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PainNCT05173064

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

A study testing The AI-powered Technological Surrogate Physiotherapist and Face-to-face physiotherapist-supervised exercise program in people with Pain and Knee Osteoarthritis, run by The University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Pain, Knee Osteoarthritis
What is being tested?
The AI-powered Technological Surrogate Physiotherapist and Face-to-face physiotherapist-supervised exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteHong Kong
Study dates
20 May 2026to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 50 years of age;
  • Report having knee pain most days of the week;
  • Has radiographic evidence of grade 2, 3, or 4 knee OA on the K-L scale in the posteroanterior and/or skyline view in at least 1 knee;
  • Willing and able, both physically and cognitively, to perform the exercises required in the study protocol;
  • Has normal or corrected-to-normal vision;
  • Able to speak Cantonese and read Chinese, AND
  • Able to provide written informed consent.

Who cannot join

  • Having a history of knee or hip replacement surgery;
  • Being nonambulatory;
  • Having systemic inflammatory arthritis (e.g., gout);
  • Having a history of trauma (e.g., fractures around the knee, dislocation, sprains or tears of soft tissues like ligaments) or surgical arthroscopy of either knee within the past 6 months;
  • Having intra-articular injection to the knee within the past 6 months;
  • Having cognitive impairment;
Show all 9Show fewer
  • Involvement in a similar study (i.e., involving physical exercise or physical therapies for knee pain) within the past 6 months;
  • Undergoing recent or imminent surgery (within 3 months) , OR
  • Having medical co-morbidities that preclude participation in exercise.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Calvin Kalun Or, PhD contact

(852) 3917-2587

klor@hku.hk

Hong Kong1 site
  • 826, Haking Wong Building, Pokfulam, The University of Hong Kong, Hong Kong

    Hong Kong, 000

    Kalun Or, Doctoral degree, (852) 3917-2587, klor@hku.hk

    Letong Li, Master degree

Other trials in Hong Kong

About this study

Official title: Development and Randomized Controlled Trial of an AI-powered Technological Surrogate Physiotherapist (TSP) Dedicated to Quality Enhancement and Cost Reduction in Knee Osteoarthritis Exercise Rehabilitation

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.

Read the 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 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.

Being tested
The AI-powered Technological Surrogate Physiotherapist, Face-to-face physiotherapist-supervised exercise program
Keywords
knee pain, physical therapy, exercise
Medical subject headings
Pain, Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The AI-powered Technological Surrogate PhysiotherapistDevice

    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 programBehavioural

    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.

Study groups in NCT05173064
Study groupRoleWhat they receive
The AI-powered Technological Surrogate PhysiotherapistExperimentalParticipants 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.
Receives: Device: The AI-powered Technological Surrogate Physiotherapist
Face-to-face physiotherapist-supervised exercise programActive comparatorParticipants 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.
Receives: Behavioral: Face-to-face physiotherapist-supervised exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to 12 weeks

  2. 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).

    Measured: From baseline to 12 weeks

Secondary outcomes (6)
  1. 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.

    Measured: From baseline to 12 weeks

  2. Changes in physical function as assessed by timed up-and-go test

    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.

    Measured: From baseline to 12 weeks

  3. 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.

    Measured: From baseline to 12 weeks

  4. 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.

    Measured: From baseline to 12 weeks

  5. 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'.

    Measured: From baseline to 12 weeks

  6. 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'.

    Measured: From baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start20 May 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173064
Sponsor's protocol ID
Feedback System
Status last verified
Apr 2026
First submitted
9 Dec 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10450481
  • 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.

    PubMed 1991946
  • 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.

    PubMed 32767989
  • 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.

    PubMed 16018917
  • 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.

    PubMed 1593914
  • 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.

    PubMed 23680877
  • 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.

    PubMed 22588748
  • 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.

    PubMed 25952346
  • 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.

    PubMed 1540789
  • 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.

    PubMed 20082694
  • 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.

    PubMed 17907147
  • 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.

    PubMed 21954131
  • 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.

    PubMed 33236109
  • 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.

    PubMed 17056608

Questions about this trial

What is this clinical trial studying?

A study testing The AI-powered Technological Surrogate Physiotherapist and Face-to-face physiotherapist-supervised exercise program in people with Pain and Knee Osteoarthritis, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Calvin Kalun Or, PhD ((852) 3917-2587, klor@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI (time frame: From baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173064, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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