. The assessment of participants' exercise movements will only be achieved in the traditional manner during face-to-face exercise sessions - by physiotherapists' visual inspection of and professional judgement on postural alignment and effectiveness, with verbal instructions for posture correction. The features of real-time movement feedback and tracking of exercise progress will not be provided. |
|
Timed up and go (TUG) test, which measures the time it takes the participant to standup from the chair, walk 3 meters, walk back to the chair, and sit down, will be used to assess functional mobility. |
| From baseline to 12 weeks |
| Changes in physical function as assessed by maximal isometric strength of the quadriceps and hamstrings | The participant will be instructed to maximally extend/flex each knee for 3 trials, 3 sec each, with a 1-minute rest in between. Verbal encouragement will be given in each trial to ensure the participant makes the maximum effort. The highest force of each muscle in the three trials will be used for data analysis. After each test trial, the severity of pain experienced by the participant during the trial will be assessed using the 11-point numerical pain rating scale. | From baseline to 12 weeks |
| Exercise adherence | Exercise adherence will be indicated by the proportion of sessions and proportion of exercises performed which will be recorded by the TSP system (only for intervention group) and by participants and researchers using a log book. | From baseline to 12 weeks |
| Satisfaction with the therapeutic exercise training | It will be rated by participants using a 7-point Likert scale with anchors of 'Extremely unsatisfied' and 'Extremely satisfied'. | From baseline to 12 weeks |
| Convenience in terms of location and time for accessing the exercise therapy | It will be assessed on an 11-point numerical rating scale, with 0 representing 'Extremely inconvenient' and 10 representing 'Extremely convenient'. | From baseline to 12 weeks |
| 32767989 | Background | Hinman RS, Kimp AJ, Campbell PK, Russell T, Foster NE, Kasza J, Harris A, Bennell KL. Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial. BMC Musculoskelet Disord. 2020 Aug 7;21(1):522. doi: 10.1186/s12891-020-03523-8. |
| 16018917 | Background | Lam CL, Tse EY, Gandek B, Fong DY. The SF-36 summary scales were valid, reliable, and equivalent in a Chinese population. J Clin Epidemiol. 2005 Aug;58(8):815-22. doi: 10.1016/j.jclinepi.2004.12.008. |
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 23680877 | Background | Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 25952346 | Background | McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, Wang S, Schnitzer T. OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):747-60. doi: 10.1016/j.joca.2015.03.005. |
| 1540789 | Background | McAlindon TE, Cooper C, Kirwan JR, Dieppe PA. Knee pain and disability in the community. Br J Rheumatol. 1992 Mar;31(3):189-92. doi: 10.1093/rheumatology/31.3.189. |
| 20082694 | Background | Cottrell E, Roddy E, Foster NE. The attitudes, beliefs and behaviours of GPs regarding exercise for chronic knee pain: a systematic review. BMC Fam Pract. 2010 Jan 18;11:4. doi: 10.1186/1471-2296-11-4. |
| 17907147 | Background | Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Jones RH, Dieppe PA, Reeves BC. Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial. Arthritis Rheum. 2007 Oct 15;57(7):1211-9. doi: 10.1002/art.22995. |
| 21954131 | Background | Hurley MV, Walsh NE, Mitchell H, Nicholas J, Patel A. Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial. Arthritis Care Res (Hoboken). 2012 Feb;64(2):238-47. doi: 10.1002/acr.20642. |
| 33236109 | Background | Chen T, Or CK, Chen J. Effects of technology-supported exercise programs on the knee pain, physical function, and quality of life of individuals with knee osteoarthritis and/or chronic knee pain: A systematic review and meta-analysis of randomized controlled trials. J Am Med Inform Assoc. 2021 Feb 15;28(2):414-423. doi: 10.1093/jamia/ocaa282. |
| 17056608 | Background | Hay EM, Foster NE, Thomas E, Peat G, Phelan M, Yates HE, Blenkinsopp A, Sim J. Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial. BMJ. 2006 Nov 11;333(7576):995. doi: 10.1136/bmj.38977.590752.0B. Epub 2006 Oct 20. |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |