Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain
NCT ID: NCT05173064
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
264 participants
INTERVENTIONAL
2025-10-30
2027-03-31
Brief Summary
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Detailed Description
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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 examine the effects of AI-powered Technological Surrogate Physiotherapist, comparing with the effects of the group receiving in-person sessions and effects of the combined group receiving both.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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The AI-powered Technological Surrogate Physiotherapist
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.
The AI-powered Technological Surrogate Physiotherapist
The AI-powered Technological Surrogate Physiotherapist will have three key features:
1. Evidence-based exercise videos instructed by physical therapists
2. Real-time movement feedback and performance score
3. Exercise records.
Face-to-face physiotherapist-supervised exercise program
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.
Face-to-face physiotherapist-supervised exercise program
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.
The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised
Participants will receive an integrated intervention combining conventional physiotherapist-supervised sessions and TSP-supported home exercises (three 30-minute exercise sessions per week for 12 weeks).
The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised exercise program
This group will attend in-person group therapy sessions, while additionally completing weekly home exercise sessions using the TSP system.
Interventions
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The AI-powered Technological Surrogate Physiotherapist
The AI-powered Technological Surrogate Physiotherapist will have three key features:
1. Evidence-based exercise videos instructed by physical therapists
2. Real-time movement feedback and performance score
3. Exercise records.
Face-to-face physiotherapist-supervised exercise program
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.
The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised exercise program
This group will attend in-person group therapy sessions, while additionally completing weekly home exercise sessions using the TSP system.
Eligibility Criteria
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Inclusion Criteria
* age ≥ 50 years,
* report having pain in or around the knee for more than 12 weeks and on most days of the previous month,
* report being diagnosed with knee OA by a physician, have physician-diagnosed knee OA in the medical record, or have radiographic evidence of grade 2 to 3 knee OA on the Kellgren-Lawrence scale in the posteroanterior and/or skyline view or the presence of lateral/posterior osteophytes (the X-rays will be read and classified by our orthopaedic surgeons collaborators to decide on each patient's eligibility to be included in the study),
* are willing and physically and cognitively able to perform (technology-supported) exercises required in the study protocol
* have normal or corrected to normal vision,
* are able to speak and read Chinese,
* are able to provide written informed consent.
Exclusion Criteria
* history of knee or hip replacement surgery,
* non-ambulatory status,
* systemic inflammatory arthritis (e.g., gout),
* history of trauma (e.g., fractures around the knee, dislocation, and sprains or tears of soft tissues, like ligaments) or surgical arthroscopy of either knee within the past 6 months,
* intra-articular injection to the knee within the past 6 months,
* cognitive impairment,
* involvement in a similar study in the past 6 months,
* recent or imminent surgery (within 12 weeks),
* medical co-morbidities that preclude participation in exercise.
50 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Locations
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826, Haking Wong Building, Pokfulam, The University of Hong Kong, Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Identifier Source: org_study_id
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